Jerry Bauer Session Info: 5/29/2009 Fundamentals of Clinical Trial ...

2009 Participant Reports on ASCO Sessions

1 | P a g e 8 / 1 4 / 2 0 0 9 D r a f t – N o t f o r D i s t r i b u t i o n

Jerry Bauer Session Info: 5/29/2009 Fundamentals of Clinical Trial Design & Methodology 267

Extended Education Hours credit: 2.25

Presenter1: Excellent Presenter 2: Excellent Presenter 3: Excellent Presenter 4: Excellent

Comment: Patient consent is a process & not just a document. The patient must understand each step in the trial

process & the reason for it.

Significant findings reported: Randomized Phase III Clinical trials are our best source of information concerning

the relative effects of competing treatments, particularly in light of the trend towards personalized treatment,

Messages I will take to my constituency: RCTs can offer participants access to state of the art therapies as well as

provide critical scientific information for development of even better therapies. The trials cannot proceed

without participation.

Did the course materials help you understand this session? Yes

Explain: The exposure we had in regards to trials by Dr. Rodriguez & Dr. Bodur put my head in the right mode to

focus on the subjects of research & methodology.

Additional topics: Acronyms, acronyms, acronyms, their definitions & usage should be covered better. The

initials alone constitute another language aside from the 4,5 & 6 syllable words the researchers speak.

Jerry Bauer Session Info: 5/29/2009 Fundamentals of Clinical Trial Design & Methodology 267



Comment: Patient consent is a process & not just a document. The patient must understand each step in the trial

process & the reason for it.

Significant findings reported: Randomized Phase III Clinical trials are our best source of information concerning

the relative effects of competing treatments, particularly in light of the trend towards personalized treatment,

Messages I will take to my constituency: RCTs can offer participants access to state of the art therapies as well as

provide critical scientific information for development of even better therapies. The trials cannot proceed

without participation.


Explain: The exposure we had in regards to trials by Dr. Rodriguez & Dr. Bodur put my head in the right mode to

focus on the subjects of research & methodology.

Additional topics: Acronyms, acronyms, acronyms, their definitions & usage should be covered better. The

initials alone constitute another language aside from the 4,5 & 6 syllable words the researchers speak.

Jerry Bauer Session Info: 5/30/2009 Diet, Exercise & Cancer: Does the evidence Support Lifestyle

Modification as Part of Cancer Treatment? 137 Educational Hours credit: 1.25



Presenter1: Very good Presenter 2: Very good Presenter 3: Excellent Presenter 4:

Comment: Only one showed enough enthusiasm but all were knowledgeable

Significant findings reported: Keeping your body healthy increases mortality.

Messages I will take to my constituency: You are what you eat & drink & your body responds likewise. 1-2

alcoholic drinks per day is cardio-protective. Dietary supplements & vitamins (especially Mulit-) are questionable.

Vitamin D - Conclusions: Many cancer patients are "D" deficient. "D" deficiency also noted with overall

mortality & health problems. Increasing vitamin D is a reasonable goal. Recommended doses: 19-50 years = 200

IU/day 50-70 years = 400 IU?day; 70+ years = 600 IU/day Canada's cold winters + 1000/day while "D" advocacy

groups = 10,000/day Diet & Physical Activity Guidelines for Survivors Weight Guidelines needed Exercise area &

guidance needed create a healthy diet Reduce alcohol intake Watch out for unproven supplements Next Step =

Random control trials for exercise benefits.

Did the course materials help you understand this session? N/A to this session (pre-ASCO materials not focused

on this topic)

Explain:

Additional topics:

Jerry Bauer Session Info: 5/30/2009 Stage Specific Therapy for Esophageal Cancer - A logical approach

in the absence of Level I Data 135 Educational Hours credit: 1.25

Presenter1: Excellent Presenter 2: Excellent Presenter 3: Excellent Presenter 4:

Comment: Esophageal Cancer has reached epidemic proportions in the US & Western Europe. It is now the

fastest growing diagnosis of all cancers.

Significant findings reported: There are new stagings coming up that may separate adeno & squamous cell from

each other with squamous cell becoming part of throat cancers instead of the GI tract. Possible Stage-specific

paradigms are being discussed in relation to EC.

Messages I will take to my constituency: Staging creates the treatment regimen. Newer chemo therapies are

helping increase the survival rate but early detection is still the biggest single problem along with education &

communication including within the medical community. Multi-modality Therapy seems to be reducing the

need for the radical surgery normally associated with this diagnosis. Timing of the regimen is also being affected

by newer therapies & drugs. Less invasive laparoscopy is becoming more common today.


on this topic)

Explain: This session was more like a discussion of general findings as opposed to a specific factor as most

research is based on.

Additional topics: I need to study the glossary of terminology more completely & I find it is easier as my exposure

increases. The difficulty is that I am not immersed in it like the medical & research communities are.

Jerry Bauer Session Info: 5/30/2009 Genetic Testing & Society 124 Educational Hours credit: 1.25




Comment: "Direct To Consumer" advertising increases demand for genetic testing.

Significant findings reported: 1. More than 50% of BRACA 1/2 testing is done in non-academic settings which can

lead to errors in the collection & processing of the information. 2. Incorporating into busy clinical practices is not

always good due to lack of detail & focus 3. The impact on "informed consent" is virtually unknown, May be far

from accurate 4. Traditional models of informed consent have been challenged. 5. Alternative models &

policies are needed to insure integrity of the trial & understanding by the participant in the ON-GOING parts of

the process. 7. Research evaluating patient preferences & expected (?) outcome is needed.

Messages I will take to my constituency: Participants must watch out for proper and understandable disclosures.

It is the old adage in action but with far more serious consequences, "Buyer Beware!"


Explain: I think some of the discussion we had with Dr Bodur was helpful to understanding the seriousness of

"consent".

Additional topics: Definitions of terminology & acronyms again.

Jerry Bauer Session Info: 5/30/2009 Genetic Testing & Society 124 Educational Hours credit: 1.25


Comment: "Direct To Consumer" advertising increases demand for genetic testing.

Significant findings reported: 1. More than 50% of BRACA 1/2 testing is done in non-academic settings which can

lead to errors in the collection & processing of the information. 2. Incorporating into busy clinical practices is not

always good due to lack of detail & focus 3. The impact on "informed consent" is virtually unknown, May be far

from accurate

Messages I will take to my constituency: Participants must watch out for proper and understandable disclosures.

It is the old adage in action but with far more serious consequences, "Buyer Beware!"


Explain: I think some of the discussion we had with Dr bodur was helpful to understanding the seriousness of

"consent".

Additional topics: Definitions of terminology & acronyms again.

Jerry Bauer Session Info: 5/31/2009 The Prognostic Value of Polymorphisms in the insulin - Like the

growth factor Receptor Pathway in patients with locally advanced Pancreatic cancer.

Educational Hours credit: 1.25


Comment: Host characteristics that may predict utility of insulin/IGF targeting therapies are becoming more

prevalent in many parts of the world. What are t or 3 ways to win by inhibiting the hedgehog pathways? Hit

tumor cells directly & hit stroma supporting t



Significant findings reported: There was a 40% reduction in cancer deaths among 10,309 diabetics who were

using metfarmic instead of insulin! WOW! Major findings in the late 1990's to present - when the hedgehog

pathway is inappropriately activated in adults it can lead to increased incidence of skin, prostate, lung, breast,

small cell lung & many other forms of cancer. Hedgehog pathway is mentioned as an Important signaling

pathway to nearly every type of cancer known.

Messages I will take to my constituency: If you are diabetic & have cancer investigate the options for an insulin

substitute. If there is no consistent target in a majority of patients pancreatic cancers, look at the stroma of the

tumor as the Achilles heal of patient tumors A combination of gemciabine+nab-paclitaxel receives a high

response rate & excellent median survival rate for patients with recommended dose.


Explain: Same as before.

Additional topics:

Jerry Bauer Session Info: 5/31/2009 Scientific Mentor Session for Patient Advocates 0 Mentor Session

Hours credit: 1.00


Comment: Being in a smaller room & with my peers felt more comfortable.

Significant findings reported: I was stunned to hear all the problems getting the proper number of participants

for these trials with the huge number of newly diagnosed individuals each year. I was also somewhat taken aback

when I asked what we, as patient advocates, could do to assist in the recruiting process, thinking that our

participation in that part of the process could help since we are "peers" to the potential recruits.

Messages I will take to my constituency: My message to the participants at The Wellness Community will be to

encourage our members to participate enthusiastically in trials if they are interested & invited. I will also act as

an advocate for them if they wish in attending their recruitment appointments.


Explain: Same as before.

Additional topics: Acronyms!

Jerry Bauer Session Info: 5/31/2009 Gastrointestinal (Non-Colorectal) Cancer 0 Poster - Vashist Presenter

Hours credit: 0.25

Presenter1: Very good Presenter 2: Presenter 3: Presenter 4:

Comment: Heavy accent was sometimes difficult to understand but very knowledgeable & professional

Significant findings reported: Presence of Bone Marrow Micrometastases proved to be the strongest predictor of

Overall Survival with little of no variance between Adeno & Squamous Cell with tumor size following if patient is

BMM+.



Messages I will take to my constituency: Early detection prior to lymph node involvement becomes critical

especially prior to metastases. Ultimate goal is to continue life expectancy increases & education process to

become more public and raise awareness.


on this topic)

Explain:

Additional topics:

Jerry Bauer Session Info: 5/31/2009 Gastrointestinal (Non-Colorectal) Cancer 0 Poster - Goldman,

Presenter Hours credit: 0.25

Presenter1: Good Presenter 2: Presenter 3: Presenter 4:

Comment: Goldman - Presenter - seemed pre-occupied with female attendant

Significant findings reported: No significance advantage to surgery prior to treatment. We had considerable

discussion about non-invasive Laparoscopic surgery compared to my THE procedure & my overall health at the

time. He indicated some surprise to find I had been on a regimen that included 5FU.

Messages I will take to my constituency: Oxaliplatin + 5FU + Extended Beam Radiation give the body time to

strengthen prior to surgery if needed providing the patient is prepared to exert.


on this topic)

Explain: Because of the one-on-one nature of posters one had to be there to enjoy the interaction.

Additional topics:

Jerry Bauer Session Info: 5/31/2009 Physical, Psychological & Cognitive Challenges of Long Term

Cancer Survivors 156 Educational Hours credit: 1.25


Comment: Survivorship is a continuum, integrated into cancer care. Patients want the DR to start conversing

about emotional needs & Dr wants patients to start. Nobody wins that way. Since the DR is the "expert" he/she

should lead the way. Many examples given

Significant findings reported: 2010 goal is 70% survival rate. Majority age is 65+ & is the largest group. Strong

health disparity by race. Majority of survivors are 90+% breast, 98% prostate, +colon & rectal in order.

EMOTONAL needs are the #1 UNMET NEED. Oncologists underestimate the "most ill".

Messages I will take to my constituency: "Survivor" from day of diagnosis. 15-16 Million survivors now in the US.

More consideration must be given to long term effects, needs, etc. Older survivors face normal aging & co-

morbidity & younger face infertility, development, cognitive problems. Toxicity assessed after last drug dose is

often LATE. Integrate & refer to a good source like TWC or APOS-Society.org & CancerCare.org




Explain: Our discussions made me feel more confident asking questions from the advocate point of view.

Additional topics: Acronyms & abbreviations.

Jerry Bauer Session Info: 6/1/2009 Systems Biology, Cancer Therapeutics & Personalized Medicine 172

Educational Hours credit: 1.25


Comment: A bright spot on a not too distant horizon.

Significant findings reported: 1. Opportunity now to match drugs to patients & tumors 2. 100s of anti-cancer

drugs now in Phase II/III trials 3. Survey of 60+ drugs & compounds reveal substantial breast cancer sub-types

specificity which is explained in part by epigenomic & genomic differences 4. Science is now able to break down

more specifically cancer types & match drugs known to react positively, thru genomics & epigenomics, and

greatly enhance personalized therapies for effect & reduce toxicity at the same time

Messages I will take to my constituency: Recent genomics strategies are making it more clear how cancer

signaling networks - thus therapies can now be directed to more personalized care. Cetuximab generates a

response to a biopsy which indicates the direction of susceptibility for treatment. We need combination therapy

trials to better design groups that will have positive results from personalized therapies for effects.


Explain: Same as previously mentioned

Additional topics:

Jerry Bauer Hours credit: 14.75



BARBARA BECKWITH Session Info: 5/30/2006 Breast Cancer Patients' Quality of Care: Does Racial Concordance

Matter or is it Just a Matter of Trust? 0 POSTER Hours credit: 0.25

Presenter1: N/A Presenter 2: N/A Presenter 3: N/A Presenter 4: N/A

Comment:

Significant findings reported: Trust seems to be an issue-e as far as Quality of Care is concerned

Messages I will take to my constituency: Advocacy is needed to be sure that doctors and office staff increase

effective intercultural communication.


on this topic)

Explain: Intercultural communication was not materials provided before the conference.

Additional topics:

BARBARA BECKWITH Session Info: 5/20/2009 Genetic Testing and Society 0 Education Session Hours credit: 1.25

Presenter1: Excellent Presenter 2: Very good Presenter 3: Very good Presenter 4:

Comment:

Significant findings reported: Lynch Syndrome caused by mutations.

Messages I will take to my constituency: Background info on Lynch syndrome and why genetic testing can be

important to many survivors


Explain:

Additional topics: Screening for embryos. Is this premature?

BARBARA BECKWITH Session Info: 5/29/2009 Fundamentals of Clinical Trials Deign ad Methodology 0

Extended Education Session Hours credit: 2.25

Presenter1: Excellent Presenter 2: Very good Presenter 3: Excellent Presenter 4: Very good

Comment:

Significant findings reported: Over estimating the benefit from Phase I Trials Consent is a process or sequence

Messages I will take to my constituency: The use of the different Phases of Trials. Be sure that the group

understands what happens in the different phases .


Explain:

Additional topics: The biology of Phase O Trials.



BARBARA BECKWITH Session Info: 5/30/2009 ASCO PANELISTS REVIEW OF RESEARCH Hours credit: 1.00

Presenter1: Excellent Presenter 2: Excellent Presenter 3: Excellent Presenter 4: N/A

Comment:

Significant findings reported: Toxicity is carefully monitored in trials. Outreach to train primary docs is critical

Messages I will take to my constituency: Function of different types of medicines used in Chemo.


Explain:

Additional topics:

BARBARA BECKWITH Session Info: 5/30/2009 Patient and Health System Disparities in Timeliness of Treatment

for Individuals with Colorectal Cancer 0 POSTER A13 Hours credit: 0.25

Presenter1: N/A Presenter 2: N/A Presenter 3: N/A Presenter 4: N/A

Comment:

Significant findings reported: Delay in care of Black and Hispanic patients more significant than white.

Messages I will take to my constituency: Be proactive in Colorectal screenings. Do more with educating the

community. Early detection can save lives.


on this topic)

Explain:

Additional topics: Strategies for educating the community on colorectal screenings.

BARBARA BECKWITH Session Info: 5/30/2009 Genetic Cancer Risk Assessment within the Community Oncology

Practice: Opportunities, Pitfalls, and Resources for Program Development 0 Education

Session Hours credit: 1.25


Comment:

Significant findings reported: More training is needed for docs and counselors

Messages I will take to my constituency: Genetic testing could save lives.


Explain:

Additional topics: Limitations to genetics counseling.



BARBARA BECKWITH Session Info: 5/31/2009 ASCO PANELISTS Advocate Review Hours credit: 1.00


Comment:

Significant findings reported: Targeted therapy prolonged survival by 30%. Immune Therapy by Kantock still

active. Survival benefit but QOL is poor

Messages I will take to my constituency: We need more info on triple negative breast cancer.


Explain:

Additional topics:

BARBARA BECKWITH Session Info: 5/31/2009 Plenary Session Including Science of Science of Oncology Award

and Lecture 0 Plenary Presentation Hours credit: 3.00


Comment:

Significant findings reported: PARP inhibitors prevent tumor cells from repairing damage to their DNA. BSI-201 is

a drug that is the first breach in the previously impenetrable wall of triple negative breast tumor. Vaccine to treat

lymphoma is created using protein from patient's own tumor reduced risk of recurrence.

Messages I will take to my constituency: There is help for triple negative Vaccines are good cancer fighters

There still is not a cure


Explain:

Additional topics:

BARBARA BECKWITH Session Info: 5/31/2009 New Endpoints for New Treatments: A Time for Change in

Assessing Treatment Benefit 0 Education Session Hours credit: 1.25


Comment:

Significant findings reported: Some trial reports are using non final analysis too early to be written about.

Endpoints should be well validated. Surrogate endpoints present problems

Messages I will take to my constituency: Clinically relevant endpoints are necessary


Explain:

Additional topics: Waterfall plots Spider plots



BARBARA BECKWITH Session Info: 5/31/2009 New Targeted Therapies: Predictors of Response and Resistance 0

Education session Hours credit: 1.25


Comment:

Significant findings reported: All lung cancer need genotyping Multiple resistance in different lesions in same

organ Increase in survival

Messages I will take to my constituency: Info about KRAS and no inhibitor used. More identification of genes

needed


Explain:

Additional topics: Types of resistance to meds.

BARBARA BECKWITH Hours credit: 12.75



Katie Brown Session Info: 5/29/2009 Fundamentals of Clinical Trial Design and Methodology 267


Presenter1: Very good Presenter 2: Very good Presenter 3: Barely understood Presenter 4: Very good

Comment: Topic of test of hypothesis and errors and meaning of statistical data was a bit difficult to follow.

Don't know if it was the actual content or if it was the presenter.

Significant findings reported: Basis and basics, Fundamentals and Ethics reviews. Nothing blockbuster or

groundbreaking here.

Messages I will take to my constituency: How to interpret results, analysis of results and questions to ask in

order to obtain results.


Explain: They were helpful in re: terms, etc..I was able to understand the medical abbreviations and was familiar

with the terminology used.

Additional topics:

Katie Brown Session Info: 5/30/2009 Economics of Cancer Care: It's Everyone's Problem 143

Education Session Hours credit: 1.25


Comment: I felt like this was a common sense session really and don't think I benefited in attendance.

Significant findings reported: No significant findings. Explanations of the Oncologist, the medial and the cost of

cancer having a wide impact.

Messages I will take to my constituency: One out of five dollars is spent on healthcare in the US. Growth in

spending on cancer outweighs the gross domestic product. 89 billion spent for direct medical cost of cancer and 2

trillion on healthcare itself. Drugs account for 10% of healthcare spending with cancer drugs #1 among hospital

and clinical drug expenditures. It costs 1 billion to develop a new therapeutic. Cost is a component of decision

making for patients.

Did the course materials help you understand this session? No

Explain: This was not on the topic or research.

Additional topics:

Katie Brown Session Info: 5/30/2009 Research Review Session 0 Patient Advocacy Programs Hours credit:

1.00


Comment: This was a very real approach to review and elaborate on the sessions of the day. There presenters

were very thorough in answering all of our questions and were very likable.



Significant findings reported: No significant findings, however, this was an invaluable meeting to clarify

information we had heard throughout the day in earlier sessions.

Messages I will take to my constituency: A clearer understanding of some of the content presented in earlier

sessions.


Explain: In terms of gene typing and the new therapies available or on the horizon

Additional topics: It would have been great to have had access to these experts after each session! They were

really great!

Katie Brown Session Info: 5/30/2009 Lung Cancer- Local, Regional, and Adjuvant Therapy 60 Poster

Discussion Hours credit: 1.00


Comment:

Significant findings reported: Recommendation of chemotherapy before AND after surgery as adjuvant therapy

which can induce tumor regression.

Messages I will take to my constituency: The recommendation of chemotherapy before and after surgery to

induce tumor regression. Adjuvant therapy becoming the standard of care, even though there is no benefit to

those w/ RAS mutation. Study shows immunochemistry & gene copy = good clinical evidence of anti tumor

growth w/EGFR inhibitor=progression free survival.


Explain: yes when the speakers spoke about the genomic studies

Additional topics:

Katie Brown Session Info: 5/30/2009 The New Staging System: What Does it Mean? 121 Education


Presenter1: Excellent Presenter 2: Excellent Presenter 3: N/A Presenter 4:

Comment: Presenter number 3 was from France and held a very strong accent. This is why he was difficult to

follow. He also blew thru his slides and presentation very quickly.

Significant findings reported: The staging system for LC has been changed to reclassify stages and include

subcategories for both NSCLC and SCLC

Messages I will take to my constituency: The reclassification of stages and an explanation of the completely new

staging system for SCLC, from "limited stage or extensive stage" to a T-factor analysis staging system much like

NSCLC has been staged.


Explain: The topic discussed here was not clinical trials or genomic or genetic research.



Additional topics: I would like to have seen the presenters elaborate on the benefits of the new staging system,

especially for SCLC in terms of therapeutic advantages or surgical advantages or prognosis advantages. I had to

sort of guess until I was able to discuss it per

Katie Brown Session Info: 5/31/2009 160 0 Educational Hours credit: 1.25

Presenter1: Excellent Presenter 2: Excellent Presenter 3: Presenter 4:

Comment: Discussed chemotherapy and targeted therapy in older people.

Significant findings reported: Tumors may differ in older v. younger patients. Toxicity problem in elderly--there is

a need for clinical trials studying this. Recommendation to start older patients with less drug and increase it

gradually according to tolerance.

Messages I will take to my constituency: 40% of those with LC are over 70 years old. Expert had doubts about

cisplatin-base tolerability in resected elderly patients. There is very little data of patients over 70. To date there

is no data for neoadjuvant. Combination of rad/chemo evaluated by the individual. The ECOG 4559 trial on

Bevecezumab showed no survival benefit with toxicity. Elderly at greater risk of infection but there needs to be

trials in the toxicity of chemo in older adults. Only 34% of elderly are even eligible for current clinical trials.


Explain: The contented presented was not the same as the documents provided.

Additional topics:

Katie Brown Session Info: 5/31/2009 New Targeted Therapies- Predictors of Response and Resistance

191 Education Session Hours credit: 1.25

Presenter1: Good Presenter 2: Excellent Presenter 3: Very good Presenter 4:

Comment: Speaker one was Dr. Ravaud and he had a very thick accent and spoke very very quickly. He was

difficult for me to understand and follow.

Significant findings reported: No significant findings for lung cancer that I could determine. This session was

billed for lung and colon cancer but the majority of this session speakers spoke about colon and kidney cancer.

Messages I will take to my constituency: Survival rate is higher of resection of a single site metastasis and that

single solitary lesion does better than multiple lesions in one site.


Explain: This session was all about surgery, and review of clinical trials involving survey of single site or multiple

site metastasis.

Additional topics:



Katie Brown Session Info: 5/31/2009 Making Sense of Molecular Markers in LC 168 Education Session Hours

credit: 1.25

Presenter1: Good Presenter 2: Barely understood Presenter 3: Presenter 4:

Comment: I took photos of all the slides and will have to review this content at a later date to determine it's

relevance. This session was a review of clinical trials and the slides and data were discussed very quickly.

Significant findings reported: Names of clinical trials and molecular marker names.

Messages I will take to my constituency: Information about the clinical trials involving molecular markers in lung

cancer.

Did the course materials help you understand this session? YesNo

Explain: I recognized some familiar terms and understood the summary of the sessions. I just had a difficult time

with the speakers speeding thru the examples of clinical studies and what their significance was.

Additional topics: I just wished I had a better knowledge of the clinical trial slides. I have to examine them

carefully and then read the reviews on them before I determine whether or not the findings were of a significant

value. When speakers are using them as an exampl

Katie Brown Session Info: 6/1/2009 Small Cell Lung Cancer: Pathology and Biology 153 Education


Presenter1: Very good Presenter 2: Very good Presenter 3: Presenter 4:

Comment:

Significant findings reported: No blockbuster findings but I was pleased that there were many clinical trials trying

to find something that worked on this type of lung cancer. To date in the last 10 years there only been one

approved for SCLC and that's oral topotecan.

Messages I will take to my constituency: I will let them know that researchers ARE indeed studying this disease

and doing clinical trials to find something that might work to improve progression free survival with low toxicity.

Researchers are trying BCL-2 Inhibitors, Angiogenesis Inhibitors, and Chemotherapeutic Agents in their trials. So

far none have been promising. There is now a trial with Picoplatin and another with Temozolomide as a third line

therapy and I will be keeping my eye on those.

Did the course materials help you understand this session? YesN/A to this session (pre-ASCO materials not

focused on this topic)

Explain:

Additional topics:



Katie Brown Session Info: 6/1/2009 Lung Cancer- Metastatic 61 Poster Display Hours credit: 0.00

Presenter1: N/A Presenter 2: Presenter 3: Presenter 4:

Comment: I didn't know what this was but it turned out to be a large room with poster displays of clinical trials.

The handouts and copies of each trial was very beneficial.

Significant findings reported: unknown

Messages I will take to my constituency: I am able to provide the posters and copies of clinical trials involving

metastatic lung cancer to my constituency and to the oncologist I work with in my area who were unable to

attend ASCO this year.


Explain: No topic discussion.

Additional topics:

Katie Brown Hours credit: 11.75



Lourie Campos Session Info: 5/30/2009 Diet, Exercise, and Cancer: does the Evidence Support Lifestyle

Modification as Part of Cancer Treatment? 137 Education Session Hours credit: 1.25


Comment: Good session.

Significant findings reported: (1) Weight at time of breast cancer diagnosis increases rate of recurrence (2)

Exercise is feasible in cancer patient populations - they will feel better and will have less fatigue (3) need

randomized trials to find out if it is a benefit for cancer survivors but this is a challenging study to do (4) Cancer

can increase or decrease metabolic rate (5) Guidelines established for weight management in general

populations should be applied to cancer survivors (6) TEE of food - 5 - 10%, TEE for physical activity is 5 - 30%, TEE

for metabolic rate is 60 - 75% (7) Supplements: no benefit with vitamin E; in fact may increase risk (8) Vitamin D

(400 IU) a day does not reduce risk of invasive breast cancer (9) Vitamin D shows small decreased risk of CRC (10)

Many patients are vitamin D insufficient. Patients that are deficient do "worse". (11) Increasing vitamin D intake

shows benefit.

Messages I will take to my constituency: Recommendations on Vitamin D dose is currently being reviewed and

will most likely increase. Taking vitamin D has shown a small decrease in CRC risk, but taking too much can tip

you into suboptimal health. Vitamin D is good for cardiovascular health.


on this topic)

Explain:

Additional topics: None

Lourie Campos Session Info: 5/30/2009 Gastrointestinal (Colorectal) Cancer 9 Oral Abstract Session Hours credit:

1.50


Comment: Should have an option to say very and barely understood or way over my head. This would be my

rating for Dr. Charles Fuchs. They were all very good presenters even though I as a lay person had a challenging

time understand the more technical concepts and

Significant findings reported: (1) Stage I and Stage II colon cancers may be 2 totally different tumors rather than a

progression in disease. Unlike breast cancer, there are no biomarkers for CRC. (2) No significant interation

between age and efficacy of CRC treatment; patients over 70 can benefit from combination therapy (3) 83% of

stage II CRC recurs within 3 years so researchers use a 2 year DFS as a primary endpoint in stage II CRC. Maximum

benefit of tx is seen in first 2 years.

Messages I will take to my constituency: Older patients diagnosed with CRC should absolutely talk to their

oncologist about treatment options!


on this topic)

Explain:



Additional topics: Acronyms and definitions: DOS - Disease Free Survival; OS - Overall Survival; TTR- Time to

Recurrence Microsatellite Instability in CRC


1.50






progression in disease. Unlike breast cancer, there are no biomarkers for CRC. (2) No significant interaction







on this topic)

Explain:




1.50






progression in disease. Unlike breast cancer, there are no biomarkers for CRC. (2) No significant interaction









on this topic)

Explain:



Lourie Campos Session Info: 5/30/2009 Advances in Chemoprevention of Colorectal Cancer - Lessons from

Recent Trials 184 Education Hours credit: 1.25

Presenter1: Very good Presenter 2: Excellent Presenter 3: Good Presenter 4:

Comment: 3rd speaker was very technical

Significant findings reported: NSAIDS prevent neoplasms in the large bowel. But it takes 10 years of taking

aspirin that one sees the preventative effects. Studies have shown a substantial reduction in polyps for FAP

patients (Familial Adenomatousn Polyposis). Higher doses of NSAIDS is not needed but better but you must

consider the side effects and possible toxicity from consuming large amounts of NSAIDS over time.

Messages I will take to my constituency: Taking aspirin can have a preventive effect on colon cancer, but it takes

10-15 years. Frequent, continuous use is required although, this can cause GI problems (abdominal bleeding).

Check with your doctor before using NSAIDS prophylactically.


on this topic)

Explain: Did not participate in all Pre-ASCO lectures or webinars

Additional topics:

Lourie Campos Session Info: 5/31/2009 Cancer Vaccines: Where do we go from Here? 123 Educational


Presenter1: Barely understood Presenter 2: Way over my head Presenter 3: Way over my head

Presenter 4:

Comment: Following the example of infectious disease vaccines, are there therapeutic vaccines for cancer?

Significant findings reported: (1) 2nd gen. lymphoma vaccines are in development (2) Ideal cancer vaccine

strategy would be Immunostimulating or Immunostimulatory - Tcell Tumor (this is was challenging to understand)

(3) Future of cancer treatment: (a) combining vaccines with biologic agents; (b) integration of vaccines with stem

cell; (c) adoptive cell therapy

Messages I will take to my constituency: The HPV vaccine is just the beginning of cancer vaccines. Much

research is happening in this area and there is reason to be optimistic.


on this topic)

Explain:



Additional topics: Would need to have an extensive science background!

Lourie Campos Session Info: 5/31/2009 Plenary Session 1 Plenary Hours credit: 3.00

Presenter1: Good Presenter 2: Barely understood Presenter 3: Good Presenter 4: Barely

understood

Comment: Oops! I've been rating the presenters not my understanding of the material! The presentation on

follicular lymphoma was difficult to understand. One note I wrote was: "ritaximab with chemo improves survival

and Biovax ID - improves DFS following PACE in

Significant findings reported: (1) 80% of ovarian cancer patients will relapse. Using CA 125 alone to treat earlier

versus delivering treatment when symptoms are present for recurrence has shown no difference in survival. (2)

"Early chemo" based on a CA-125 only does not improve QOL. It actually makes it worse. (3) If women are

offered a choice, most will opt for regular CA 125. (4) PARP 1 inhibitor (Poly ADP ribose) gets involved in DNA

damage repair. PARP inhibitors kill cells deficient in BRACA 1 - 2. (5) Study on Bevicizumab given to colon cancer

patients for an additional 6 months after chemo was shown to have not statically significant effect in disease free

survival over 5+ years. This was leaked to USA Today. However, the study did show a benefit to disease free

survival in the 1st year it was utilized. Further studies need to examine a longer duration of administering Bev.

Messages I will take to my constituency: (1) Get educated about the CA-125 test. Know its limitations.


on this topic)

Explain:

Additional topics: Cox Proportional Hazard Model DNA repair

Lourie Campos Session Info: 5/31/2009 Physical, Psychological, and Cognitive Challenges of Long-Term

Cancer Survivors Education Session Hours credit: 1.25


Comment: Confirmed some of my experiences. Dawn Hirshman presented for Shapiro.

Significant findings reported: (1) Definition of survivor: from the day of diagnosis through the end of life as

survivorship is a continuum. (2) Largest group of survivors are over 65 (3) Growing number of young adult

cancer survivors (4) 2010 Healthy People 2010 goal of 70% of cancer survivors at 5 years will be met. (5)

Implications of a growing number of cancer survivors is that there is great consideration of long-term effects.

Questions that remain: What is the appropriate follow-up care? Coordination of care? How to reach underserved

populations? (6) Need to know more about toxicities of drugs and long term effects on ADL (activities of daily

living). (7) Survivors are at greater risk of psychological problems; higher risk of suicide, depression, post-

traumatic stress syndrome, sexual dysfunction. (8) Hormonal changes which can be caused by treatment can

cause symptoms of depression (9) Should integrate sexual health in follow-up care (10) Patients are willing to

discuss how they are feeling if the doctor would ask, but many docs are uncomfortable doing so and instead defer

to the patient to bring it up. (11) Greater decline in cognitive function in survivors not age related. Potential

mechanism for this: neurotoxicity (more chemo going beyond blood brain barrier); genetic predisposition,



cytokines, sex hormone drop (12) There are structural and functional brain changes in those who have received

chemo. This was shown as a change in grey matter. (13) For self-reported cognitive problems, screen for anxiety,

depression and fatigue first and treat those since these can lead to decreased Q of L.

Messages I will take to my constituency: (1) Discuss long-term effects of your treatment with your oncologist.

(2) Talk to your oncologist, primary care doctor about how you are feeling. Ask for help. (3) Talk about sexual

health with your doctor.


on this topic)

Explain:

Additional topics: Effects of Neurotoxicity

Lourie Campos Session Info: 5/31/2009 Gynecologic Cancer 13 Oral Presentation Hours credit: 3.00

Presenter1: Very good Presenter 2: Very good Presenter 3: Very good Presenter 4: Very good

Comment: All were technical but very good. The later speakers were definitely over my head. There were short

graphic videos and pictures shown - very interesting.

Significant findings reported: (1) Using information learned from performing sentinel node biopsies in breast

cancer patients, sentinel node biopsy in early cervical cancer is proving beneficial. This can prevent pelvic

lymphadectomies associated with radical hysterectomy. (2) Vulvar cancer is very rare. Biology of vulvar cancer is

very different from breast cancer so technology used for breast ca, is not as transferable (like SN). As a result of

its rarity, GOG 173 study has a long accural period - 10 years. (3) Cervical cancer is becoming a rare disease in the

western world but it is the 2nd leading cause of cancer in women worldwide (4) Gemcitabine synergizes with

radiation and with Cisplatin. The combination of Gem/Cis/Rad resulted in more deaths and hospitalization and

was more toxic but had better overall survival for cervical cancer patients. (5) Evidence support concurrent

chemoradiation/adjuvant chemo for cervical cancer - new standard of care. (6) Still don't know about long term

side-effects of abdominal radiology (7) More studies needed on sequence of giving Gem (may be less toxic if

given at a different time)

Messages I will take to my constituency: (1) In early stage cervical cancer, targeted node sampling may be more

relevant than full node dissection. In my case, this may have prevented the lymphedema I now have in my legs.

(2) If you are diagnosed with cervical cancer, talk to your doctor about concurrent chemoradiation and adjuvant

chemotherapy as newest standard of care. Bring information with you.


on this topic)

Explain:

Additional topics: The difference between progression free survival, overall survival, disease free survival.

Categories of drugs.

Lourie Campos Session Info: 6/1/2009 Colorectal Cancer Screening: Updated Guidelines and Future

Directions Educational Session Hours credit: 1.25



Presenter1: Very good Presenter 2: Very good Presenter 3: Way over my head Presenter 4:

Comment: Good session. Third presenter was very technical.

Significant findings reported: (1) Virtual colonoscopy is more expensive, requires the same prep, is not widely

available, not covered by all insurance plans. ACS recommends but MedPac will not cover (Medicare) stating

insufficient evidence (2) Virtual colonoscopy may not detect "flat" or "depressed" polyps (3) CT colonography

safe? Perforations are rare, fair amount of exposure to radiation; need traditional colonoscopy if polyp is found.

(4) Traditional colonoscopy still effective (5) Polyp removed endoscopically represents primary prevention (6)

Fecal DNA more accurate to diagnosing CRC than determining blood in sample?

Messages I will take to my constituency: (1) Average screening is every 10 years; if polyps are removed, every 3-4

years (2) tubular polyps are more worrisome than sessile ones (3) Virtual colonoscopy requires same prep! (4)

Traditional colonoscopy still effective (5) Fecal DNA more accurate to diagnosing CRC than determining blood in

sample?


on this topic)

Explain:

Additional topics: Epigenetic markers, DNA

Lourie Campos Session Info: 6/1/2009 New Advances in Gynecologic Cancers 257 Clinical Science

Symposium Hours credit: 1.00

Presenter1: Way over my head Presenter 2: Good Presenter 3: Way over my head Presenter 4:

Good

Comment: The moderators were easier to understand. Some audience members challenged research findings.

Significant findings reported: Intraperitoneal cisplatin and paclitaxel given in a 24 hr period causes abdominal

pain.

Messages I will take to my constituency: Risk for recurrence of early stage ovarian cancer depends on grade of

disease.


on this topic)

Explain:

Additional topics: Need to be a research scientist to understand.

Lourie Campos Hours credit: 17.50



Helen Davis Session Info: 5/29/2009 Fundamentals in Clinical Trial Design 267 Education Hours credit:

2.25


Comment:

Significant findings reported: I found the seven criteria to ethics in clinical trials to be quiet important: social

value, scientific validity, fair subject selection, risk/benefit balance, independent review, informed consent and

elements to valid consent.

Messages I will take to my constituency: My message is that clinical trials are valuable and that more

participation is very important to the goal of eradication of cancer. The Phase O, Phase I and Phase II Trials are

well structured and each is equally as important to bring new treats to the flight in the cancer war.


on this topic)

Explain:

Additional topics:

Helen Davis Session Info: 5/30/2009 Genetic Cancer Risk Assessment and the Community 136

Education Hours credit: 1.25


Comment:

Significant findings reported: One of the major problems of genetic risk assessment, counseling and testing is the

identification of patient referrals of the high risk individuals to a program to follow up on the patient care. The

nuts and bolts to start a genetic practice: identify the client- counsel - genetic risk assessment- counseling-

genetic counselor or genetist- manage the client according to risk identified and continue to follow up. Some

advantages of the oncologist as the genetist include: the patient has continuity of care; patient may be more

familiar, comfortable and willing to be followed and the billing process is well established.

Messages I will take to my constituency: My constituency message is to become more knowledgeable of the

doctor, oncologist, mammogram technician, nurses. Primary care physicians, family practice physicians and other

physicians need to incorporate genetic risk/assessment and testing programs into their practice to enhance

patient are and to improve quality of care; preventing care; identify high risk individuals; avoid malpractice and to

provide genetic education to the patient.


on this topic)

Explain:

Additional topics: I would like to see an extensive program to educate the needed doctors and nurses in genetic

risk and assessment of cancer.



Helen Davis Session Info: 5/30/2009 Genetic Testing and Society 206 Education Hours credit: 1.25


Comment:

Significant findings reported: Ethical, screening and informed consent are interconnected in a method that I now

will be able to share more information with our community.

Messages I will take to my constituency: My message will be to incorporate more of the above information with

the underserved community in an effort to better provide informed processes. My constituency will be

encouraged that researchers and scientists are working to personalize cancer care to extend beyond cancer

treatment to risk assessment for prevention, interventions and cancer survivorship. as more and more cancer

patients become cancer survivors through more effective therapies, it is recognized that each individual is unique

in the survivorship phrase. Cancer survivorship should be personalized as cancer relates to how patient and

doctor communicate. Beyond improving cancer outcomes for patients, a personalized approach to cancer care

substantially reduce the cost of cancer on the healthcare as a whole. All of the above must take account each

individual patient has a unique social support system; comorbid illnesses; financial circumstances and education

levels.


on this topic)

Explain:

Additional topics: I wish to better verbalize the importance of ethical issues in research.

Helen Davis Session Info: 5/30/2009 Genetic Testing and Society 206 Education Hours credit: 1.25


Comment:

Significant findings reported: Ethical, screening and informed consent are interconnected in a method that I now

will be able to share more information with our community.

Messages I will take to my constituency: My message will be to incorporate more of the above information with

the underserved community in an effort to better provide informed processes.


on this topic)

Explain:

Additional topics: I wish to better verbalize the importance of ethical issues in research.



Helen Davis Session Info: 5/31/2009 New Endpoints for New Treatments 205 Education Hours credit:

1.25

Presenter1: Very good Presenter 2: Very good Presenter 3: Very good Presenter 4:

Comment:

Significant findings reported: Significant findings of this session were: clinical trials are now funded by

government 31% and industry 57%; and clinical trials are able to obtain p <0.05 by utilizing a multi center and

international collaboration. In addition the clinical benefits need to look beyond research to assess the real

benefit of treatment to real patients in the real world.

Messages I will take to my constituency: The message to my constituency is some differences between Phase 2

and Phase 3 clinical trials are: the Phase 2 trial has several designs. Some designs are: single arm; randomized;

stratified 2 x 2 Factorial Adaptive and the competitive Screening Design. The Phase 3 design is to verify

information such as dose, safety and efficacy. The purpose is for medical practice, standard of care, reduce the

number of failures and to monitor cost.


on this topic)

Explain:

Additional topics:

Helen Davis Session Info: 5/31/2009 Advances in Cancer Outcome Measurements-PROMIS 144


Presenter1: Good Presenter 2: Good Presenter 3: Good Presenter 4:

Comment: n/a

Significant findings reported: The item bank is a collection of questions linked to one thing/question/concern. A

testing example is local independence- measure range- target population. A testing example is static form-multi

stage-Computerized Adaptive Test (CAT).

Messages I will take to my constituency: There are different measures of the CAT to enhance outcomes in

research. Select the measure according: to what is available; the query of different sets of items and compare to

enhance common measures. Some of the measures include: pilot testing measures, single item measures, and

longitudinal designs.


on this topic)

Explain: n/a

Additional topics: n/a



Helen Davis Session Info: 5/31/2009 Plenary Session- Including Science of Oncology Award 0 Plenary

Hours credit: 3.00

Presenter1: Excellent Presenter 2: Very good Presenter 3: Very good Presenter 4: Excellent

Comment:

Significant findings reported: A new drug BS1-201 represents a breach in the previously impenetrable wall of the

triple negative breast cancers, which do not respond to standard therapies. The new drug BS1-201 has given

women up to 3 1/2 months. This new drug may be a hallmark for the triple negative breast cancer patients. In

the past the triple negative breast cancer patients have missed out on many recent advances in breast cancer.

Messages I will take to my constituency: BS1-201 needs further research study; however, it brings hope to the

triple negative breast cancer patients, who were not candidates for Tamoxifen, aromatase inhibitors and

Herceptin. Further research is needed.


on this topic)

Explain:

Additional topics: N/A

Helen Davis Hours credit: 11.50



Jo-Ellen De Luca Session Info: 5/29/2009 ODAC/BLA 0 Drug approval panel Hours credit: 0.00


Comment: This was a fascinating view of a newly approved drug and how it takes both FDA & Pharma to work

together.

Significant findings reported: A new drug (shortly to be named) was passed.

Messages I will take to my constituency: Our FDA is willing to work with all who adhere to efficacy and safety.

Must think of the long range (how many will die or be impaired) before rush to sentiment.


on this topic)

Explain: This is sort of out of the ASCo catalogue yet many speakers were invited to present.

Additional topics:

Jo-Ellen De Luca Session Info: 5/29/2009 Controversial Issues in Rectal Cancer panel Hours credit: 1.25


Comment: Wolmark visit a plus! Dr Paty says Local Excision Yes (by him)-NOT recommended for others!

Significant findings reported: Rectal cancer becoming more perplexing. Difficult to find positive outcomes as in

colon. Change mitonycin w/cisplatin. Working on HER2 & CRC

Messages I will take to my constituency: Chemo does better in large doses. Rectal is improved with Oxaliplatin.

Anal is Squamous:highly sensitive and difficult: 5FU/nitromycin/radiation/&hope.2Lg Trials in Italy/France lead

the way w/Oxaliplatin (rates>down with).Expensive++


Explain: genetics is a huge help.Sahia's Trial design/decision is the basis of this panel.

Additional topics: In late stage CRC can leave the primary tumor in place & go on to chemo w/out surgery. QOL

issue. Gut surgery leaves patient too disabilitated.

Jo-Ellen De Luca Session Info: 5/29/2009 Dilemmas in Management of Upper GI Symptoms panel Hours

credit: 1.25


Comment: Quite informative. We don't usually hear much on symptom management with devices or

radiotherapy included.

Significant findings reported: Preferable for local (hospital) site not to insert stents. The teaching center (MSK

here) has fail-safe measures. Locals often mess this. Difference between plastic & metal stents not to be under

rated.



Messages I will take to my constituency: Watch for these Docs (Busaidy,Lee,Milland) to come up with ways to

lower inflammatory markers-thence gi cancers.


Explain:

Additional topics: more about gastroporosis & malabsorption.While I suffer greatly from this, it appears not

much my Physicians-so how could the patient understand?

Jo-Ellen De Luca Session Info: 5/30/2009 Mentor Session panel review Hours credit: 1.25


Comment: Everyone at ASCO needs to hear these 3 women before beginning their experience.

Significant findings reported: 1st I'd heard of triple negative. VA needs to look carefully at (Retro) what we have.

Novel agents w/gastro cancers are working as much as 7 mos longer life.

Messages I will take to my constituency: Improvements in life and QOL are coming.


Explain: The everyday language of the panel made our background work applicable.

Additional topics:

Jo-Ellen De Luca Session Info: 5/30/2009 Opening session Plenary Hours credit: 2.00


Comment: CALGB Prevention: 6MP & Methotrexate in blood mentioned-it's 18 pages. This needs to be found.

neoplastic disease (dk this)

Significant findings reported: ASCO has vast influence on cancer in America. This is the time of Patient-Centered

Care.

Messages I will take to my constituency: Cancer.net has templates for colorectal cancer Survivorship. NOT

@their booth. dk what I was talking about. They should have listened to Dr Shilsky.


on this topic)

Explain: This was a terrific chapter on Dr Shilsky and Dr Neiderhuber. Truly paragons.2 1/2 hours of more than

this one year.

Additional topics: We can have our pick in genetic catalogue: breast,pancreatic,prostate. Others coming along

this decade.



Jo-Ellen De Luca Session Info: 5/30/2009 FDA-EMEA Panel Hours credit: 1.25


Comment: There were 5 Presenters. The European Drug process for approval is different in ways we may be

looking at: giving more info on the Market Letter and on the denial letter.

Significant findings reported: A warning is FDA's "Black Box" of all time. Engage more investigators. Educate

Congress.

Messages I will take to my constituency: In US: Clinical Benefits>End Points In Europe: Benefit/Risk & full

disclosure of Sponsor letter of denial


on this topic)

Explain:

Additional topics: Steps a Pharma must go through to have a potential drug accepted for a full FDA process.

Jo-Ellen De Luca Session Info: 5/31/2009 Mentoring Session panel Hours credit: 1.25


Comment: Johnson, Sudley & Gerber are all top notch. Speak well and have a wealth of info

Significant findings reported: EGF like skin/He likes lung cancer & hormone therapy 2) New product out for

treating prostate cancer therapy. 3) more on platinum

Messages I will take to my constituency: Efforts toward prostate cancer on the way. Poland has BRCA gene type;

75% complete disappearance in tumors


Explain: genes and more genes;-) gene expression.

Additional topics: Provenge-have little knowledge of men's cancers.

Jo-Ellen De Luca Session Info: 5/31/2009 Discussing Cost of Care w/Patients w/Cancer: What can we tell

them? panel Hours credit: 0.50


Comment: I went primarily to hear Dr Schnipper-a former BI Physician. Also heard Dr Emanuel. We need much

more in depth lessons on this topic

Significant findings reported: 1) ASCO recognizes rising costs. No one can afford if they have no insurance

coverage. 2)Patients disease the best if well covered. least likely to do well: those with no coverage and not

eligible for public care.

Messages I will take to my constituency: keep insurance at all costs.




Explain: We did not cover insurance costs

Additional topics:

Jo-Ellen De Luca Session Info: 5/31/2009 Posters poster Hours credit: 0.50


Comment: 5th Barely understood: #18 s-trans or trans-fuences//& I have had many esophagael survivors

Significant findings reported: Rash (using ge/erlotinab) produces better outcomes. 5FU maybe the workhorse: in

RCT it performs well as Gem/Ox

Messages I will take to my constituency: Went primarily to see Len Gunderson,Jim Martenson's work.Dr

Haller,too Radiation plays a more narrow-beam role


Explain: except #18

Additional topics: Lay out and how to avoid crowds

Jo-Ellen De Luca Session Info: 5/31/2009 Targeted Sponsors/Booths booths Hours credit: 0.50

Presenter1: Good Presenter 2: Very good Presenter 3: Excellent Presenter 4: Excellent

Comment: Genentech best bet for patient advocates. Cancer.net had no clue they produced pat/survivor

information as described in a panel.

Significant findings reported: PAF had thumb drive for medical health records. Ginger helped get me home!

Moo Cream is helping sponsor my Walk NCCS wonderful info C3 great vibe w/Carlea & Kate CCA Buddy folks

finding info on radiotherapy hard to impossible Sir Shperes good info. ASCO booth nice but not so much for Pat

Advocates

Messages I will take to my constituency: More advocates should attend ASCO. There was not as much foot traffic

as expected here


on this topic)

Explain:

Additional topics:



Jo-Ellen De Luca Session Info: 5/31/2009 Evaluating Cancer Therapies in RCTs panel Hours credit: 1.25


Comment: We need to be more aware of the Questions. RCTs provide excellent internal validity, lg databases to

track patients when turned 'loose' into the real world.

Significant findings reported: Results even today are dismal:Ph 2's+12% Ph3s=50%. Risk in patient death most

important.

Messages I will take to my constituency: 900 new drugs predicted to come w/in a decade. 5,900+CTs majority in

Phase 3.Over 43% of all NDAs to FDA are Oncology products


Explain: Genes. statistics,validity, efficacy

Additional topics:

Jo-Ellen De luca Session Info: 5/31/2009 Chemo/CTs in Frail Adults panel Hours credit: 1.25


Comment: Have to "Hunt relentlessly" to find any results on this subject.

Significant findings reported: elderly actually perform well on Trials. Start with Super healthy and work down to

more frail. give less dose and work up.

Messages I will take to my constituency: CALGB 9670 barriers to Trials/ actually physicians do not offer for

elderly to accept. Staff thinks, "too much effort"


Explain: in terms of trial design and in statistics. Much with this group will become 'boomer-ready' if we go

prospectively.

Additional topics: How to use different endpoints with this group.

Jo-Ellen De Luca Session Info: 6/1/2009 Individualizing Therapy for colorectal Cancers panel Hours

credit: 1.25


Comment: Who couldn't find an interesting panel with Grothey, Lenz & Lee??? These three super dynamos of the

GI world gave a 1-2-3 punch to today's world.

Significant findings reported: Optimize the sequence & duration of mCRC thru drugs/layering 2)establish

biomarkers to guide treatment plans & decisions in CRC 3) promising FUTURE biomarkers ont he way. don't hold

breath for this crop of patients.

Messages I will take to my constituency: Tumor size still a good predictor of survival




Explain: gene testing, KRAS, RAF

Additional topics:

Jo-Ellen De Luca Session Info: Advances in Colorectal Chemo Prevention panel Hours credit: 1.15


Comment: I don't recall any less than excellent presenters. Aspirin takes at least 10 years before bone/risk works

thru inflammatory process pathways.

Significant findings reported: 1)SPORE: his will work w/NSAIDS (celebrex,aspirin,Suldinac) 2)40% incidence of

adenomas,150,000>crc;5.6% pcp 3)says he suggests 40% risk reduction w/Suldinac in FAP TREATED melanomas:

12 were rebound

Messages I will take to my constituency: Colon Cancer is really many cancers. Maybe a dozen types.


Explain: Genetics, genes, pathways, gene expression...Each of our Pre-ASCO topics should be reviewed yearly!

Additional topics: The vocabulary moves very quickly, even in "my" territory. Adding a foreign accent thickens the

plot.

Jo-Ellen De Luca Hours credit: 14.65



Sharon Folland Session Info: 5/29/2009 Bone Health in Breast Cancer 105 Education Session Hours credit:

1.25

Presenter1: Good Presenter 2: Very good Presenter 3: Very good Presenter 4:

Comment:

Significant findings reported: Dr. H. G. Bone: Significant improvement in bone mineral density with RANKL for

breast cancer patients on aromatase inhibitors, and helps with prostate cancer patients as well.

Messages I will take to my constituency: Bone health is often an issue with older women and osteoporosis. Bone

health is often more concerning when breast cancer is added into the mix and patients are taking tamoxifen

and/or other hormone therapies including aromatase inhibitors. This advocate thinks it is good news that there

is an intervention that can help maintain or improve bone mineral density with aromatase inhibitors which could

improve quality of life with the RANKL treatment. RANKL also showed little evidence of side effects when

compared with placebo, which is encouraging as many cancer therapies cause side effects.


Explain:

Additional topics:

Sharon Folland Session Info: 5/30/2009 Research Review Session for Patient Advocates Review Session

for Advocates Hours credit: 1.00


Comment: It was interesting to hear about other tracks and the useful information coming from the many

breakout sections.

Significant findings reported: One of the comments that struck me was Dr. Gralow answering a question about

the stem cell sessions in breast cancer. She said that the information was confusing and she did not really know

how this information could be translated to the clinic.

Messages I will take to my constituency: There have been advances in non small cell lung cancer and targeting

therapy to those who will most benefit. One of the messages I heard today was that patients of childhood

cancers do not adhere to screening guidelines for other cancers. I think it is really important for survivors to keep

current with guidelines to find any other cancers that may occur at the earliest stage.


Explain:

Additional topics: If I want to know more about prostate, lung, and childhood cancers I need to research them. I

don't think we could cover different cancer types. But some of the information would be easier to understand if I

were more familiar with the differences in ca



Sharon Folland Session Info: 5/30/2009 Breast Cancer--Local, Regional, and Adjuvant Therapy 240 Oral

Abstract Session Hours credit: 2.00


Comment: There were more than 4 presenters. I did not attend the entire meeting because I went to the

Advocate Lounge Research Review Session from 5:15-6:30.

Significant findings reported: 1. Patients need to have radiation therapy to the upper axilla when there has not

been a complete lymph node dissection as in sentinel node. Patients who have micrometases in lymph nodes

need to be sure the area is irradiated to prevent or delay recurrent disease. 2. Findings from a study with

tamoxifen and CYP2D6 inhibitors support the presence of a clinically significant drug interaction between

tamoxifen and known CYP2D6 inhibitors. This resulted in a significant 1.9 fold higher Breast Cancer recurrence

within 2 years of initiating Tamoxifen therapy. 3. Final results from 10-year analysis of Chemo N0 is the first

prospective biomarker-based therapy trial in early breast cancer defining a patient group achieving good long-

term disease free survival without any adjuvant therapy. This trial demonstrates that, using a standardized

uPA/PAI-1 ELISA, about half of N0 patients, classified as low-risk, could be spared chemotherapy, while high-risk

patients benefit from adjuvant chemotherapy. These 10-year results validate the long-term prognostic and

predictive impact of uPA/PAI-1 at highest level of evidence (LOE I) and support their guideline-based routine use

for risk-adapted individualized therapy decisions in N0 breast cancer.

Messages I will take to my constituency: Patients who have sentinel node dissection may need to have radiation

therapy to prevent recurrence in the remaining lymph nodes. 2. Patients using tamoxifen may need to be taken

off of antidepressant therapy. I think this is important because often cancer patients experience depression

during treatment and may have been given CYP2D6 inhibitors which can affect the effectiveness of tamoxifen. 3.

The news that there is a biomarker that has been proven to define a patient group who can forgo chemotherapy

and define a group who can benefit from chemotherapy is very good news in the personalized medicine arena. It

is very important to treat those who can benefit and not to overtreat those at low risk.


Explain: The information about biomarkers was especially helpful.

Additional topics:

Sharon Folland Session Info: 5/30/2009 Breast Cancer Stem Cells: Characterization and Potential

Significance 230 Clinical Science Symposium Hours credit: 1.50


Comment: Although the presenters were okay at presenting the information, it did not seem that stem cells are

ready to be used in the clinical setting. These seem to be preliminary research, that may have potential to be

used in diagnostic and prognostic workups

Significant findings reported: This was not deemed significant at this point, only as a generator for further trials

to show if stem cells could be used in the management of breast cancer.

Messages I will take to my constituency: Although stem cells may be used in the future to tailor therapy to

individuals, it is still too early to see what effect this might have on diagnosis, treatment, and prognosis. There



does seem to be some promising aspects to this research, but it was rather confusing at this point as to what role

stem cells could play.


Explain:

Additional topics: What are stem cells, how are they being exploited for therapy or following disease progression.

Sharon Folland Session Info: 5/30/2009 Opening Session with Presidential Address 213 Special Session

Hours credit: 2.00


Comment: The name and history of the Karnosky Memorial Award was interesting and new to me. It was

interesting to me that the start of chemotherapy came after serving in war where mustard gas was used as a

weapon to see if mustard gas could be used as a weapon ag

Significant findings reported: One of the things I found very interesting was the NCI director's explanation of how

records are being centralized and researchers might be able to access a large patient data base to see individual

information (a cloud) that could be selected to conduct research.

Messages I will take to my constituency: My message would be that individuals may be able to put information

into the central data base at NCI and then not have to fill out information for every research project that they

might be helped by their participation. Accrual to trials is often difficult and this might be a great help in

gathering some information for certain types of trials.


Explain:

Additional topics:

Sharon Folland Session Info: 5/31/2009 Basal-like and Triple-Negative Breast Cancer 334 Clinical Science



Comment: It was very interesting and informative for me to hear the basal type and triple negative definitions

from the speakers. It will be helpful in reviewing grants. It is very good news to hear that there is progress in

treating this type of breast cancer.

Significant findings reported: The definition of triple negative as compared with basal like, some doctors see it as

the same category. The PARP inhibitor success in a second trial that treats triple negative breast cancer.

Messages I will take to my constituency: There is progress in the triple negative breast cancer treatment with the

PARP inhibitors. There is much work in this area and hope to see more treatments in the near future.


Explain:

Additional topics:



Sharon Folland Session Info: 5/31/2009 Plenary Session 333 Plenary Hours credit: 3.00


Comment: There was a lot of good information to take home for many types of cancer reported in this session. 1.

The ovarian cancer trial finding that constant monitoring of CA125 and early treatment for ovarian cancer

recurrence did not make a difference in survi

Significant findings reported: The three above things are what I would most report to my group. The ovarian

cancer trial finding that it is not beneficial to follow CA125 for earlier treatment. 2. The PARP1 inhibitor

combined with gemcitabine/carboplatin shows benefit in metastic triple negative breast cancer. 3. The NSABP

Protocol C-08 showing no benefit to adding bevacizumab to m FOLFOX6.

Messages I will take to my constituency: This are important findings to help personalize medicine to the specific

cancer types that have been researched.


Explain:

Additional topics: Different types of chemotherapy. However, I know I could find lists of the drugs by researching

on my own.

Sharon Folland Hours credit: 12.25



Valerie Fraser Session Info: 12:00:00 AM Cancer Stem Cells: Biologic and Therapeutic Targets Clinical

Science Symposium Hours credit: 1.50


Comment: All presenters in this session were wonderful, Dr. Hassan, Dr. Beer, Dr. Roodhart. Dr. Wicha was most

excellent in his detailed explanation of the relationship between cancer cells and cancer stem cells.

Significant findings reported: Cancer stem cells develop from the organ which harbors the cancer. Cancers are

driven by cells with stem cell properties. Embryonic stem cells are highly predictive of cancer. Oncogenes can be

stem cell regulation genes. There is evidence we can target some of these genes. CEC's and EPC's are increased

7-21 days after chemotherapy. CEC's and EPC's contribute to tumor vascularization. These may be an appealing

marker for anti-angiogenic therapy.

Messages I will take to my constituency: Cancer stem cells are an important area of cancer research. CEC's &

EPC's are appealing markers for anti-angiogenic therapy.


Explain: The "Genomics in Cancer" Manual was quite helpful as well as the Proteomics Webinar.

Additional topics: More information on CEC's and EPC's may have been helpful.

Valerie Fraser Session Info: 12:00:00 AM New Advances in Gynecological Cancers Clinical Science



Comment: Dr. Plummer, Dr. Matulonis and Dr. Kerbel presented some excellent research on new promising

therapies.

Significant findings reported: PARP inhibitors have great promise in BRCA 1 & 2 ovarian cancer. BIBF 1120 could

be effective in delaying time to progression in ovarian cancer targeting VEGF and angiogenesis. PARP and BIBF

1120 could be new therapies effective in the future treatment of ovarian cancer.

Messages I will take to my constituency: New therapies have shown great promise in efficacy in ovarian cancer

and studies are ongoing.



Additional topics: I'm not sure what else might have been helpful for a better understanding of this materials.

The above materials stated were very helpful.

Valerie Fraser Session Info: 12:00:00 AM Breast Cancer Stem Cells: Characterization and Potential

Significance Clinical Science Symposium Hours credit: 1.50

Presenter1: Very good Presenter 2: Excellent Presenter 3: Excellent Presenter 4: Excellent

Comment: Excellent presenters, particularly Dr. Laura Van T. Veer, Dr. Lim and Dr. Dubin.



Significant findings reported: The luminal progenitor cell may represent a target for prevention of BRCA 1 breast

cancer.

Messages I will take to my constituency: That breast cancer tumors produce stems cells which can reside in the

bone marrow. A bone marrow biopsy may provide more information to patients as to the presence of CSC, which

could be targeted for treatment in the near future.


Explain: The "Genomics in Cancer" Manual was quite helpful.

Additional topics: Some background on the relationship between cancerous tumors and the stem cells associated

therewith would have prepared me more fully.

Valerie Fraser Session Info: 12:00:00 AM Breast Cancer - Metastatic Poster Discussion Hours credit: 1.00


Comment: The speakers Ruth O'REgan; John Mackey; Nancy Lin and Maura Dickler were excellent in their

presentations of the leading research from the posters presented for metastatic breast cancer

Significant findings reported: The importance of finding appropriate targets. The suggestions of two new

predictive biomarkers. More therapies directed against the EGFR.

Messages I will take to my constituency: There is much promising research going on in metastatic breast cancer

regarding biomarkers, EGFR inhibitors, and research looking at metastatic breast cancer and brain metastasis.


Explain: The Proteomics materials and webinar were very helpful.

Additional topics: Could not identify anything in particular that stood out that I would have needed more

information or a greater understanding of.

Valerie Fraser Session Info: 12:00:00 AM Translating Translational Research Into Practice Educational

Hours credit: 1.25


Comment: Another outstanding presentation by leaders in translational research, Dr. Bast, Dr. Markman and Dr.

Bennett.

Significant findings reported: Better molecular diagnostics will diagnose disease earlier; treatment can be

personalized; translational research plays a key role; must link diagnostic testing with therapeutics; clinical

oncologists must become active participants in translational research

Messages I will take to my constituency: Translational research is cutting edge research, accelerating treatment

options to the patient.





Additional topics: More educational materials on translational research might have been helpful, but I did have a

basic understanding of the concept and theory of this new research method.

Valerie Fraser Session Info: 12:00:00 AM Personalized Cancer Therapy - Pathways to Progress Special



Comment: Both Dr. Pollack and Dr. DeHoff presented some compelling information regarding key pathways and

targets associated therewith.

Significant findings reported: IGF-1 and insulin are therapeutic targets in cancer treatments and are linked to AKT

and Kinase Pathways. There are many trials ongoing. The Hedgehog Pathways is extremely promising because it

can hit multiple targets (tumor, stroma, stem cells). A new clinical trial Battle 2 is targeting the PI-3 Kinase/AKT

Pathway.

Messages I will take to my constituency: There are extremely promising therapeutic targets now in clinical trials

that will transform the way cancer is treated in the near future.



Additional topics: Would have been helpful to more fully understand some of the pathways presented, such as

Hedgehog.

Valerie Fraser Session Info: 12:00:00 AM Special Session: NCI Director's Address; ASCO President Address;

Award Recipient Address Special Session Hours credit: 2.00


Comment: These three outstanding speakers discussed the promise of personalized medicine, history of

chemotherapy, and an acute cancer AML, now widely cureable.

Significant findings reported: Whole genome sequencing will drive all research and development of small

molecules over the next 5 years, leading to a transformation toward personalized medicine.

Messages I will take to my constituency: That much promise awaits cancer patients as we move toward

personalized medicine and targeted therapies.



Additional topics: It would have helped to have more basic science into the development of cancer.

Valerie Fraser Hours credit: 10.00



Venus Gines Session Info: 5/31/2009 The UICC Cervical Cancer Initiative: A comprehensive program for

cervical cancer prevention worldwide 1547 poster Hours credit: 0.25


Comment:

Significant findings reported: The Int'l Union Against Cancer is dedicated to the global control of cancer. The

poster presentation highlighted its UICC Cervical Cancer Fellowship program, which includes a CCI Curriculum;

training and workshops. I signed up to be a reviewer.

Messages I will take to my constituency: I want to get more involved in this program


on this topic)

Explain:

Additional topics:

Venus Gines Session Info: 5/29/2009 Fundamentals of Clinical Trial Design & Methodology 267



Comment: Not once did the speakers include the community perspective on the design and how they would

conduct CT with participants who are considered "underrepresented" in research.

Significant findings reported: Good background info on the Belmont Report, the differences in Phases of Trials;

the pro and con with placebos and finally-the lack of response to my question about community input in the

design.

Messages I will take to my constituency: 7 Criteria - Ethics


Explain: The webinar and PPT was excellent.

Additional topics: I'd like to see a topic on the steps on Developing a Research Design 101 - how does one

Venus Gines Session Info: 5/30/2009 ALTTO Study Team Roundtable Hours credit: 1.00


Comment:

Significant findings reported: NCCTG is based in Milan but its US site is at MAYO in Rochester, study design was

presented re 4 Control groups; one taking Trastuzumab only; other taking Lapatinib only; another combines both

with a 6 wk washout in between and the final would combine both Lapatinib and Trastuzumab w/o a 6wk

washout. This would be for 52 wks. As they described their earnest efforts to recruit members of racial/ethnic

minorities, I question that their recruitment materials were not available to review in Spanish. I did not receive



the toolkit as requested. As a reviewer, I provided some feedback on recruiting Latinos, which included the health

fiestas and Promotoras de Salud. Overall the Roundtable was good.

Messages I will take to my constituency: There is a cautionary note here, especially when foreign drug

manufacturers want to launch a clinical trial in this country and there is very little relationship established with

community-based organizations.


on this topic)

Explain:

Additional topics:

Venus Gines Session Info: 5/30/2009 International Cancer Outcome Disparity:What Do We Owe our

International colleagues 151 Education Session Hours credit: 1.25

Presenter1: Very good Presenter 2: Excellent Presenter 3: Very good Presenter 4: Very good

Comment: Incredible insights on what is happening outside of the US

Significant findings reported: St.Jude's dedication to the children of the world was the best in this panel. They

shared their incredible success but was sorry to see how much they have suffered, especially with this economic

downturn.

Messages I will take to my constituency: St Jude is not just for white children, it is committed to save the lives of

all children, including immigrant children.


on this topic)

Explain:


Venus Gines Session Info: 5/30/2009 A novel copay foundation assistance support program for patients

receiving cancer therapy in cancer centers 6630 poster Hours credit: 0.25


Comment:

Significant findings reported: A private cancer center with 10 physicians hired a patient care staff person to

facilitate grant requests to provide copayments for underserved and needy patients. The ROI for the center was

positive as the foundations were willing to provide the funding based on the structured requests for assistance

and the process established for patient support. One major finding was that the foundations wanted to give

more than was needed for the co-pay support—generally funding requests at $5000-$6000 when the average

patient co-pay expense was more in the range of $1300-$1500. This actually caused a bottleneck in the funding

process as the physician group wanted to return the money and there was no process for pooling the excess

funds to help patients more rapidly. After our conversation the researcher plans to look at the data to determine

how many of the patients who received co-pays considered.



Messages I will take to my constituency: when writing grants, it is OK to add copay support on the budget.


Explain:

Additional topics:

Venus Gines Session Info: 5/30/2009 Clinical Benefit in Oncology Trials: Is this a patient centered or

tumor centered endpoint 0 poster Hours credit: 0.25


Comment:

Significant findings reported: Most clinical trial designs have endpoints that are tumor centered and do not

consider patient clinical benefit. The presenters suggest a that endpoints in trial design need to be significantly

re-considered to focus more on the patient benefit, still from a scientific viewpoint.

Messages I will take to my constituency: Patients and Navigators need to be knowledgeable about what

endpoints are in trials and what they mean to both the patient and the drug development process. If the

endpoints don’t make sense or seem out of sync with the patient benefits, the site and the IRB should be

provided feedback and suggestions for positive change to expect trial designs with more patient focused

endpoints


Explain:

Additional topics:

Venus Gines Session Info: 5/30/2009 Patient and Health System Disparities in timeliness of treatment

for individuals with colorectal cancer (CRC) 0 poster Hours credit: 0.25


Comment: Very good speakers

Significant findings reported: The main indicator of timeliness was inpatient vs. outpatient care, with the

evidence showing that inpatient care of CRC is more timely. The assumption and follow on interviews with

physicians indicated that the element of timeliness in inpatient care is may be a factor of multidisciplinary clinics.

The data was retrospective analysis using SEER data so some of the indicators such as Socio-Economic status were

developed as proxies using county census tract data. Thus the rigor of the SES analysis was relatively weak.

However, the hypothesis that rural patients would have less timely care than urban was not borne out. Racial

and Ethnic factors were also not significant. The findings did not support many commonly held assumptions.

Additional observational research is suggested by the presenters

Messages I will take to my constituency: Where patients are treated does matter. When possible, patients

should seek clinics and physician groups that practice using a multidisciplinary model.




Explain:

Additional topics: More facts on colorectal cancer.

Venus Gines Session Info: 5/30/2009 Breast Cancer Patients’ Quality of Care: Does Racial Concordance

matter or is it a matter of trust. 0 poster Hours credit: 0.25


Comment: Very interesting

Significant findings reported: Patient trust is important and patients and their families and care advocates need

to be proactive in seeking dialogue with their physicians and other healthcare professionals. Patients should

expect to feel trust in their physicians. While linguistic competency is important for non-English speakers, cultural

humility and respect are critical components of care and patients have a right to expect an open and trusting

relationship with their healthcare providers

Messages I will take to my constituency: We need more research on the root of the mistrust that affects

someone's quality of Care.


Explain:

Additional topics: Medical abuse should be a topic for all researchers.

Venus Gines Session Info: 5/30/2009 Crossing the 3% Barrier: Improving Accrual and Access in Clinical

Trials 159 Education Session Hours credit: 1.25

Presenter1: Good Presenter 2: Good Presenter 3: Good Presenter 4: Good

Comment: These speakers were good but I did not hear any strategies on improving recruitment and retention of

racial/ethnic participants in clinical trial.

Significant findings reported: The physician factor needs to be explored. The speakers spoke about the barriers

for the participant but did not expand on the barriers of the physician. They stated that the complaints from

physicians stem from "no time" to "no institutional incentive"

Messages I will take to my constituency: Barriers to clinical trials will not be eliminated unless there is a

concerted effort to educate the physicians.



Additional topics: Educational toolkit for Physicians to learn about Clinical Trials- that would answer their

concerns.

Venus Gines



Session Info: 5/30/2009 Bringing God to the bedside: Addressing the Diverse Spirituality &

Religious Experience of Patients and Cancer 102 Education Session Hours credit: 1.25


Comment: This was a great session, but more importantly, we learned during the Q&A)from a couple of doctors

who complained about the time it would take to converse with their PT about religion.

Significant findings reported: Survey was conducted to find out if physicians talk to their patients about their

spiritual needs and the results were amazing. Physicians tend to be less religious. Americans are more religious,

believe in the healing power of prayer, heaven and the capacity of faith to help in their recovery from disease.

Messages I will take to my constituency: Perhaps we should not expect our doctors to talk to us about religion

and spirituality. We, as patients, should initiate the discussion and decide if they are sincere in their response. I'd

like to develop talking points as to how to discuss God with your doctor.



Additional topics: Develop a guide for advocates to discuss Religion and Healing.

Venus Gines Session Info: 5/31/2009 Training Program Directors Special Session: How to be a Program

Director 220 Special Session Hours credit: 2.00

Presenter1: Way over my head Presenter 2: Way over my head Presenter 3: Way over my head

Presenter 4: Way over my head

Comment:

Significant findings reported: I actually thought this session was going to be about how to be a Program Director-

wrong. I was already seated in the middle of the room when the first speaker began presenting on this topic for

PD in Medical Institutions. I was too embarrassed to get up and walk away,esp after the long hike to get there. I

stayed and did learn a few things but unfortunately, it was way over my head.

Messages I will take to my constituency: Although this was more geared toward PD -supervision of fellows, I still

enjoy some ideas for the future.


on this topic)

Explain:

Additional topics:

Venus Gines Session Info: 5/31/2009 HPV Vaccines 185 Education Session Hours credit: 1.25


Comment: Great but left me wanting to know about the gaps.

Significant findings reported: I was surprised to hear that Australia has begun to give the vaccine to boys due to

the high # of men with penile cancer. I actually got up and asked a question about what doctors felt about the



vaccine in Europe now that many of the Latino doctors are totally against recommending it to their female

patients or their daughters. I was disappointed that no one would answer the question, however, after the

session, I had 4 inquiries about the results of my medical mistrust survey, one in particular was MERCK.

Messages I will take to my constituency: They won't give this vaccine to boys in this country and there is no

credible science for me to recommend this vaccine to Latina patients.


on this topic)

Explain:


Venus Gines Session Info: 6/1/2009 Keys to Speaker Success 1.25 Education Session Hours credit: 1.25


Comment:

Significant findings reported: Learned the principals of public speaking, how to stay focus and on target. Enjoyed

the 15 Min of Fame the best.

Messages I will take to my constituency: Tips on how to talk with authority.


on this topic)

Explain:


Venus Gines Hours credit: 12.75



Jody Gunn Session Info: 5/29/2009 Fundamentals of Clinical Trial Design and Methodology



Comment: 6 speakers total.

Significant findings reported: Key takeaways for me: - Two significant statistical issues in clinical trials are effect

of chance and effect of bias, these are controlled by having adequate numbers of patients in the study and using

randomization for treatment assignment, respectively. - Observational (non-randomized) studies typically used in

phase 1 and 2 trials, randomized trials phase 3. - Trends over time in diagnostic methods can make comparisons

over time difficult or invalid. - Randomized phase 3 trials best source of info concerning relative effects of

competing treatments. - Clinical trials test research hypotheses. - Terms: Type 1 error = reject hypothesis when

it is true Alpha = probability of type 1 error (level of significance) Type 2 error = accept hypothesis when it is not

true. Beta = probability of type 2 error Power = 1-beta N = sample size K = imbalance in size of groups Delta =

effect size (difference and expected variability -Clinical research is those activities designed to contribute to

general knowledge, clinical practice is interventions designed to enhance the well being of an individual patient.

This can result in dual conflicting allegiance for clinician-investigators. - Seven criteria for ethical research: Social

value – must ask an important question, scientific validity – methods must result in valid results, fair subject

selection – don’t take advantage of or exclude vulnerable or underrepresented groups, reasonable balance of

risks and benefits, independent review, informed consent, respect for enrolled subjects - Purpose of clinical trial

is to conduct research not to administer treatment although participant probably will receive good clinical care. -

Phase 0 Trial: First-in-human, low dose, limited duration, one course, no therapeutic intent, determines whether

effect can be seen in humans, improves efficiency of later trials - Phase 1 Trial: (safety, dosage range, side

effects): Identifies dose-limiting toxicities (DLT), maximum tolerated dose (MTD), assesses drug metabolism and

clearance, assesses endpoints. For targeted agents goal is to identify Biologically Effective Dose (BED). Gateway

for the clinical development of most new cancer therapies Subjects usually have incurable cancer, participants

likely to get suboptimal doses, low overall response rates, participants likely not worse off than if didn’t enroll. -

Phase 2 Trial (efficacy and safety): Assess preliminary evidence of efficacy. Provide a go/no decision for

subsequent testing. Characterized by high negative value, low positive predictive value, low percent progress to

phase 3. Single arm or randomized. Require honesty about likelihood and uncertainty of benefit versus other

treatment options - Phase 3 Trial (effectiveness, side effects, compare to commonly used treatments, safety) :

Need to address question of how investigator can ethically offer a patient random assignment. Informed consent

key, if risks are modest adults can consent to those risks.

Messages I will take to my constituency: This was a general overview that gave me a better understanding of the

trial process that should allow me to better understand research results reported elsewhere at the conference

and to better understand requests for participation in clinical trials that are targeted at the high risk community

that I represent.


Explain:

Additional topics:

Jody Gunn



Session Info: 5/29/2009 Sentinel Node Biopsy in Early-stage Breast Cancer: Recent

Progress and Remaining Challenges Education Session Hours credit: 1.25

Presenter1: Very good Presenter 2: Very good Presenter 3: Very good Presenter 4: N/A

Comment: I already had some background in the use of Sentinel Node Biopsy (SNB) for detection of whether

breast cancer has spread which facilitated my understanding of this session.

Significant findings reported: 1) SNB results 95% accurate for detecting spread of breast cancer for those

diagnosed with early-stage breast cancer. 2) Subsequent Axillary Lymph Node Dissection standard of care for

patients with positive SNB. 3) Most clinicians satisfied with SNB, however randomized clinical tests are needed to

determine therapeutic impact and long-term outcomes. 4)SNB can be done after mastectomy in some instances.

Small numbers of cases over the past ten years have a success rate of 13 out of 20. Accuracy of mapping though

is undefined. 5) SNB with DCIS is controversial however trend is towards SNB instead of ALND.

Messages I will take to my constituency: 1) Latest research on SNB as a diagnostic tool to determine spread of

early-stage breast cancer affirms that this procedure is largely accurate. 2) SNB may be possible after

mastectomy in some instances. Small numbers of cases over the past ten years have a success rate of 13 out of

20. Accuracy of mapping though is undefined. 3) No studies reported on necessity of SNB for prophylactic

mastectomy for high risk patients without breast cancer.


on this topic)

Explain: For the most part the written materials and lectures did not cover this area (diagnostic procedures).

Additional topics:

Jody Gunn Session Info: 5/30/2009 Basal-like and Triple-Negative Breast Cancer: Definition and

Therapeutic Insights Clinical Science Symposium Hours credit: 1.50

Presenter1: Good Presenter 2: Barely understood Presenter 3: Barely understood Presenter 4:

Good

Comment:

Significant findings reported: Questions to be answered: • Can chemo-responsive vs. nonresponsive cancer be

identified? • Is there evidence for platinum sensitivity in BRCA+? • Role of PARP inhibitors in BRCA1-

dysfunction? Basal-like characteristics: • Low ER, low Her2, usually triple negative, often p53 mutant, very

proliferative (fast dividing), evidence of genomic instability • Risk factors: young, African-American,

BRCA1 • Relapse pattern: higher risk, early, CNS spread 46% of time • Contrary to common belief, often

responsive to standard chemotherapy, those with non-response have poor outcome • Most BRCA1 carriers get

basal-like cancer • Most basal-like cancers are not in BRCA1 carriers (assume BRCA1 pathway dysfunction)

• Is BRCA1 dysfunction the Achilles’’ heel of TN BC? • Olaparib • Olaparib trials if first report of a

targeted therapy designed for BRCA carriers with • Response rate 41%, PFS of 5.7 months among heavily pre-

treated carriers with advanced BC • Oral olaparib well tolerated in carriers and non-carriers • Clinical

proof of concept for targeting BRCA mutations in BC and OVCA • BRCA carrier advocacy community (Facing

Our Risk of Cancer Empowered – FORCE) and Susan G. Komen made testing possible. Neoadjuvant therapy with

cisplatiinum BRCA1 BC patients (note: Narod contributor, International Hereditary Cancer Center, Pomeranian

Medical University, Szczecin, Poland) • Neoadjuvant chemo used to: control disease, make surgical resection



possible, increase possibility of breast tissue conservation, help asses chemo-sensitivity to a particular agent •

From preclinical studies know: BRCA1 BC cell lines resistant to taxanes, sensitive to cisplatinum • Pilot

study: “Response to neoadjuvant therapy with Cisplatin in BRCA-1 positive breast cancer patients” (Byrski et al.)

• BRCA1-associated cancers share molecular and phenotypic features with sporadic triple negative BC •

Cisplatin as preoperative therapy for patients with BRCA1 mutations: high response rate, •

Conclusions: Platinum-based chemotherapy effective in high proportion of patients with BRCA1-

associated BC. Choice of BC treatment may be better with BRCA1 testing. • Summary: o Cisplatin for

BRCA1-associated and TN BC looks promising, needs further study in randomized trials o PARP inhibitors

likely be a major advance, badly need serials and associated correlative studies

Messages I will take to my constituency: • Cisplatin for BRCA1-associated and TN BC looks promising, needs

further study in randomized trials • PARP inhibitors likely be a major advance, badly need trials and

associated correlative studies • Cancer advocacy groups such as FORCE helpful in recruiting patients to clinical

trials


Explain:

Additional topics:

Jody Gunn Session Info: 5/30/2009 Bringing God to the Bedside: Addressing the Diverse Spiritual and

Religious Experience of Patients with Cancer Education Hours credit: 1.25


Comment:

Significant findings reported: Patients have beliefs which shape their requests for care. • Doctors need to

respond and support patients in desperate situations where the emphasis is on what really matters to the

patient. • Enlist a “cultural broker” where necessary. • Doctors should assume a patient’s belief is

rational • Don’t assume meaning of a term or concept (“miracle”, “G_d’s will”). • Respect patient’s

belief. • Understand that religion is more than reason. It involves faith and feeling. • Doctor should be

sensitive, nonjudgmental, and not proselytizing.

Messages I will take to my constituency: Medical community beginning to grapple with the effect of religion and

spirituality on patient well being and outcome.


on this topic)

Explain:

Additional topics:

Jody Gunn Session Info: 5/30/2009 Plenary Plenary Hours credit: 3.00


Comment:



Significant findings reported: Rustin: • Genome of 68 tumors analyzed to date (including 11 breast cancers) •

Lots of mutations, only a fraction are “drivers” • Can simplify by focusing on “pathways” rather than

individual genes • Challenges: Distinguishing drivers from passengers, pathway definition, translating the

knowledge Karlan: • Recommend less frequent monitoring of CA125 levels in asymptomatic patients. •

Consider delaying palliative OVCA chemotherapy until clinical reoccurrence. O’Shaughnessy: • Report

out on phase 2 study results of BSI-201 PARP inhibitor in combination with Gemcitabine/Carboplatin in triple neg

metastic breast cancer • BSI-201 plus gemcitabine/carboplatin well tolerated, did not increase toxicity from

chemotherapy alone • Improved patients’ clinical outcomes (6.9 mos versus 3.3 mos PFS, 9.2 mos vs. 5.7 mos

OS • Promising safety and efficacy data from this phase 2 study justify further investigation of BSI-201 in a

Phase 3 study. Study to begin June 2009. Wolmark: • Phase 3 trial assessing bevacizumab in stage 2/3

colon cancer: appears to be benefit in DFS for the one year of the trial, need longer duration trial testing to

determine longer term benefits Ellis: • Against continued testing of bevacizumab. No increase in cure rate so

assume must be continued for a very period of time to show any benefit. Should not administer potent drug such

as bevacizumab indefinitely where 90 – 95% of patients will not benefit. Badly need a predictive biomarker of

Bev activity. Must follow trial patients for toxicity

Messages I will take to my constituency: From Cancer.ne (which summarizes this better than I can): In two

separate studies, researchers found that two new drugs belonging to a group of drugs called PARP inhibitors may

help treat some types of breast cancer. PARP inhibitors stop cancer cells from repairing damage from

chemotherapy, which may make cancer cells more sensitive to chemotherapy. These studies include: * The

use of a PARP inhibitor called BSI-201 to treat triple-negative breast cancer that has spread to other parts of the

body. Triple-negative breast cancer cannot be treated with hormone therapy or drugs that block HER2 (a protein

found on some types of breast cancers). This study showed that women with this type of breast cancer who

received BSI-201 and chemotherapy lived about four months longer than women who received only

chemotherapy. In addition, the time it took for the cancer to grow and spread was also more than four months

longer for women who received BSI-201 and chemotherapy. Women who received BSI-201 were four times more

likely to have their tumors stop growing or shrink than women who did not receive the drug. * The use of a

PARP inhibitor, called olaparib, to treat persistent, advanced breast cancer with mutated (changed) BRCA genes.

This study showed olaparib slowed tumor growth for 40% of patients who received the drug. What this means

for patients These studies show that PARP inhibitors may be a new type of chemotherapy that could be used to

treat breast cancer, particularly those that are difficult to treat. However, more research is needed to find out

how they can be best used to treat breast cancer. Patients who received BSI-201 had few side effects. The most

common side effects for olaparib were mild fatigue, nausea, and vomiting. These drugs are not available outside

of a clinical trial


Explain:

Additional topics:

Jody Gunn Session Info: 5/30/2009 Magnetic Resonance Imaging quantification of breast density in

BRCA carriers following gonadotropin releasing hormone against (GnRHA)-based hormonal

chemoprevention. 0 Oral Abstract - Discussion Hours credit: 0.25




Comment:

Significant findings reported: • Mammographic breast density strong marker for breast cancer risk • High

density associated with a four to six time increased risk in BC. • MRI successfully used to quantify breast

density. • Changes in breast density significant after ten months chemo-prevention treatment . • Density

as a risk biomarker can be manipulated with hormonal chemoprevention. • MRI could be used to further

measure chemoprevention effects in high-risk populations.

Messages I will take to my constituency: • Density as a risk biomarker can be manipulated with hormonal

chemoprevention.


on this topic)

Explain:

Additional topics:

Jody Gunn Session Info: 5/30/2009 Magnetic Resonance Imaging quantification of breast density in

BRCA carriers following gonadotropin releasing hormone against (GnRHA)-based hormonal

chemoprevention. 0 Oral Abstract - Discussion Hours credit: 0.25


Comment:

Significant findings reported: • Mammographic breast density strong marker for breast cancer risk • High

density associated with a four to six time increased risk in BC. • MRI successfully used to quantify breast

density. • Changes in breast density significant after ten months chemo-prevention treatment . • Density

as a risk biomarker can be manipulated with hormonal chemoprevention. • MRI could be used to further

measure chemoprevention effects in high-risk populations.

Messages I will take to my constituency: • Density as a risk biomarker can be manipulated with hormonal

chemoprevention.


on this topic)

Explain:

Additional topics:

Jody Gunn Session Info: 5/30/2009 Advances in Phase II Breast Cancer Chemoprevention Trials:

Focusing on Biomarkers Oral Abstract - Discussion Hours credit: 0.25

Presenter1: Barely understood Presenter 2: Presenter 3: Presenter 4:

Comment:

Significant findings reported: • Results from various SERM (tamoxifen, raloxifene, lasofoxifene) trials show

ability to reduce BC incidence in at risk women by 32 to 74% • No reduction in incidence or ER-negative BC



in these trials • Proliferation markers (Ki-67 by IHC and cyclin D1RNA) and breast density markers (by MG or MRI)

are potentially useful biomarkers

Messages I will take to my constituency: More study needed on biomarkers for BC.


Explain:

Additional topics:

Jody Gunn Session Info: 5/30/2009 Clinical Updates in Ovarian Cancer: Basic 101 and Beyond


Presenter1: Good Presenter 2: Barely understood Presenter 3: Good Presenter 4:

Comment:

Significant findings reported: • Randomized clinical trials on interval debulking for ovarian/peritoneal cancers.

• Factors that influence outcome: age, performance cue status, FIGO stage, ascites, grade 2/3 v s. 1,

residual tumor • Patients who are acceptable surgical candidates should undergo primary cytoreductive

surgery with maximal surgical effort • Surgery should be performed at centers with expertise •

Neoadjuvant chemo can be given first to advanced age patients and patients with poor performance

status to decrease morbidity • Patients who have not had maximal attempt at cytoreduction with initial

surgery may benefit from interval debulking if they have a response to chemo. • Chemo recommendations

for early stage OVCA patients: o No adjuvant chemotherapy: stage 1A,1B grade 1 and 2 o Adjuvant

chemotherapy: sate 1A, 1B grade 3, stage 1C, clear cell; stage 2 • Gene expression profiling in OVCA: o

Aids diagnosis of histological “look-alikes o Provides prognostic info (early relapse, long term survival o

Predicts tumor response to therapy • On the horizon: o Personalizing cancer care based on

genetic abnormalities of critical cellular pathways & genetic factors in the individual and in the tumor that

influence drug response o Need more clinical trials for initial evaluation of tumor with biopsy and imaging,

repeated biopsies for further evaluation, repeated imaging to look at early response

Messages I will take to my constituency: • Personalized cancer diagnosis and care an important emerging area.

• Need to support clinical trials.


Explain:

Additional topics:

Jody Gunn Session Info: 6/1/2009 The Majority of Locally Advanced Breast Cancer in the I-SPY TRIAL

Come to Clinical Attention in the Interval Between Routine Screening 0 Oral Abstract -

Discussion Hours credit: 0.25


Comment:



Significant findings reported: • 84% of locally advanced breast cancers presented as interval cancers •

Majority are early interval cancers (clinical mass within 1 year) • Majority of interval Cancers not

occult • Biology of Interval Cancers: large, high-grade, ER negative, fast growing • Implications o

Annual mammography not the solution to rapidly growing, locally advance breast cancer o

Heightened awareness of a growing breast mass, regardless of a recent normal mammogram o New

strategies for prevention and early detection needed, requires a better understanding of biology of locally

advanced BC

Messages I will take to my constituency: • Heightened awareness of a growing breast mass, regardless of a

recent normal mammogram


on this topic)

Explain:

Additional topics:

Jody Gunn Session Info: 6/1/2009 New Biologic and Therapeutic Insights from Hereditary Cancers /

An Educational Overview of PARP Inhibitors in BRCA Carriers Education Hours credit: 1.00

Presenter1: Good Presenter 2: Good Presenter 3: Presenter 4:

Comment:

Significant findings reported: Education session: • PARP Inhibitors are a new therapy in phase 1 clinical trials

show promising results for BRCA carriers with hard to treat cancers. • PARP = Poly (ADP-ribose)

polymerase o Key regulator of DNA damage repair process, binds to directly to DNA damage, attracts and

assists BER (base-excision repair) effectors o A number of successful pre-clinical trial proof of concept

results (Kudos/AZ, Pfizer AG14361 o Takes advantage of a BRCA tumor’s DNA repair weakness. o Olaparib

– phase 1 trials for ovarian cancer treatment found significant PARP inhibition and tumor response, most

common toxicities are nausea and fatigue o Interim review of efficacy in proof of concept phase 2 study

show tumor shrinkage with an average progression free survival of 5.7 months at the highest dose. o Seven

active PARP inhibitor trials for BRCA carriers. o Two active PARP inhibitor trials for Triple Negative breast

Cancer (BSI-201 and Olaparib). o BSI-201 results show a 9.2 month overall survival rate (compare to 5.7 months

on Gem/Carbo treatment), i.e., women with hard-to-treat "triple-negative" breast cancer who received the PARP

inhibitor BSI-201 along with conventional chemotherapy had better outcomes than women who received

chemotherapy alone

Messages I will take to my constituency: • PARP inhibitors very promising new class of drugs • Clear proof of

concept of single agent synthetic lethal approach in BRCA breast and ovarian cancers • Innovative approach to

regulatory approval trials required • Exciting possibilities for investigating hormone receptor (triple neg)

deficient tumor types.


Explain:

Additional topics:



Jody Gunn Hours credit: 12.00



Bonnie Hirschhorn Session Info: 5/29/2009 Fundamentals of Clinical Trial Design & Methodology 267


Presenter1: Excellent Presenter 2: Good Presenter 3: Barely understood Presenter 4: Excellent

Comment: Comment: Clinical Trials Issues/Design; Rationale for Randomized Trials, Statistical Principles in Clinical

Trials, Ethics in Cancer Clinical Research; Practical Considerations in Clinical Trial Design

Significant findings reported: : Clinical Trials (from Phase 0 to Phase III) are to be seen as a process with one

phase leading rationally and logically to the next always with the best interest of the treatment of the patient

paramount and according to guidelines established by protocols. The 7 criteria for following ethical guides must

always be paramount in establishing clinical trials and randomization should not be “influenced” by what the

researcher wants to find, but by what the findings discover.

Messages I will take to my constituency: : Clinical trials are very important to the advancement of science and

treatment of cancer patients. Participating in a trial must never be done to please your clinician or anyone else.

Always understand the entire process and ask questions until you understand each and every aspect of the trial

and what you could expect to “gain” from participating.


Explain: I felt well prepared for attendance in this session

Additional topics: I felt well prepared for this session, with the exception of the statistics. This part of the

presentation was “way over my head.”

Bonnie Hirschhorn Session Info: 5/29/2009 Sentinel Node Biopsy in Early Stage B.C. 101 Education Hours credit:

1.00


Comment: Presenters spoke to the current recommendations, guidelines and management of patients

undergoing sentinel node biopsy

Significant findings reported: : Noted that the patient with positive sentinel node biopsy would likely get full

ALND; DCIS patients with mastectomy and immediate reconstruction would not get ALND; patients with future

reconstruction would be likely to get ALND; older and obese patients have no contraindication for SNB.

Messages I will take to my constituency: : + Sentinel Node biopsy will likely result in a AND in Stage 1 and 2 BC;

chemo and/or radiation before or after the AND would not likely have a different result with regard to residual

disease.


Explain: This topic was not covered in the materials

Additional topics: Understanding false positive and false negative "readings" in the pathology lab and the

consequences thereof; when to ask: "do I trust these results" and what is to be done.

Bonnie Hirschhorn



Session Info: 5/30/2009 Mentor's Session: ASCO Panelists Education Hours credit: 1.15


Comment: Presenters: 1=Cooke; 2-Gralow; 3-Obel

Significant findings reported: Presenter offered a summary of many sessions of the day. Dr. Obel discussed GI

malignancies and spoke about phase III trials for early stage colon cancer and the effect of drug interventions on

survival when stopped. Rectal and anal cancers were also discussed. Dr. Cooke discussed the findings regarding

Lung cancer and the implications of staging for small cell lung cancer (much like breast cancer). Dr. Gralow spoke

about breast cancer - sentinel node and axillary node dissections – Tamoxifen and aromatase inhibitors and the

effects of anti depressants.

Messages I will take to my constituency: there is new information and treatment for cancer happening everyday.

Diagnosis is not a death sentence. Have hope.


Explain: Materials were not covered in readings

Additional topics: A “dictionary” of terms (drug names and their utility)

Bonnie Hirschhorn Session Info: 5/30/2009 Genetic Cancer Risk Assessment within the Community Oncology

Practice: opportunities, Pitfalls and Resources for Program Dev. 136 Education Hours credit:

1.15

Presenter1: Excellent Presenter 2: Very good Presenter 3: Excellent Presenter 4:

Comment: presenters: 1-Malvey Chair/2 - Geiger 3-Weitzel

Significant findings reported: Hereditary Cancer Syndrome is reflected in breast, colon and ovarian cancers.

Genetic counseling can assist families to “deal” with this information. Genetic Risk Assessment recognizes

patterns in 4 generation studies but patients need instructions on what/who to ask. Genetic risk is a point in time

and varies over a lifetime as new information comes about. The designated “expert” in a practice can be the

physician and/or physician’s assistant/nurse practitioner or genetic counselor.

Messages I will take to my constituency: When seeking genetic counseling determine if an academic setting or

private physician will be preferred; if using a physician’s office, determine if it will be the physician (the expert) or

a counselor or other designated person in the practice.


Explain: Written materials did not cover this topic

Additional topics: Material was adequately covered by the presenters.

Bonnie Hirschhorn Session Info: 5/30/2009 Health Services Research/Employment status among low income

Caucasian and Latina breast cancer survivors 0 Poster Hours credit: 0.20


Comment: Presenter: Victoria Blinder



Significant findings reported: Caucasian and Latina women with the same (low) income level are diagnosed with

and treated for breast cancer. After 6 months, 49% of the Caucasians employed and 27% of the Latinas are

employed. After 18 months 59% of Caucasians v 45% of Latinas are employed. 36 months after treatment there

is no statistical difference in employment. Findings suggest that the differences rest in a number of factors: type

of labor (manual v. less physically challenging), children in the home, place of birth, acculturation, English

language ability, education, and employers’ needs

Messages I will take to my constituency: Even when all things appear to be equal, they are not.


Explain: Material not covered in readings

Additional topics: More readings/discussions on disparities and how they can be overcome.

Bonnie Hirschhorn Session Info: 5/30/2009 Health Services Research/Breast Cancer Patient’s perceived

quality of care: The importance of trust and communication 0 Poster Hours credit: 0.15


Comment: Presenter Rebecca Franco

Significant findings reported: : African American women have less trust in the physicians than other women. The

physician’s perceived inability to communicate with the patient led to this lack of trust. The perception became

the patient’s reality.

Messages I will take to my constituency: : Trust is built on communication; communication must be a two-way

street. Speak up for yourself and be certain that you are heard and that you hear as well.


Explain: Course readings did not cover this material

Additional topics: Patient/doctor communication; practicum on ways to communicate more effectively.

Bonnie Hirschhorn Session Info: 5/30/2009 Health Services Research/Racial differences in the use of

contralateral prophylactic mastectomy among women undergoing BRCA1/BRCA2 genetic

testing 0 Poster Hours credit: 0.20


Comment: Presenter Kayleene Ready

Significant findings reported: African-American women are less likely to undergo mastectomy than Caucasian or

Latina women with the same information. This was a retrospective study and did not have any conclusions as to

why there was a difference in outcomes

Messages I will take to my constituency: : Information and health care are available to all; all do not take the

same advantage of their opportunities. Disparities appear and need to be understood from the point of view of

the patient to understand why there is a difference in taking advantage of opportunities for treatment.




Explain: The materials did not cover this topic

Additional topics: More information on the “sociology” of disparities.

Bonnie Hirschhorn Session Info: 5/30/2009 Coalition of Cancer Cooperative Groups 0 Exhibitor Hours credit:

0.15

Presenter1: Excellent Presenter 2: Presenter 3: Presenter 4:

Comment: Spoke with presenters about finding clinical trials - how would I know who they are. We googled

clinical trials + cancer and found their site; navigated and dissected the home page; found it difficult to find the

"search" link; noted that ethnic categorie

Significant findings reported: see above

Messages I will take to my constituency: searching for information could be difficult, do not despair


Explain: This material was not covered in course work


Bonnie Hirschhorn Session Info: 5/30/2009 Patient Advocate Foundation 0 Exhibitor Hours credit: 0.15


Comment: Met with advocates regarding advocacy outreach efforts for people in "denial" and how distribution of

materials in a variety of languages and locations in diverse communities could enhance their efforts to provide

services to under-insured, underserved po

Significant findings reported: outreach in communities of non-English speakers is weak; more outreach in many

languages is needed to assist patients who do not return for care after diagnosis

Messages I will take to my constituency: Listen for and hear the voices of people who may be crying out for help

in a language different from your own


Explain: not covered in course materials


Bonnie Hirschhorn Session Info: 5/30/2009 Exhibitor: Susan G Komen for the Cure 0 exhibitor Hours credit:

0.15




Comment: Met with representative, Kendall Bergman, and advanced advocacy for Jordanian breast cancer

program looking to establish a co-survivor program; contacted Susan Brown at Komen/Dallas who is going to

Jordan on June 1, 2009. Susan will contact Suzan Morad a

Significant findings reported: n/a

Messages I will take to my constituency: outreach and networking WORK


Explain: n/a


Bonnie Hirschhorn Session Info: 5/30/2009 Breast Cancer: Metastatic/A specific nomogram to predict

subsequent brain metastasis in metastatic triple negative BC pts 0 Poster Hours credit: 0.15


Comment: Dr. N. Ibrahim presented

Significant findings reported: It is predicted that giving radiation prophylactically will prevent brain metastases in

25% TNBC patients.

Messages I will take to my constituency: not certain as I was unable to follow the math and Dr. Ibrahim said that

his colleague did the math and could not explain the statistics.


Explain: this topic was not covered in the course work

Additional topics: certain as I was not able to ‘digest’ the topic

Bonnie Hirschhorn Session Info: 5/30/2009 Breast Cancer Metastatic/Off-label drug use in women with breast

cancer 0 Poster Hours credit: 0.15


Comment: : Wendy Dean Colomb presented

Significant findings reported: retrospective study of 65-80 year old medicare seniors to determine if off label

drugs were effective in treating metastatic breast cancer. Stage 4, tumor grade, size, ER status, node designation

were inclusive; findings that off-label drugs work but since it was retrospective study did not have information as

to whether drugs were given before or after standard of care.

Messages I will take to my constituency: Do not participate in a study unless you are aware of all of the

complexities of the trial, get fully informed consent and ask many questions


Explain: this topic was not covered in my materials

Additional topics: More information on consent/off-label drugs as trial and the testing of older adults with

questionable pharmacology.



Bonnie Hirschhorn Session Info: 5/30/2009 Genetic Testing and Society 124 Education Hours credit: 1.25


Comment: Hampel: Lynch Syndrome from population screening to practice Offit: Genomic screening for cancer:

predictive or Premature Bradbury: chair, Informed consent for Genetic Testing I asked the question of the panel

regarding "generic consent vs. informed co

Significant findings reported: Types of consent for genetic testing took over from the topic: Lynch Syndrome.

Lynch Syndrome screening described as cost effective and life saving; consensus was to screen everyone and then

utilize best practices to treat and/or monitor family member(s) as needed.

Messages I will take to my constituency: SCREEN!!!!! for Lynch Syndrome; it can manifest in a number of cancers

(colon, endometrial, ovarian, etc.) and “runs in families”; family history may or may not be indicator – because it

is often incomplete.


Explain: Provided materials on genomics, genetic testing, personalized medicine

Additional topics: More information on consent forms and their ethicacy.

Bonnie Hirschhorn Session Info: 5/31/2009 Research Review Session for Patient Advocates (Mentors) 0



Comment: Presenters: Dr. Johnson, Sandler, Garber

Significant findings reported: Dr. Johnson reported back on Lung Cancer findings: maintenance therapy given

after standard of care to stop cancer from returning – questions: to live longer or live better? Quality of life is still

the question. Tarceva was discussed as a epidermal growth factor blocker (works with lung and skin cancers).

Question: if given longer will the effectiveness be better? The comparison was made to the cessation of hormone

replacement therapy in the Women’s Health Initiative when there was an increase in heart disease and breast

cancer. Targeted therapies could yield new endpoints (prolonged delay in disease progression vs. longer life). Dr.

Sandler spoke to the issues related to prostrate cancers, the most common non-skin cancer in US men. Treatment

for advanced disease is hormone therapy which blocks testosterone needed for cell growth. The PSA count as

such is not as important as the rate of increase of PSA (if the numbers go up quickly, it is more serious than a

steady higher number). Dr. Garber spoke about PARP inhibitors/platinum as treatment for TNBC and whether it

could make chemo more effective for these patients. Carboplatin and taxanes + PARP yielded a much greater

response (i.e. patients lived longer but there are questions about safety/toxicity). Platinum is used in Poland as a

single agent chemo. It was successful in shrinking tumors and subsequent surgery resulted in less breast tissue

loss. PARP and platinum work in similar ways.

Messages I will take to my constituency: All the new trial results make it a very exciting time for science, doctors

and patients. The scientists are encouraged by clinical trial results but wary of being too optimistic.




on this topic)

Explain:

Additional topics: Discussion/readings on disease progression v. quality of life and communication between

physicians and patients/families in “how to decide” what is in the best interest of the patient.

Bonnie Hirschhorn Session Info: 5/31/2009 Clinical Trials for Frail &/or Older Adults: Definition. Design,

Recruitment and Outcomes 0 Education Hours credit: 1.25

Presenter1: Excellent Presenter 2: Good Presenter 3: Excellent Presenter 4:

Comment: Presenter 1: Jurria, Presenter 2: Extermann; Presenter 3: Muss

Significant findings reported: : I was eager to attend this session as I am intent on becoming “older adult”. Frailty

was defined as being associated with ADL (activities of daily living), weight loss, weakness, poor energy, slowness,

low physical activity, etc. 47% of adults in this above age 70 were determined to be frail. Quality of fragility is a

determinant of who gets to be considered for treatment for cancers. Physical and cognitive state was considered;

physical fragility was the greatest predictor for mortality. Fit older adults were considered as better candidates

for cancer treatment and the connection to who would become less fit as a result of treatment was another

consideration. Geriatric interventions were considered to be a multidisciplinary responsibility and issues of

getting to, understanding, and continuation of care were also discussed. It is interesting to note that staff and

attitudes at the Oncologists offices were also discussed as in “staff does not always like to deal with slow, old

people” so they would be recruited specifically to “deal” with these patients. The issue of recruitment of patients

to participate in treatment as well as trials was discussed. The relationship between patient and family was also

mentioned. The question of quality of life as an outcome of treatment was glossed over!

Messages I will take to my constituency: You may become old. Advocate for the treatment of older adults so that

you too can look forward to care when your day comes.


on this topic)

Explain:

Additional topics: Quality of life as a major determinant in the decision making process for older adults (as well as

many cancer patients) and not the number of days extended onto a life without quality.

Bonnie Hirschhorn Session Info: 5/31/2009 New Targeted Therapies: Predictors of Response & Resistance 191


Presenter1: Barely understood Presenter 2: Barely understood Presenter 3: Barely understood

Presenter 4:

Comment: Presenters: 1 Engelman; 2 Bruggarolas; 3 Jain

Significant findings reported: The takeaway from this session was difficult for this advocate to understand. The

speakers presented on EGFR and Lung Cancer. Genotyping would be necessary for every lung cancer for there to



be an effective outcome. There was also discussion about revising the endpoint for studies related to Lung Cancer

– i.e. no longer speak about disease free survival but about delayed disease progression as the new target. Dr.

Jain spoke about the concept of reduced edema in tumors vs. tumor reduction or tumor “disappearance” as a

marker to indicate a positive endpoint in Lung cancer treatment.

Messages I will take to my constituency: The message to take home is that cancer treatment “success” can be

measured differently by several indicators. Be certain that you know what is being “measured” and understand all

implications as you make treatment decisions.


on this topic)

Explain:

Additional topics: . More information on “measurements” of outcomes from the perspective of patient

satisfaction with communication with the medical professionals.

Bonnie Hirschhorn Session Info: 5/31/2009 Discussion - Lee Ellis, MD 0 Plenary Hours credit: 0.25


Comment:

Significant findings reported: Dr. Ellis discussed the early benefits from mFOLFOX6 and that the 3 year DFS were

not met. Success of bevacizumab and mFOLFOX6 depended on their combination and duration. This combination

did not increase CR. There was response in the first 4 months of the trial, after which the CR was no different

from mFOLFOX6 alone.

Messages I will take to my constituency: Two oncologists, both with great credentials, have diverse opinions with

the same information. What do others say? Be careful what you believe, and believe what you learn based upon

extensive research. Your life in your responsibility.


on this topic)

Explain:

Additional topics: How to “hear” beyond the credentials

Bonnie Hirschhorn Session Info: 5/31/2009 A Phase III trial comparing mFOLFOX6 to mFOLFOX6 +

bevacizumab in stage II or III carcinoma of the colon 0 Plenary Hours credit: 0.25


Comment:

Significant findings reported: : While the results of Dr. Wolmark’s study yielded negative results, the session was

very lively. Early stage colon cancer was treated with Avastin which did not work. Bevacizumab used with

mFOLFOX 6 did not result in significant DFS outcomes in Stage II and III. It was suggested that bevacizumab would

be effective as long as it was given to the patient. However there was concern about toxicity with bevacizumab

given for long term treatment.



Messages I will take to my constituency: A doctor’s enthusiasm may not be based on authentic clinical trial

results. Be careful what you accept; do your homework. Read, read, read and then talk, talk, talk. Get second and

third opinions. And, if they differ, get still another.


Explain: materials on genomics and proteomics were helpful

Additional topics: Communicating with physicians and their staff; getting information over affirmation.

Bonnie Hirschhorn Session Info: 5/31/2009 Random Phase II Trials in TNBC Metastatic breast cancer 0 Plenary

– O’Shaussney Hours credit: 0.25


Comment:

Significant findings reported: PARP1 is up-regulated in TNBC compared to controls. The PFS increases from 3.3

months to 6.9 months with combination drugs gemictanbin/carboplatin in TNBC metastatic breast cancer. There

was improved C.O., ORR, PFS and O.S with the combination drugs. There were no issues with safety or toxicity of

a significance detected in this study. A Phase III study is planned based on the statistically significant results of

this study.

Messages I will take to my constituency: The bad news is that you have TNBC with Metastasis. The good news is

that you have TNBC with MBC today. There is hope; there is more hope than there was yesterday. There is even

more hope around the corner.


on this topic)

Explain:

Additional topics: Better understanding of bio-chemistry.

Bonnie Hirschhorn Session Info: 5/31/2009 New End Points for new treatments: A Time for Changing

Treatment Benefits 205 Education Hours credit: 1.25


Comment: Presenters: 1: Booth, 2: Averbuch; 3: LoRusso

Significant findings reported: The evolution of RCTs has been the improvement of RCTs. The number of RCTs has

increased over the past 3 decades. The rate of breast cancer has been stable, NSCLC h as increased as had

colorectal cancer. Most RCTs at this time are international in scope. Most trials are now supported by industry

(previously it was government funding). Positive trials, objectives (QOL, CB,NFA, TTP, PFS, ORR, RR) are all

measured in RCTs. Positive trials are more likely to be published and trials that have OS as an endpoint are likely

to be funded by the government as industry does not “wait” for many years for outcomes for trials. Bias from the

point of view of the PI is also a factor in how results are reported in RCTs. The best design is for Phase 3 trials.

There has already been screening out of “what did not work” in the Phase 1 and 2 trials; trials must be large

enough to show strength in outcomes; patient accrual is difficult and predicting survival outcomes must utilize all



information and have consistency for endpoints for their to be measurable and comparable results. Resources

are limited to patients’ finances and time. Who pays for participation in a CT is a very critical question for PIs at

this time.

Messages I will take to my constituency: Endpoints for trials are “moved” to support results. What is important

to the patient? What is important to the investigator? What is important to the funder? Are there strong

correlates? Who’s agenda will determine what RCTs are implemented and who participates?


on this topic)

Explain:

Additional topics: Once again, communication between the parties; clarity of purpose and feasibility for the PI,

patient and funder.

Bonnie Hirschhorn Session Info: 6/1/2009 Endocrine Therapy for BC: Where we are. Where we are headed 520


Presenter1: Very good Presenter 2: Excellent Presenter 3: Excellent Presenter 4:

Comment: Presenter 1: Davidson; 2: Burstein; 3: Dixon

Significant findings reported: Treatments for pre and post menopausal MBC patients need to be considered

differently. Ovulation is an issue with premenopausal younger women and AIs could be the “way to go” in their

treatment . AIs may the first line drug; not all AIs are the same. Tamoxifen is the standard of care for ER/PR + BC

patients and may be an alternative to chemotherapy. The concern expressed dealt with ovarian suppression. The

OS and HR are little different for Tamoxifen and AI – so the issue would be the side effects of the drug and

previous history of morbidity. It was also suggested that endocrine therapy be considered neo-adjuntativley for

patients as there is evidence to show tumor reduction with AI for IBD and Invasive lobular breast cancer. Tumor

size reduction was observed over time and thus there was breast conserving surgery was a better alternative to

mastectomy.

Messages I will take to my constituency: Ask questions; do NOT automatically do your Mother’s (friends, aunts,

etc) treatment. This is a patient targeted therapy and everyone and their cancer are different.


on this topic)

Explain:


Bonnie Hirschhorn Hours credit: 15.35



Faye Hollowell Session Info: 5/29/2009 Fundamentals of Clinical Trial Design 118 Education Hours credit:

2.25

Presenter1: Very good Presenter 2: Good Presenter 3: Very good Presenter 4: Excellent

Comment:

Significant findings reported: Excellent information on the characteristics of each phase of a clinical trial. The

ongoing need to improve the efficiency of subsequent trials; objectives of each phase of a clinical trial was

discussed; statistical issues in clinical trial designs are the effect of chance and the effect of bias which is

controlled by having an adequate number of patients in the study (not the only control); there are different

control groups such as no treatment or placebo, standard treatment or multiple treatment;

Messages I will take to my constituency: That clinical trials are valuable for improving health or at least will

enhance basic scientific/research knowledge.


on this topic)

Explain:

Additional topics: I wish there were more statistics on why certain ethnic groups have been disproportionately

enrolled in clinical trials. I still believe the low enrollment is tied directly to exclusion or unrealistic eligibility

requirements.

Faye Hollowell Session Info: 5/30/2009 Crossing the 3% Barrier: Improving Accrual and Access to Clinical

Trials 224 Education Hours credit: 1.25


Comment:

Significant findings reported: Patient concerns still include: communication and consent, fear of being given a

placebo, costs/insurance coverage, FDA trust I did not feel this session afforded any new information.

Messages I will take to my constituency: None


on this topic)

Explain:

Additional topics:

Faye Hollowell Session Info: 5/30/2009 Bringing God to the Bedside: Addressing the Diverse Spiritual &

Religious Experience of Pts. with Cancer 202 Education Hours credit: 1.25

Presenter1: Very good Presenter 2: Excellent Presenter 3: Good Presenter 4: Very good

Comment:



Significant findings reported: Realistic issues that doctors and nurses see in their patients and face themselves;

patients want doctors to focus on providing medical care, but most welcome discussion about their spiritual

concerns when they face a life-threatening illness; unmet spiritual needs my lead to dissatisfaction with care and

to perceptions of lower quality of care; doctors tend to be less religious than their patients; doctors seldom

inquire about their patients' spiritual concerns citing they lack the time or expertise to engage in dialogue about

spiritual concerns; understanding what matters to each pr. and what brings comfort should concern doctors and

if religion and spirituality are deemed as coping mechanisms, then a failure to address those issues could be

considered a type of neglect;

Messages I will take to my constituency: Ask, listen and pay attention Know the religious factors that are

important to you and share those with your care providers being careful not to pass judgment if you have to

initiate the subject Be sensitive, nonjudgmental in your discussion of religion


on this topic)

Explain:

Additional topics:

Faye Hollowell Session Info: 5/30/2009 Clinical Trial Barriers & Ideas Special Session in Advocates Lounge (Fran -

facilitator) Hours credit: 1.50


Comment: Group discussion on clinical trial barriers and ideas.

Significant findings reported: Clinical trial needing 8 thousand women with a 50/50 split between the US and

overseas participants. Participants easily accrued in other countries since participation is not an option before

certain treatments. Care providers should be mindful of dialogue vs. monologue when it comes to discussing

patient care.

Messages I will take to my constituency: Ask lots of questions. Engage in "dialogue" with the doctor/nurses. Ask

about all treatment options available. Stress the following: -patient aggressiveness regarding treatment

questions -patient education -patient demand for inclusion in applicable trials -patient fears should be discussed

at length -patient educational level should always be considered


on this topic)

Explain:

Additional topics:

Faye Hollowell Session Info: 5/31/2009 Physical, Psychological and Cognitive Challenges of Long-Term

Cancer Survivors 329 Education Hours credit: 1.25


Comment:



Significant findings reported: Goals for survivors are: - optimize physical and psychological health and QOL

following diagnosis and treatment - practice healthy lifestyle behaviors (exercise, normal body weight, good

support network) - adhere to preventive health behaviors such as screening and/or treatment for cancer and

other chronic conditions Doctors are addressing/researching whether survivors are at increased risk for mental

disorders; they look at the risk for suicides; they track depression, anxiety and posttraumatic stress disorders for

any related impairments

Messages I will take to my constituency: Talk to your doctor about any impairments whether physical or

emotional.


on this topic)

Explain:

Additional topics:

Faye Hollowell Session Info: 5/31/2009 New Results from Prostate Cancer Prevention Trials 321


Presenter1: Good Presenter 2: Good Presenter 3: Barely understood Presenter 4: Barely

understood

Comment:

Significant findings reported: I attended this session to hopefully learn preventative measures to take back to my

community. A relative (50 yrs old) recently underwent prostate cancer surgery and to my knowledge was not

approached about preventative measures during annual physicals that preceded his diagnosis. The discussion

focused on 5-alpha Reductase Inhibitors and I was unable to really take anything away.

Messages I will take to my constituency: Continue to be screened.


on this topic)

Explain:

Additional topics:

Faye Hollowell Session Info: 5/31/2009 Clinical Trials for Frail and Older Adults: Definition, Design,

Recruitment & Outcomes 304 Education Hours credit: 1.25

Presenter1: Good Presenter 2: Barely understood Presenter 3: Good Presenter 4:

Comment:

Significant findings reported: - Excellent overview of pt concerns that should be addressed up front such as the

need for hospitalization or not, functional or cognitive impairment, quality of life/survival - a very basic and

useful description of those daily living activities important to geriatric pts. such as basic healthcare skills,

independent living skills in the community - a list of factors defining frailty - a chart depicting the pathway to

frailty



Messages I will take to my constituency: Many of my constituents are elderly, but not frail. They need to know

that trial designs consider them as well.


on this topic)

Explain:

Additional topics:

Faye Hollowell Hours credit: 10.00



Sean Huiras Session Info: 5/29/2009 Myelodysplastic Syndromes: When and How to Treat 103


Presenter1: Barely understood Presenter 2: Good Presenter 3: Good Presenter 4:

Comment: use of multiple graphs on slide without sufficient labeling, difficult to interpret in allotted time.

Significant findings reported: Changing methods of classifying disease from low to high risk based on Bone

Marrow Blasts. Iron toxicity with transfusions in patients correlates with decreased survival. Less transfusion is

better in MDS. Greatest risk of death 50% d/t infection; cardiogenic/bleeding 20-30% Mainstay of tx for low risk

(<10% marrow blasts) is Fe chelation, EPO + G-CSF, Immunomodulation, Lenalidomide in certain subsets (early

anemia and non myelosuppresed). In High risk (>10% Marrow Blasts) Chemotherapy and azacitidine better

outcomes. Newer treatments for Graft versus host disease finding success with steroid resistant disease:

antithymocyte globulin (ATG) and possible lymphocyte infusion.

Messages I will take to my constituency: Bone marrow failure exists on many levels. Inherited vs acquired.

Some treatments are similar with regard to transfusion/transplant. Ongoing research into best method for

sustained outcome and less complications. On what level should pretreatment conditioning be done in a

myelosuppressed population? Needed ongoing discussion with primary care docs and oncologists with regard to

our disease and differentiating disease: age of onset, genomics/cytogenetics, marrow analysis hyper vs

hypocellular. Common treatments such as transplant. Should hematopoetic GFs be given more trials in our

population for neutropenia and anemia?


Explain: appendix gave nice outline of different cytogenetic tests, FISH and other DNA detection methods.

Additional topics: transfusion peripheral versus marrow/ablative pretreatment and toxicity Graft versus host,

prophylaxis against and treatment erythropoesis

Sean Huiras Session Info: 5/30/2009 Diet, Exercise and Cancer: does the Evidence Support Lifestyle

modification as part of cancer treatment 137 Education Hours credit: 1.25


Comment: didn't seem to be conclusive. Studies presented appeared to be anecdotal rather than show much

evidence. Quite specific to few interventions.

Significant findings reported: Exercise seems to suggest less recurrence possibly related to modulation of

hormones, though no change in risk of recurrence demonstrated. Does lessen fatigue in cancer patients. Energy

restriction reduces cancer mortality in animal model. Ultimately, findings suggest any effects are

multicomponent: energy restriction, behavior modification, exercise. Guidelines: exercise-follow recs for general

population diet-vegetable,fruit, grain. decrease sugar, processed food and red meat intake. Supplements in CA

prevention: beta-carotene, vit E increase risk; vit d, Selenium no benefit; multivit > 7/wk increase fatal prostate

CA risk. Vitamin D: findings inconsistent with respect to change in Breast CA. Possible modest decrease in risk

for colorectal CA. Increase risk in Prostate CA. Overall the effects of Vit D on mortality and CA seems to be

curvilinear. Too much and Too little show increases. Need to further explore Vit D on a molecular level. There is

a weak relation between Vit D and serum level.



Messages I will take to my constituency: Exercise and sensible diet, Mediterranean likely most beneficial, may

not change risk, but will likely benefit quality of life. Multivitamins are likely of no benefit if taking adequate diet.

Vit D supplement, most sensible seems to be Canadian guidelines, especially in northern latitudes: Take a

supplement of Vit D of 1000 IU during the winter months.


on this topic)

Explain:

Additional topics: More nutritional sciences, American cancer society guidelines (will look up).

Sean Huiras Session Info: 5/30/2009 genetic testing and society 124 education Hours credit: 1.25

Presenter1: Very good Presenter 2: Excellent Presenter 3: Very good Presenter 4:

Comment:

Significant findings reported: Utility of Microsatellite instability and mismatch repair genes using

immunohistochemistry for identification and diagnosis of Lynch syndrome in colorectalcancer. Difficulty with

typical system of informating gathering to increase chances of catching disease (compliance, history taking, tissue

gathering. Genetic screening and IHC better now. But is genetic screening always helpful? Debate ongoing over

clinical utility. does it just lead to more tests/labs even though it is not affecting mortality. Over the counter

tests/direct to consumer tests capitalizing on society. Not necessarily standardized, using different

algorithms/SNPs to determine risk. may provided false sense of security. Question disclosure of tests, their

limitations and accuracy. Second yield of tests, more tests? should we act on it? How informative are the

companies and there is an opening role for more patient advocacy with theses tests against the

commercialization.

Messages I will take to my constituency: The knowledge gained at screenings does not always mean utility today.

Be wary of over-the-counter labs/tests. Not always fully informative/accurate. room for error. Lab

discrepancies, etc. Know your history, family history. Donate tissue! Ask questions regarding consent. Know

your rights. What do the results of tests mean. Sometimes the tests we submit to don't always mean results

today, or we don't always know what to do with them. Are your providers referring to other providers and

communicating why and how tests should be used? We need to be our own advocates and pressure our providers

to communicate. Seems to be a bigger issue than the insurance company when it comes to screening.


Explain: Education on basic genetic science, advocacy and consent were all helpful.

Additional topics: More details re: genetic info non-discrimination act Is it followed? Do providers inform

patients? Do insurance companies find loopholes?

Sean Huiras Session Info: 5/31/2009 Plenary Session including Science of Oncology Award and lecture 1

Plenary Hours credit: 2.00




Comment: Good insight into interesting topics, explained well in followup sessions .

Significant findings reported: Cancer genomes decoded: ~63 mutations per tumor cell. ~only 12-15 of these

mutations are drives for causing disease. 12 core pathways involved. Future: vaccine against cancer, get

immune system to recognize. Next generation sequencing for those at risk to predisposition, early diagnosing

(i.e. colorectal cancer with defined series of mutations. Digital genetics: looking at normal vs mutant alleles in

body diff body fluids, less invasive Novel therapies with PARP (polyADP Ribose Polymerase) inhibitors in triple

negative BR CA in concert with chemotherapy preliminary show benefit overall response ans survival progression

with no increase chemo toxicity. In metastatic ovarian cancer, use of CA-125 levels as monitoring tool for

recurrence may be overused or leading to overtreatment. Considering treatment only in symptomatic cases of

recurrence.

Messages I will take to my constituency: Novel therapies looking at PARPS and Tankyrases. Could impact

Dyskeratosis community. Very interesting studies looking at cancer cells and ability to activate telomerase to

immortalize themselves. Novel therapies look at telomerase inhibitors, PARP, Tankyrase and other telomere

directed therapies. Impact of these interventions on our population (dyskeratosis) questionable/concerning

Did the course materials help you understand this session? NoN/A to this session (pre-ASCO materials not


Explain:

Additional topics: Chemotherapy agents/basics. Always come up in lectures and basic understanding of this

would likely be helpful to RAN group

Sean Huiras Session Info: 5/31/2009 Evaluating Cancer Therapies in RCTs and Beyond: What Leads to

Real Benefit in the Real World? 205 Education Hours credit: 0.45


Comment: Great speaker providing good insight into the dynamics of clinical trials, flaws and endpoints for

improvement.

Significant findings reported: Need to improve clinical trials being reported. More funding coming from for

profit groups, industry and are more likely to call their trial positive. Positive trials are getting more publishing

(publication bias). Endpoints need to be focused on survival/significant endpts. (quality of life, clinical benefits),

not simply a response to some therapy. Data and Safety monitoring board: need these to provide internal

analysis of study; should it keep going? Prevent early reporting of trials due to some people making changes in

clinical practice, and there is a bias then with ongoing study. Follow guidelines, decrease failures. Late failures in

development have greatest impact on cost.

Messages I will take to my constituency: We need to be selective about any funding we provide to trials. Need

to collaborate with/create medical board to review potential studies. Be cognizant of biases in studies.


Explain: any insight into clinical trial and design helped

Additional topics:



Sean Huiras Session Info: 5/31/2009 Providing Best Treatment for Head and Neck Cancer Patients in a

Community Based Practice 233 Clinical Problems in Oncology Hours credit: 1.25

Presenter1: Good Presenter 2: Very good Presenter 3: Good Presenter 4:

Comment:

Significant findings reported: Surgery: Overall, surgical treatment for head and neck cancer has changed much.

Getting somewhat better with endoscopic, robotic, organ preserving therapy with better reconstructive

techniques. There may be a role for neoadjuvant therapy for all (radiation, chemoradiation) Radiation: Newer

techniques attempt to minimize toxicity. IMRT (Intense Modulated Radiation Therapy) uses numerous fields with

intensity modulated to provide max dose at center. Leads to less radiation associated morbidity. Chemotherapy

remains still toxic. Combination of RT and Chemo better than RT alone.. Dose de-escalation dose not improve

survival, only tumor control. In the future attempt to personalize dose Ultimately need multidisciplinary referrals

Messages I will take to my constituency: We are at high risk for head and neck tumor. Ensure multidisciplinary

approach. Role for Chemo in at risk population for cancer treatment. Personalized medicine important. We are

even more susceptible to radiation induced head and neck tumors. Risk/benefit. Possibly great role for surgery

in our population due to toxic effects of adjuvant therapies. Smoking cessation paramount! Minimize alcohol.

Role for HPV immunization in women AND men (when available) in our population to prophylaxis against

head/neck HPV induced tumors.



Explain:

Additional topics:

Sean Huiras Session Info: 5/31/2009 Management of unusual plasma cell dycrasias (excluding

myeloma) 234 Clinical Problems in Oncology Hours credit: 1.00


Presenter 4:

Comment: This was mostly composed of case reviews and "what would you do" scenarios. Very technical overall

Significant findings reported: Monoclonal Gamopathy of unknown significance: >IgG elevation. No role for

cytogenetics in diagnosis. Get CT eval lymphadenopathy/hepatosplenomegaly. Waldenstrom's

Macroglobulinemia: >IgM monoclonal elevation. Ultimately treatment guided by disease severity and transplant

eligibility. REFER to clinical trial. Amyloidosis: get UA. Poor prognosis with cardiac involvement. cytogenetics not

prognostic. Stem cell transplant with G-CSF (granulocyte-colony stimulating factor). watch for splenic rupture

with stem cell mobilization. Solitary Bone Plasmacytoma and solitary extramedullary plasmacytoma: suspect

with bone lesion. Bone marrow bx not c/w myeloma, no change in serum monoclonal proteins. Overall survival

and disease free survival better with medullary vs extramedullary. >94% local control with radiation alone with

bone lesion. POEMS syndrome: overlap with other diseases, usually misdiagnosed first with other neuropathic

conditions. don't be fooled by radiology report. Treatment algorhythm- radiation, alkylators, steroids,

transplant, and novel treatment: immune modulator. Ultimately, be patient with therapy, may take month or

longer



Messages I will take to my constituency: Did not get a great value from this session for my constituency.


on this topic)

Explain:

Additional topics:

Sean Huiras Session Info: 5/31/2009 Management of unusual plasma cell dycrasias (excluding

myeloma) 234 Clinical Problems in Oncology Hours credit: 1.00


Presenter 4:

Comment: This was mostly composed of case reviews and "what would you do" scenarios. Very technical overall

Significant findings reported: Solitary Bone Plasmacytoma and solitary extramedullary plasmacytoma: suspect

with bone lesion. Bone marrow bx not c/w myeloma, no change in serum monoclonal proteins. Overall survival

and disease free survival better with medullary vs extramedullary. >94% local control with radiation alone with

bone lesion. POEMS syndrome: overlap with other diseases, usually misdiagnosed first with other neuropathic

conditions. don't be fooled by radiology report. Tx: radiation, alkylators, steroids, transplant, and novel

treatment: immune modulator. Ultimately, be patient with therapy, may take month or longer

Messages I will take to my constituency: Did not get a great value from this session for my constituency.


on this topic)

Explain:

Additional topics:

Sean Huiras Session Info: 6/1/2009 Acute Lymphocytic Leukemia: What's next 0 1.25 Hours credit: 1.25

Presenter1: Good Presenter 2: Good Presenter 3: Barely understood Presenter 4:

Comment:

Significant findings reported: Age related outcomes in transplant for overall survival in ALL. Reduced intensity

conditioning in: older and younger patients with comorbidities. (overall survival 30%, increased relapse rate, 1/3

treatment related mortality, outcome ralted to stage of disease) Better results for autologous trplt. Imatinib

after stem cell transplant (before and after for better results), give 1 year while maintain negative status. For

standard risk patients: chemo + stem cell transplant High risk: autologous trplt 60% success In philidelphia

chromosome ALL: Chemo and Imatinib better than Imatinib alone. Stratify those for stem cell transplant

Tyrosene kinase inhibitors improve results. In early adult ALL (currently treatment model is for pediatric vs older

patients): -there should be hyrid treatment that recognizes age as a negative prognostic factor, delay and modify

regimen with consolidation and maintenance. age 0-20 use pediatric protocol; 20-35 pediatric inspired; 35+ adult

protocol



Messages I will take to my constituency: ALL in dyskeratosis population, again need to make provider aware of

disease and need to involve specialists, considerations for anaplastic nature of disease, role for chemo, modifying

regimen.


on this topic)

Explain:

Additional topics: stem cell transplants, chemotherapy

Sean Huiras Session Info: 6/1/2009 comprehensive Risk Assessment for Hereditary Cancer Syndromes 0

Clinical Problems in Oncology Hours credit: 0.50

Presenter1: Presenter 2: Excellent Presenter 3: Presenter 4:

Comment:

Significant findings reported: Young, non smoker/nondrinker with head/neck tumor suspect rare conditions,

fanconi's anemis/dyskeratosis. Unusual reaction to ionizing radiation, chemotherapy toxic. Need to personalize

dosings in these patients when treating cancers. Cumulative risk for head/neck tumor is equal in dyskeratosis

congenita and fanconi's anemia.

Messages I will take to my constituency: We are high risk patients, careful lifestyle decisions Make sure

providers know your risk. Provider's approach to conditions should be multidisciplinary, involve specialists from

multiple fields to deal with problems (hematology/oncology, ENT, genetic counselors. Tailor treatments. Get

involved with clinical trials.


on this topic)

Explain:

Additional topics: chemotherapy, administration, effects on marrow cell production

Sean Huiras Session Info: 6/1/2009 Personalizing Treatment for Squamous Cell Cander of the Head and

Neck 0 Clinical symposium Hours credit: 0.45

Presenter1: Presenter 2: Excellent Presenter 3: Presenter 4:

Comment:

Significant findings reported: Genomics or High risk patients susceptible to head/neck tumors? Epidemic

tonsilar/bse tongue CA HPV+ type 16 die from disseminated dz. Never smoked do better. Current smokers who

are HPV - 5x more likely to have recurrence of tumor than never smoked. Current smokers who are HPV + 7x

more likely to have recurrence of tumor than never smoked. No demonstrated negative synergistic effect of

smoking+HPV status. ~85% respond to induction chemo with subsequent chemoradiation HPV + tumors have

more favorable survivals than HPV neg tumors. The question is whether we need to stratify HPV +/- tumors

before treatment (take into account lifestyle factors: tob, etoh, sexual behavior.



Messages I will take to my constituency: Again raises the question, should all dyskeratosis patients be screened

for type 16 HPV and vaccinated men/women as available. Again, preach lifestyle factors.


on this topic)

Explain:

Additional topics:

Sean Huiras Session Info: 6/1/2009 ASCO/American society of Hematology Symposium: Best of ASH 284

Special Session Hours credit: 1.25

Presenter1: Good Presenter 2: Good Presenter 3: Good Presenter 4: Barely understood

Comment:

Significant findings reported: 1. Nadroparin helped decreased chance of thromboembolic event by up 50% >

effect in ambulatory lung CA patients, no benefit in pancreatic or other CA types. 2. Meta-analysis of

Recombinant Human Erythropoesis stimulating agens in CA patients. Overall no benefit and study suggested

increase in mortality and worsened overall survival. ? if increase thromboembolic events and stimulated tumor

growth. Study was limited and needs ongoing analysis. 3. Retrospective 148 center study using allogenic SCT in

older patients with AML, MDS >65. No age related difference in survival with ruduced intensity non-myeloablative

trplt. 4. Ideopathic thrombocytopenic purpura: Dexamethasone vs Rituximab and dexamethasone. Doubling of

response if given with Rituximab. No safety differences, no increase adverse events. Same relapse rate/disease

free survival. Use for refractory patients to dexamethasone alone.

Messages I will take to my constituency: Not really applicable to our population. quite specific. Interesting,

applies to some meds we may take.


on this topic)

Explain:

Additional topics:

Sean Huiras Session Info: 12:00:00 AM Fundamentals of Clinical Trial Design and Methodology 267

Extended education session Hours credit: 2.00

Presenter1: Very good Presenter 2: Excellent Presenter 3: Good Presenter 4: Very good

Comment: Great overall. Some of the mathematical statistics is a bit too much, but overall great presentation,

fundamental to looking at studies.

Significant findings reported: Breakdown of different phase studies, intended outcome of each from 0-4.

Randomized controlled are the standard, help to control for bias, unknowns, standard/eligible selection and tries

to account for time trends. Single arm studies tend to be biased. Observational studies are epidemiological,

phase I/II studies, generate hypothesis and gather data. In all, greater need to collaborate between labs,

clinicians, biostatisticians to keep costs down, standardize tests/imaging/tissue handling, etc. Wary of Simpson



Paradox, applying same standard to one set may make results appear better. Must ensure we meet criteria and

improve trial design to comply with the following: Is there a social value, scientific validity, fair subject selection,

Risk/benefit analysis, independent review and informed consent. Informed consent to patient: study is

voluntary, capacity of them to understand and the capacity of the study to treat (may be minimal) i.e. the

therapeutic misconception. Full disclosure, understanding of their disease and the study/trial, right to decide.

Apply common rule: nature/purpose of study, procedures involved, duration, risks, experiments, current

treatments, study contacts for information/questions, right to withdraw, confidentiality, gratitude.

Messages I will take to my constituency: Clinical trials come on various levels in their purpose, but also in their

capacity to benefit society or science in general, possibly negatively if their design is not improved. Involvement

is for benefit of society > themselves. Ask a lot of questions. Look at the intentions of the study; does it meet

criteria outlined above both in design and in disclosure to us as participants? Be informed participants! Who is

conducting the study and for what purpose? Do you feel comfortable being involved? Do you feel questions are

answered? Remember right to withdraw. There is much work to do to make clinical trials more efficient from

cost and conduction perspectives.


Explain: Great introduction to prepare for terminology and basics.

Additional topics: Perhaps one of the webinars could compare two studies/papers. One well designed with

objectives met and one poor design with flaws for examples. Still a little unclear of studies "power"

Sean Huiras Session Info: 12:00:00 AM Genetic Risk Assessment within the Community Oncology

Practice: Opportunities, pitfalls and resources for program development 136 Education Hours

credit: 1.25


Comment:

Significant findings reported: Genetic risk assessment involves: Providers knowing natural history of disease, risk

assessment is cross disciplinary (gathered from multiple sources/providers) and genetic testing role should be

offered to those at risk, with pre/post test counseling and informing them of lifetime risks and the limitations of

testing that leaves them open to basic risk even if negative. Family history should be 4 generation pedigree,

identifying proband. developing a risk reduction strategy. Follow ELSI guidelines to patient AND family. know

state laws with regard to informing family, level of responsibility. Refer early when needed. Pitfalls: family

history, patient compliance, ? limitations of traditional genetic counselors (compliance/billing/training), failure to

dx in young patients with family history, liability if not adequately treating known disease. Establish "experts" in

oncology for area. ongoing training programs for oncologists as genetic counselors is increasing testing and

detection of disease.

Messages I will take to my constituency: Again, know family history. ensure PCP is referring when needed. Need

to work on public relations, provider education with inherited bone marrow failure syndromes. early

establishment with oncologist. Are they an expert? Do they even know what it is? Do they know where to send

genetic test? Is the NIH being brought in for direction/are trials being introduced to patient? Do they know the

ICD-9 codes to cover for insurance reasons the litany of screening tests for IBMFSs? V84.xx for "screening for high

risk disease", V82.71 for genetic testing.




Explain: This was fairly focused to the community oncology practice, though all the background and webinars

surely provided the right mindset with descriptions of how testing is carried out.

Additional topics:

Sean Hurias Session Info: 6/1/2009 Board D11 0 General Poster Session Hours credit: 0.50

Presenter1: N/A Presenter 2: Presenter 3: Presenter 4:

Comment:

Significant findings reported: HPV oropharyngeal cancer up, tobacco assoc OPC down, thinking changes sex

behaviors of 70's/80's. disease of younger, white, high income. 24% head/neck SCC are HPV 43% oropharyngeal

cancer are HPV HPV 16 accounts for ~90% of HPV + tumors Better response to chemotherapy than smoking

assoc tumors (HPV-). Better overall survival. treatments to consider antiretrovirals

Messages I will take to my constituency: same as previous. discussed with Merck, makers of Gardasil, they have

studies (4) testing vaccine in men. would discuss testing all d.c. patients for HPV positivity (>100 types, esp type

16) and give vaccine regardless of age, sex, marital status, etc.


on this topic)

Explain:

Additional topics:

Sean Hurias Hours credit: 16.65



Judy Jones Session Info: 5/30/2009 Crossing the 3% Barrier - Improving Accrual and Access to Clinical

Trials Education Hours credit: 1.00

Presenter1: N/A Presenter 2: Very good Presenter 3: Very good Presenter 4:

Comment: Good session explaining the process and problems in accrual and access to clinical trials

Significant findings reported:

Messages I will take to my constituency: Probably won't take any of this to my constituency, but have a greater

understanding of this process and will be able to use this in interactions with biotech and pharms.


Explain: N/A

Additional topics:

Judy Jones Session Info: 5/21/2009 New Endpoints for new Treatments - A time for change in

assessing treatment benefits Education Hours credit: 1.25

Presenter1: Excellent Presenter 2: Good Presenter 3: Excellent Presenter 4:

Comment:

Significant findings reported: There is concern about how to structure phase I clinical trials and to consider

risk/benefit to the patient

Messages I will take to my constituency: Researchers are continually working to construct trials that will provide

information to determine the value of the drug that will also benefit the patient.


Explain: N/A

Additional topics: The education sessions you suggested have been easy for the patient advocate to

understand...giving us suggestions has been very helpful.

Judy Jones Session Info: 5/29/2009 Fundamentals of Clinical Trial Design and Methodology 267


Presenter1: Excellent Presenter 2: Good Presenter 3: Barely understood Presenter 4: Excellent

Comment: Presenter 5 - Excellent

Significant findings reported: Good overview of clinical trials - design, rationale, statistical principles, ethics and

practical considerations.

Messages I will take to my constituency: A better understanding on how oncologists look at clinical trials.


Explain: This was pretty basic material



Additional topics: Better knowledge of statistics would have helped with presentation 3. For patient advocates

who are new, it may be helpful to do a training session on how to read a poster. Early on, a physician did this for

me and it was extremely helpful.

Judy Jones Session Info: 5/30/2009 Results of a Phase I study of Oral Belinostat (PXD101) Poster

Hours credit: 0.25


Comment:

Significant findings reported: There was acceptable safety profile and tumor shrinkage in Mantel cell lymphoma

and Hodgkin's disease.

Messages I will take to my constituency: Belonistat is being looked at in cutaneous lymphomas and could

possibly be another option for treatment pending additional clinical trials


on this topic)

Explain: Research on a specific new treatment

Additional topics:

Judy Jones Session Info: 5/30/2009 PROPEL: Results of the Pivotal, Multi-center, Phase 2 Study of

Pralatrexate 8561 Poster Hours credit: 0.25


Comment:

Significant findings reported: Overall response rate was 28%. Median survival was 14.7 months.

Messages I will take to my constituency: PROPEL is expected to get FDA approval this fall and will be the first

treatment approved for PTCL.


on this topic)

Explain: This poster was specifically for PTCL

Additional topics:

Judy Jones Session Info: 5/30/2009 FDA and EMEA Initiatives: Meeting the Challenge of Oncology Drug

Regulation Education Hours credit: 1.25


Comment: There were two speakers, a moderator and two panel participants



Significant findings reported: Great session discussing both the US and European viewpoints.

Messages I will take to my constituency: I obtained a greater understanding of the process of drug regulation

and can help patients understand some of the issues that frustrate them.


Explain: Easy to understand session

Additional topics:

Judy Jones Session Info: 5/30/2009 MicroRNAs: A new Paradigm 194 Education Hours credit: 0.50

Presenter1: Way over my head Presenter 2: Presenter 3: Presenter 4:

Comment: There was a language issue combined with the topic that made this presentation difficult to

understand.

Significant findings reported: I left the session to attend another one that I felt would be more appropriate.

Messages I will take to my constituency:


Explain: Would have had to teach us molecular biology.

Additional topics: VERY BASIC information on microRNAs.

Judy Jones Session Info: 5/31/2009 Discussing the Cost of Care with Patients with Cancer: What can we

tell them? What is the Cost? Education Hours credit: 1.00

Presenter1: Presenter 2: Excellent Presenter 3: Excellent Presenter 4: Excellent

Comment: Good discussion of cost of care from both patient and physician viewpoints. Ethics involved in

prescribing lesser treatments because of costs to patients (or more expensive treatments that will bring in more

money).

Significant findings reported: None

Messages I will take to my constituency: Physicians are concerned about the costs incurred by patients in

considering different treatments.


Explain: N/A

Additional topics:

Judy Jones Session Info: 5/31/2009 Cancer Vaccines: Where do we go from Here? Education Hours

credit: 0.50




Comment:


Messages I will take to my constituency: Information about the role of vaccines and challenges in lymphomas.


Explain: N/A

Additional topics: More information on how vaccines work in lymphomas.

Judy Jones Session Info: 5/31/2009 Cancer Genomes and their Implications for Understanding and

Managing Cancer Plenary Hours credit: 1.00


Comment:


Messages I will take to my constituency: In the future, cancer will be controlled because it will be recognized

earlier


Explain:

Additional topics:

Judy Jones Session Info: 6/1/2009 Systems Biology, Cancer Therapeutics and Personalized Medicine



Comment: One of the sessions that I was unable to comprehend, so left to attend another session.


Messages I will take to my constituency: None


Explain: N/A

Additional topics: Guess my system biology knowledge is definitely lacking!

Judy Jones Session Info: 6/1/2009 Using the Internet to Keep Current: From Podcasts to Virtual

Meetings to RRS Education Hours credit: 1.25


Comment: Great session! I learned how to get some medical information that I was not aware of before.




Messages I will take to my constituency: Info from this session was valuable to me personally as we redesign our

website using web2 technology. Learned how docs get their info to keep them up-to-date.


Explain: N/A

Additional topics: None...very understandable on it's own

Judy Jones Hours credit: 11.00



stephen kandel Session Info: 5/28/345 11:00:00 PM fundamentals of clinical trial design education Hours

credit: 2.10

Presenter1: Excellent Presenter 2: Very good Presenter 3: Barely understood Presenter 4: Very good

Comment: I felt this was a very good session, except for the statistics section which was poorly understood. I left

Dr. Hilsenbeck's presentation for 15 minutes so I deducted the credit from 2.25 to 2.10 On a personal level I was

very glad I attended this session

Significant findings reported: I believe I much better understand the process and phases of clinical trials after this

presentation. I was not aware of the concept of a goal BED..which is to identify a Biologically Effective Dose. Also

in Phase II trials if presumed target is incorrect it is possible that a useful agent may be inappropriately discarded.

I learned that it is especially difficult to validate if no clinical activity. I also understand now that signaling

pathways are complex and poorly understood. the above comments are from Dr. Abbrruzesse rationale for

randomized trials...Stephen L. George I thought this was a very good presentation. I now understand that the

effect of chance needs to be addressed by an adequate number of patients and the effect of bias can be

overcome by using randomization for treatment assignment. George's statement that "randomized trials were

the main contribution to scientific medicine in the 20th century" really struck me. I appreciated George going

over the uses of non-randomized trials but he made a convincing case that randomized Phase III trials are the best

source of information. Statistics has always been one of my weak links and I found Dr. Hilsenbeck's presentation

somewhat torturous. Not her fault just haven't been able to get my arms around the topic. I need to do more

work in this area. I found the next talk Ethics in Cancer Clinical Research very interesting. The 1994 in which a

researcher didn't want to tell a woman she didn't qualify was a good example of problems that can arise..I now

also better understand the following criticisms- inappropriate control group inadequate sample size poor

statistical analysis unfair subject selection inadequate I also found the discussion on valid consent helpful. I

didn't realize that regarding placebos adults can consent to having a therapy withheld. Tannock's presentation I

thought was very good and he systematically went through the Phases..

Messages I will take to my constituency: It is very hard to advise my constituents because many of them in the

triple-negative-breast-cancer area have metastatic disease with very few options open except perhaps for the

PARP inhibitor trials. So many of these women have failed various chemotherapies that they are excluded,

criteria-wise, from certain trials. I think the main message I have given the women is that it is a long process to

bring a drug to market and it is very hard for a lay person to evaluate whether a trial was designed properly. I

think them main thing is to have a good oncologist who can explain to a patient cogently and understandably why

s/he feels a particular trial may make sende


Explain: I feel that the written material and webinars helped me understand the scientific language used in this

session. It is a cumulative effect and hard to measure specifically in this session but I feel the written materials

and webinars were a help.

Additional topics: I wish I was better at statistics. If I am going to be as serious as I would like as an advocate I feel

I must better develop my skill set in this area.

stephen kandel Session Info: 5/29/515 11:30:00 PM focus on research seminar at asco lounge

roundtable-educational Hours credit: 1.25




Comment: I thought this intimate setting was really great because our questions could be answered. I really

enjoyed being so close to the researchers.

Significant findings reported: The most important thing to me was a short preview of the PARP inhibitors which

for me was one of the most important events of the conference...The detail was not too great because Dr. Garber

would be speaking the next evening. Nevertheless it was helpful to get that perspective. Also I felt optimistic that

because of gene amplification new drugs targeting specific genes will help in the fight against cancer.

Messages I will take to my constituency: The BRCA+ community and the Triple-Negative-Breast Cancer

community that I am deeply involved with are already aware of the PARP clinical trials but the results that have

been presented give some hope to many..


Explain: the textbook and webinars have helped lay a foundation for me to better understand what is being said.

Additional topics: I wish I was more knowledgeable in a lot of areas...I guess one of the things I am most

interested in is when does something become validated enough to become "practice changing?'

stephen kandel Session Info: 5/30/2001 9:00:00 PM Plenary Session Including Science and Oncology Award


Presenter1: Excellent Presenter 2: Excellent Presenter 3: Very good Presenter 4: Very good

Comment: This plenary session was the highlight of the conference for me. I am deeply involved with a

community of women with recurrences and new primaries of breast cancer and metastases to various

organs..primarily lung, brain and bone. Many of these women have,

Significant findings reported: Ovarian cancer remains a disaster. The CA-125 test that so many women in my

community rely on for surveillance of ovarian cancer is unreliable for early detection of ovarian cancer and it also

has, unfortunately proven unreliable, according to Dr. Beth Karlan, for ovarian cancer relapse. The doubling of

CA-125 levels has not proven to be an accurate indicator. I first met Dr. Karlan five years ago when she advised

my daughter to have a LAVH/BSO and I have talked to her often during this time period regarding my wife and

youngest daughter...so that is why I feel I was knowledgeable about what she was going to say. The other thing

she spoke about was the fact that chemo in theory should help but doesn't in recurrent ovarian cancer because of

chemo resistant cells. sometimes repeating chemo cause more harm than good. more and better imaging is

needed and a test for early detection is desperately needed as 80% of ovarian cancer in this country is detected

as Stage III/IV cancer. I have another personal link to Dr. Stephen Schuster because a dear friend of mine, age

41, is one of his patients who had follicular lymphoma and is now in complete remission. I feel, based on my

friend's explanations over the past year that I had a good background for this presentation. The Biovax ID vaccine

has shown good activity although Ron Levy of Stanford (who I met at a previous conference) questioned whether

the criteria for admission to the trial made the results skewed compared to other trials where sick folks were

included as compared to the participants in this trial who had to be in remission for six months before admission

to the trial..He said the participants in this trial were the "best of the best" because of the "complete remission"

requirement. So I think he has a valid point and it it remains to be seen if this will be as effective as Dr. Schuster

hopes it will be. But the Disease-Free Survival figures on a randomized basis were impressive. Overall, I was

encouraged and again on a personal basis my young friend is alive and even talking about becoming a dad again.

The most important presentation of the session today was the announced results from a randomized Phase 2



clinical trial of BSI-201, a poly(ADP-ribose) polymerase (PARP) inhibitor, in combination with gemcitabine and

carboplatin (GC) chemotherapy, in patients with metastatic triple-negative breast cancer (TNBC). BSI-201 is a

novel investigational agent that acts by inhibiting PARP1, an enzyme that repairs DNA damage. "In this study,

116 women with metastatic TNBC, defined by tumors lacking expression of estrogen and progesterone receptors

and without overexpression of HER2, were randomly assigned to receive GC in combination with the

investigational agent BSI-201 or GC alone. Patients assigned to receive chemotherapy without BSI-201 were

allowed to receive BSI-201 at the time of disease progression. The primary study endpoint was the rate of

clinical benefit, defined as complete or partial response or stable disease of at least 6 months. Secondary study

endpoints included progression-free survival, overall survival and safety. Approximately 62 percent of patients

receiving BSI-201 in combination with GC showed clinical benefit, compared with 21 percent in the group

receiving chemotherapy alone (p= 0.0002). Tumor response (complete or partial response) was observed in 48

percent of patients who received BSI-201 combined with chemotherapy, whereas patients receiving

chemotherapy alone showed a response rate of 16 percent. Women who received BSI-201 had a median

progression-free survival of 6.9 months and overall survival of 9.2 months compared with 3.3 and 5.7 months,

respectively, for women who received chemotherapy alone." The TNBC community is of particular interest to

me because 85% of BRCA1+ women who have breast cancer have tumors that are TN. That is the type my

daughter had. I have been waiting for these figures for quite some time and also look forward to the figures to

be announced at some point regarding the PARP trials and ovarian cancer. Being in attendance at this plenary

session I felt I was part of history. Elda, thank you for facilitating that for me..

Messages I will take to my constituency: I posted information on the FORCE website and the Triple-Negative site

but in addition to stressing the positive nature of the finding cautioned that the drug would not be available

anytime soon and it certainly is not a cue. Nevertheless it is a very hopeful development I feel.


Explain: the book explaining the genome was particularly useful

Additional topics: I need more exposure to basic biology.

stephen kandel Session Info: 5/31/2003 9:15:00 PM new biologic and therapeutic insights from hereditary

cancers education session Hours credit: 1.25


Comment: I am a huge Dr. Andrew Tutt fan. I first met him when he presented on PARP at a FORCE conference

three years ago. He was very approachable at the conference and I was very pleased when he remembered me

when I spoke to him after his presentation...He is es

Significant findings reported: PARP binds directly to DNA single strand DNA damage. BRCA is a genomic

catastrophe that causes cell death. He is trying to answer the question "can we target BRCA1/BRCA2 tumor's DNA

repair weakness? He mentioned two new trials NCT 00540358 and NCT 00707707 and also mentioned that the

jury is out on the effectiveness of cisplatin with ovarian cancer.

Messages I will take to my constituency: I have reported and will continue to report the new PARP trials..Dr. Tutt

feels PARP inhibitors are an exciting new class of agents..


Explain: as I wrote before..The Genomics in Cancer book was a perfect primer for this session. Thank you!



Additional topics: same comment..I need a deeper background in biology..

stephen kandel Session Info: 5/30/2008 2:15:00 AM Genetic Testing and Society 0 education Hours credit:

1.25

Presenter1: Excellent Presenter 2: Excellent Presenter 3: Good Presenter 4:

Comment: Lynch Syndrome and the Clinical Genetics Dept.'s work at MSKCC are two topics that I am very

interested in. One of my closest friends has Lynch, a dx he received after I got involved for him as an advocate. His

doctors in Las Vegas never tested him even t

Significant findings reported: the significant findings from the Lynch Syndrome presentation by Heather Hampel

may not be new, necessarily but they were new to me so I am reporting them here: -Lynch Syndrome is the most

common inherited cancer -risk for endometrial cancer in women is higher than risk for colon cancer.. -family hx

can be deceiving because of wider use of colonoscopy which is likely to prevent colon cancer I thought the two

most significant facts reported by Ken Offit were- -Memorial Sloan Kettering Cancer Center has started a new

policy of testing ALL ovarian cancer patients for the BRCA mutation despite family hx. The program will be under

the direction of Dr. Noah Kauff who is my daughter's gynecologist and they have hired a new full-time CGC from

Australia to work on the program. This is a very significant program.. also he warned of direct-to-consumer

genetic testing programs that have virtually no government oversight, give wrong info, and make inaccurate

claims. I thought Angela Bradbury's presentation on informed consent was interesting and re-inforced the

difficulties of using the 'traditional model' for informed consent because of the variety of tests available...often

without a proper explanation from a Certified Genetic Counselor. one of the significant findings for me came

from a question in the audience from a member of our Armed Forces. Incredibly, the recent GINA bill, which does

much to forbid discrimination regarding genetic conditions, specifically exempts members of the Armed Forces

from the provisions of the bill. Dr. Offit, one of the authors of the bill seemed astounded. The Armed Forces in its

infinite wisdom feels that a genetic condition is a pre-existing condition therefore is excluded from care. What an

unbelievably disgusting policy. People seriously disadvantaged...so unfair to the marvelous mena nd women

serving our country.

Messages I will take to my constituency: I will stress how important surveillance is for those with Lynch

Syndrome.. I have posted extensively on ovarian cancer on the FORCE board and posted Dr. Offit's new program.

I have also warned folks about the risks of getting tests that may not be properly explained. I also posted about

Armed Forces situation since FORCE has been instrumental in getting GINA passed.


Explain: background info on Human Subjects webinar was VERY helpful

Additional topics: I would like to understand how PGD works specifically, technically... also, I would like to know

how the author of a bill doesn't know how an important clause gets into the final language without him being

consulted.

stephen kandel Session Info: 8/10/2009 8:47:00 PM cisplatin chemotherapy in the treatment 0f BRCA1+

metastatic breast cancer poster Hours credit: 0.75




Comment: I found most of the poster presentations difficult to follow..many handout sheets were not available

and next time I really need to get the programs in advance so that I can key in on particular sessions...I had lunch

with Kendall Bergmann and was not abl

Significant findings reported: Cisplatin should be considered as an agent for metastatic breast disease in BRCA1+

but additional work needs to be done. "Significant activity and favorable toxicity profile provides a basis for

considering Cisplatin for further evaluation in Phase III trials with BRCA1+ MBC. This is research done in Poland

and Dr. Steve Narod who goes to Poland every year has

Messages I will take to my constituency: to speak to their oncologists about using cisplatin..there are other

studies I have found on PubMed since ASCO that seem to indicate cisplatin can be helpful..


Explain: in a general way..

Additional topics: my overall impression of the poster sessions is that all too many were over my head...I have

much work to do.

stephen kandel Session Info: 5/29/2012 6:00:00 PM breast cancer poster Hours credit: 1.00

Presenter1: Very good Presenter 2: Very good Presenter 3: Good Presenter 4: Very good

Comment: I am particularly interested in breast cancer and within that category particularly interested in triple

negative breast cancer

Significant findings reported: I would not categorize anything that I saw as super significant..still a long way to go

Messages I will take to my constituency: I am thankful that there is so much work being done on breast cancer,

in general..but nothing really bounced out as super-significant.


Explain: as a general rule the written materials provided and webinars have helped me in ways I cannot quantify

precisely but they have been very helpful

Additional topics: just would like to have a deeper scientific background so that I can better understand.

stephen kandel Session Info: 12:00:00 AM Basal-like and triple negative breast cancer definition and

therapeutic insights clinical science symposium Hours credit: 1.50

Presenter1: Very good Presenter 2: Good Presenter 3: Good Presenter 4: Good

Comment: I have an intense interest in Triple-Negative-Breast-Cancer. My daughter is BRCA1+ and Lisa Carey

mentioned that 80% BRCA1+ women who have breast cancer have TNBC like my daughter did. I have been

actively posting on the TNBCF site. It is different than

Significant findings reported: Lisa Carey's presentation was similar to a presentation I saw on a Living Beyond

Breast Cancer teleconference so for me no major new news. Dr. Tutt, one of the researchers presented

evidence of the olaparib drug. it seems to show good activity. and the 400 mg dose is much more effective than



the 100 mg dose. The drug was "well tolerated". There is "ongoing discussion to accelerate approval" according to

Dr. Tutt who was questioned by a oncologist who is very frustrated because "I see so many young women with

TNBC and I have nothing for them"...I was heartened by this physician's level of caring. Another important

finding...but not from a randomized trial...was the effectiveness using cisplatin compared to taxanes. The study

was performed in Poland and presented by Dr. Jacek Gronwald the director of the program at a Polish hospital.

The n in the study was 10 and there was a complete clinical response in 9 of the patients. Again, I must stress that

this study was not performed under clinical trial guidelines but I found the presentation fascinating so much so

that after the session I spoke to Dr Gronwald and invited him to dinner. That is why I missed the session in the

ASCO lounge which I had particularly wanted to attend because I am a big Judy Garber fan. What I am about to

write is sort of an extension of the regular session. Jacek and I wound up having a 3 hour dinner and I believe we

will become friends. I know that sounds crazy but that's how I feel. He explained that in Poland, every woman

who has ovarian cancer or breast cancer is tested for the BRCA mutations that are known in Poland. Most

interestingly one of the Ashkenazi founder's mutations is one of the main mutations in Poland even though there

are virtually no Jews in Poland. Jacek has done work on this and it seems that in the 8th century there was a large

Jewish influence in Poland and much intermarriage and the mutation has been handed down for over 1200 years.

Fascinating..

Messages I will take to my constituency: Women should talk to their oncologists about exploring one of the PARP

clinical trials and also should talk to their oncologists about replacing AC/TAXOL with another chemo cocktail

possibly using cisplatin.


Explain: as I wrote previously the textbook and webinars have helped lay a foundation for me to better

understand what is being said in this case especially regarding DNA and the concept of DNA repair..

Additional topics: As I have written before I wish I had a better basic biology background. I have more work to do

and I will do it.

stephen kandel Session Info: 12:00:00 AM Genetic Testing and Society education Hours credit: 1.25

Presenter1: Excellent Presenter 2: Excellent Presenter 3: Very good Presenter 4:

Comment: I have a particular interest in this topic and feel I am well versed.

Significant findings reported: The most significant finding was the fact, as expressed by Ken Offit (who I have

seen on behalf of my daughter), that Memorial Sloan Kettering Cancer Center is initiating a program where EVERY

woman dx with ovarian cancer will meet with a Certified Genetic Counselor and the test for the BRCA gene

mutation will be recommended. also, I am very interested in Lynch Syndrome and I don't know that it is new

news but it was for me that Lynch Syndrome women have a higher risk of endometrial cancer than colon cancer.

I also found out, to my great sadness, from a comment from the audience (by an Armed Forces medical

professional) that the new GINA bill specifically excludes members of the Armed Forces from the bill so that many

members of the Armed Forces are not having genetic testing because they will be drastically disadvantaged if

their mutations become known. This is a disgusting policy and Ken Offit, one of the authors of the bill, was

amazingly unaware of this and promised to look into it.

Messages I will take to my constituency: I have already reported the ovarian cancer testing to the FORCE

community and have received several responses on the topic. MSKCC estimates that 10% of ovarian cancer

patients will turn out to have a BRCA mutation and this is tremendously important regarding breast cancer for



these women and their families.. also, I am going to discuss the lack of oversight and misinformation coming out

of unregulated SNPs tests.


Explain: the Genomics in Cancer book was a perfect primer for this session. Thank you!

Additional topics: I would like to know more about PGD.

stephen kandel Hours credit: 13.35



Craig Lustig Session Info: 5/30/2009 Economics of Cancer Care: It's Everyone's Problem 143



Comment: This was a very interesting and timely session. I learned a lot about the particular challenges of cancer

care in health reform efforts.

Significant findings reported: Cancer care in the US is a relatively small part of overall healthcare spending, but

spending on cancer drugs is increasing more rapidly than for other diseases. The high cost of cancer care widens

disparities, with some patients delaying treatment. US wage growth has been flat, in part because of increased

compensation in the form of health insurance. At the same time, premiums have risen, and there has been a

decline in the number of people with insurance coverage. Treatment intensity (volume) accounts for a significant

part of health care cost increases. It's difficult to control volume, and easier to control prices. There are

significant differences in practice and volume in health care expenditures.

Messages I will take to my constituency: It's important that health reform produce a system that focuses on

providing screening, diagnosis and treatment that actually contributes to a patient's health. It's critical to reduce

the utilization of services that don't improve health outcomes.


on this topic)

Explain:

Additional topics: What are the various proposals under consideration by Congress for reforming healthcare and

how do they differ?

Craig Lustig Session Info: 5/30/2009 International Cancer Outcome Disparity: What Do We Owe Our

International Colleagues? 151 Education Hours credit: 1.25


Comment:

Significant findings reported: Tobacco is the most preventable cause of cancer death. The impact of tobacco-

related cancer death falls largely on people in their middle age. Alcohol and BMI (both underweight and

overweight) present significant cancer risks globally. Cancer represents an increasing problem with an aging

worldwide population and introduction of cancer risk factors. The mortality rate from pediatric cancer is much

higher in the developing world, but integrated approaches to ensure adequate diagnosis and treatment of

childhood cancer alongside of other childhood diseases can significantly improve outcomes. Doctors who smoke

are less likely to counsel their patients to stop smoking.

Messages I will take to my constituency: There is a significant disparity in outcomes for childhood cancer patients

between the developed and developing world. There are proven strategies for improving timely diagnosis and

access to treatment for childhood cancer patients in poor countries.


on this topic)

Explain:



Additional topics: What are the global health and cancer organizations that are working in the developing world?

Craig Lustig Session Info: 5/31/2009 Translating Translational Research into Practice 189 Education Hours

credit: 1.25


Comment: This session was helpful in understanding the opportunity and the complexity in translational

research.

Significant findings reported: If academia and pharmaceutical companies work in parallel, clinical trials can be

initiated sooner. Using molecular diagnostics can be an important tool in making therapeutic decisions that will

provide treatments to patients that are targeted to their specific disease. Cancer drugs represent 40% of

Medicare drug costs. Improving the cost-effectiveness of cancer drugs can be achieved by decreasing use of

"futile drugs," and decreasing costs of toxicity.

Messages I will take to my constituency: Translational research presents the opportunity to improve outcomes

and reduce unnecessary morbidity for cancer patients. Advocates need to encourage researchers and

pharmaceutical companies to use available tools and work cooperatively to develop the best therapeutic options

for patients, customized to their particular molecular profile.


Explain:

Additional topics: What are the barriers to getting all parties involved in therapy development to work together

more effectively.

Craig Lustig Session Info: 5/31/2009 Rare Tumors in Childhood 112 Education Hours credit: 1.25

Presenter1: Very good Presenter 2: Very good Presenter 3: Barely understood Presenter 4:

Comment:

Significant findings reported: The Children's Oncology Group has a rare tumor subcommittee. There are

significant challenges in getting newly diagnosed rare malignancies registered with the COG tumor registry. An

interesting initiative is attempting to incentivize physicians to register rare tumors and provide tissue for banking.

Success has been achieved in studying rare childhood tumors in Italy through a network of centers applying a

common framework and dedicated support.

Messages I will take to my constituency: Advocates need to encourage clinicians to participate in registries and

research mechanisms in order to advance knowledge and treatment. There are models that provide examples of

how to accomplish research in rare tumors.


Explain:

Additional topics: How are the issues of rare tumors being addressed in other disease areas.



Craig Lustig Session Info: 6/1/2009 Understanding and Targeting the Tumor Microenvironment 193


Presenter1: Barely understood Presenter 2: Way over my head Presenter 3: Presenter 4:

Comment: This was a very challenging session for me to understand. There were numerous terms used by the

presenters that made it more difficult.

Significant findings reported: The relationship between inflammation and cancer is well-established. Bone

metastasis is a challenge in both adult and pediatric cancers.



Explain:

Additional topics: It would have been helpful to have a glossary of the terms used in the session.

Craig Lustig Session Info: 6/1/2009 ASCO/ESMO Symposium: Global Clinical Trials - Challenges and

Solutions 218 Special Session Hours credit: 1.25


Comment:

Significant findings reported: Building larger cohorts, through global clinical trials, can be beneficial to advancing

research. We are facing accrual challenges due to the increased number of disease subtypes. There are

differences in how clinical trials are supported and conducted, making collaboration difficult. Bureaucratic inertia

and a lack of standards for trial design represent key challenges. Global industry-sponsored trials are much more

common than ones sponsored by governments.

Messages I will take to my constituency: Global clinical trials hold great promise for accomplishing important

research more rapidly. Global trials sponsored by pharmaceutical companies hold lessens for government.

funded trials and advocates should challenge government to focus on resolving the barriers to developing more

global trials.


Explain:

Additional topics: Where is information about international trails available to share with patients. Are there

advocacy groups working on the barriers to getting greater cooperation between countries to support global

trials.

Craig Lustig Session Info: 6/1/2009 Genome-wide Association Studies and Pediatric Cancer 109


Presenter1: Good Presenter 2: Barely understood Presenter 3: Barely understood Presenter 4:

Comment:



Significant findings reported: Neuroblastoma represents an important problem in pediatric cancer, with only

incremental progress. Understanding the genetic basis of the disease will provide important diagnostic and

treatment opportunities. Getting detailed information about the patient and disease specifics in that patient is

critical to developing gene-specific relationships that can help inform treatment.

Messages I will take to my constituency: Neuroblastoma is a complex disease where that has been limited

progress in treating patients. Genome-wide association studies provide an important opportunity to develop

detailed understanding of the disease and impact diagnosis and treatment. Research is looking at potential

genetic differences in races that affect disease interaction with the patient. Research is not focused on producing

a genetic test.


Explain:

Additional topics: The potential for a clinical trial with new understanding of genetic information was discussed.

More information about how long it takes to bring this discovery into a trial, and how advocates can help to

support this effort would be helpful.

Craig Lustig Session Info: 6/1/2009 Systems Biology, Cancer Therapeutics, and Personalized Medicine

172 Education Hours credit: 1.25

Presenter1: Very good Presenter 2: Good Presenter 3: Barely understood Presenter 4:

Comment: I found the concepts around systems biology and application to cancer understandable, but the

specific examples presented by presenters 2 & 3 were difficult to understand. Presenter 3 seemed to assume the

audience already had considerable knowledge on th

Significant findings reported: The application of a systems biology approach to cancer provides an opportunity to

advance cancer prevention, diagnosis and treatment. Use of this approach in management of cancer may allow

the use of therapies that are not effective for the whole population of patients with a particular disease to be

successful in treatment a sub-group of patients. Systems biology presents the opportunity to target therapy to

repair DNA damage in patients whose disease is well-characterized. The complexity of the systems is a significant

challenge in cancer and developing integrative models will take time.

Messages I will take to my constituency: A systems biology approach to cancer may provide the ability to better

target therapies based on the genetic profile of the disease in the individual, develop combination therapies that

will have greater efficacy, and reduce the use of treatments that will not benefit the patient. Systems biology

models will allow the development/testing of new therapies with smaller patient populations. This promising

field requires collaboration between multi-disciplinary teams of researchers.


Explain:

Additional topics:

Craig Lustig Hours credit: 10.00



Pam Moffitt Session Info: 5/29/2009 Focus on Research 2009 Dinner Educational Hours credit: 0.50


Comment: Exciting speaker!

Significant findings reported: Genetic variations (different DNA) 1. Tumor is specific or a mutation 2. Host is

specific. Most common type of variation is SNPs. Inherited polymorphisms/mutations can increase cancer risk.

Angiogenesis is critical for tumor proliferation. The "Gail score" if the genotype effect.

Messages I will take to my constituency: That almost all treatments have side effects (adverse events) but most

are very treatable IE: Avastin causes "high blood pressure", Tamoxifen causes "hot flashes" and Aromatase

inhibitors have caused MS events, EGFR treatment causes a rash (lung cancer drugs like Tarceva) and

antiangiogenic therapy causes high blood pressure. But the side effects (adverse events) are treated and cancer

treatment continues.


Explain: The sessions on Genomics is making more sense now as we hear more and more about genes, genomics

and genetics.

Additional topics:

Pam Moffitt Session Info: 5/29/2009 Fundamentals of Clinical Trial Design & Methodology Clinical

Trials Hours credit: 2.25

Presenter1: Very good Presenter 2: Very good Presenter 3: Very good Presenter 4: Excellent

Comment: There were 5 speakers and he was very good also. I need to contact Dr. Steven Joffe to request a copy

of his slides. His presentation was excellent "Ethics in Cancer Clinical Research".

Significant findings reported: In Phase I trials the MTD (maximum tolerated dose) may not be the goal, the goal

s/b to identify the biologically effective dose (BED) which is based on surrogate end point or biomarkers. The

problem is the uncertainty about actual dose target. Two key issues with Phase II trials: effect of chance, effect of

bias which is controlled by: adequate randomization of patients, and using randomized treatment.

Randomization became the "gold" standard in 1940.

Messages I will take to my constituency: 81% of published trials are oncology studies. What is the "end point" of

the trials PFS (progression free survival or change in tumor size? An endpoint allows cross over during the trial. If

one of the arms is successful then everyone in the trial can be switched to that arm and it can all be done in 8

weeks time. For a look at Biometric research for new designs in Phase III trials go to: www.brb.nci.nih.gov


on this topic)

Explain: Clinical Trial info presented in past years.

Additional topics: Way aren't more researchers looking at Bayesian trial designs. Proving the negative hypothesis

is still hard for me to understand. Guess I'd rather prove something right than wrong.

Pam Moffitt



Session Info: 5/29/2009 Advanced Concepts in Clinical Trial Design & Methodology Clinical



Comment: Speakers always talk fast given they only have so much time to speak, but I have several pages of

notes so they where able to get their point across.

Significant findings reported: Problems with Integrated Phase 2/3 trials is 1. new drug is used w/other agents 2.

PFS is used as an end point. A non-inferiority trial aims to show the new drug is not much WORSE! That we do

interim monitoring on clinical trials to fix them: improve safety and improve conduct. And to sop a trial early if the

questions posed by the trial is clearly answered or the questions will not be answered in this trial.

Messages I will take to my constituency: We need to be able to control false positives better and ensure

confidentiality. That investigators often high-light the positives. We need to get more serious about monitoring!!


on this topic)

Explain: Information on Clinical Trials has been presented by RAN in past years.

Additional topics: Even though I do peer reviews I still want a better understanding of the entire process, that's

why I believe that survivors/patient advocates that are interests in clinical trial designs should be included in the

process from the "bench to the bedside"!

Pam Moffitt Session Info: 5/29/2009 Advanced Concepts in Clinical Trial Design & Methodology Clinical



Comment: Speakers always talk fast given they only have so much time to speak, but I have several pages of

notes so they where able to get their point across.

Significant findings reported: Problems with Integrated Phase 2/3 trials is 1. new drug is used w/other agents 2.

PFS is used as an end point. A non-inferiority trial aims to show the new drug is not much WORSE! That we do

interim monitoring on clinical trials to fix them: improve safety and improve conduct. And to sop a trial early if the

questions posed by the trial is clearly answered or the questions will not be answered in this trial.

Messages I will take to my constituency: We need to be able to control false positives better and ensure

confidentiality. That investigators often high-light the positives. We need to get more serious about monitoring!!


on this topic)

Explain: Information on Clinical Trials has been presented by RAN in past years.

Additional topics: Even though I do peer reviews I still want a better understanding of the entire process, that's

why I believe that survivors/patient advocates that are interests in clinical trial designs should be included in the

process from the "bench to the bedside"!

Pam Moffitt



Session Info: 5/29/2009 FDA ODAC Panel Meeting license app. BLA 125326 (Arzerra) for

CLL patients having has prior treatment Education/ Hours credit: 3.00


Comment: There were many speakers as the drug company (GlaxoSmithKline) had 4, the FDA had 1, and at 10:30

it was opened for a Public Hearing with questions to ODAC Panel and the ODAC discussion following.

Significant findings reported: Although the Advisory Panel gave their advice the FDA will make it's decision after

examining all available information. Drug in question is Arzerra (oftaumumab) for CLL patients having had prior

treatment.

Messages I will take to my constituency: The FDA holdings public meetings when ODAC and other group panels

convene to express their thoughts and research on a drug or device and if it should be approval for use or made

available for clinical use. However, the FDA does not have to take the panels advice IE: Feb. 2008 FDA approved

Avastin + paciltaxel contrary to FDA Advisory Panel being against using it for metastatic Breast Cancer.


on this topic)

Explain: Materials given out at meeting

Additional topics: Since I am an ODAC member it was educational for me to listen to this discussion and observe

the process so that when I have an Advisory Panel for Lung Cancer I will know what goes on.

Pam Moffitt Session Info: 5/30/2009 Opening Session Special Session Hours credit: 2.00


Comment: 10th Anniversary, Special Awards to donors of the ASCO cancer Foundation. NCI Director Dr.

Niederhuber on NCI funding and "Patient-Centered Care"

Significant findings reported: Cost of human genome test in 30 times what insurance will cover, in 2009 the cost

is $100K by 2010 it will be $30K. Cancer- disease of the genes: mutations, translocatons. Tumors as "organ"

systems. Targetable tissue: NexGen sequencing $1K for genome testing in 5 yrs, Germline regions: Snps, Cgems;

high throughput profiling; systemically monitor Ribosomes; Single circulating cell capture & analysis through

many fluids. The pilot study includes: glioblastoma, ovarian and lung. In 2009 there were 100 FDA approved

drugs. "Personalizing Cancer Care" is Better Care at a Lower Cost. Personalized Cancer Care Program will treat

the person giving them access to quality care. Electronic Health Care Records are going to be very important

because by 2030 global cancer will triple and will be the leading cause of death in the US. In 1958 a CALGB was

the 1st clinical trial it was 8 pages long. Today I would say that most "Informed Consents" are that tlong. Many of

the peer reviews I have done are clinical trials that are 65-80 pages long. "To go fast - go alone. To go far - go

together"

Messages I will take to my constituency: Although the amount of money that the NIH received this year has been

increased it is not all designated for lung cancer but rather for lung health. We need to remember that COPD,

Emphazema are also lung diseases. As your Drs. (all of them) about clinical trials. They are not a last ditch effort

but rather a chance to take tomorrows' treatment today.


on this topic)

Explain:



Additional topics:

Pam Moffitt Session Info: 5/30/2009 ASCO Research Review Sessions for Patient Advocates

Research Review Hours credit: 0.25


Comment: My experience has been that the speakers of the "mentor sessions" have always been so eager to get

a presentation and more than willing to answer all our questions. Thank you!

Significant findings reported: Dr. Cooke: Some of the old chemos work better at the gene level; Higher PSA

counts on men >70 should be a watch and wait as 1/3 of them are overtreated. There are new oral agents in the

pipeline. MTOR links all pathways. Dr. Garlowe: SIP2D6 treated w/Tamoxifen and new genetic test soon.

MIRROR trial = .2mm cancer cell in lymph nodes with no treatment equates to more recurrences. Cancer stem

cells can survive chemo so that it can still spread, need to identify those who have those cells. Dr. Obel: Avastin

used for early stage colon cancer, when used with FUL Fox it doesn't improve DFS when Avastin is stopped. Rectal

Cancer using 5FU + Radiation & surgery. Oxcellipatinum has no direct effect. Anal cell using chemo & radiation.

Herceptin is being used with Gastric cancer. Colon cancer: if it is metastatic it is often better to leave the colon

tumor intact and treat the mets.

Messages I will take to my constituency: Treatment changes are happening all the time, just because something

used to work on most people does not mean it has to be used on all the patients of that cancer type. We are

headed into treating the person and how they react to certain drugs and not relying on the "old way".


on this topic)

Explain:

Additional topics: More about colon cancer because there is a very high family history of it. But Kate M advised

that I contact a Genetic Counselor

Pam Moffitt Session Info: 5/31/2009 Scientific Mentor Session for Patient Advocates

Mentor/Educational Hours credit: 1.00


Comment: Thank you for including a "Thoracic" Oncologists! I, personally, appreciate all the Drs. that are part of

our "mentoring" but, am always thrilled to see that there is a Dr. in the lung community presenting.

Significant findings reported: Dr. Bruce Johnson: There are 4 studies this year, 3 of which are studies in

"maintenance": Tarceva, Avastin, Alimta, non of which can be used if the cancer is NSCLC Squamous cell. 80% of

NSCLC are adeno cancer. After 10 yrs of survival there is a greater risk of thyroid cancer, but, 28 % of the patients

will be hypo thyroid. The other drug in "Targeted Therapy" trial is "Zactima" which blocks EGFRs and slows the

recurrence by 38%. Dr. Sandler: They were wrong to use HT (Hormonal Therapy) to treat advanced prostte

cancer.Immuno therapy=vaccine made in a virus, that then attacks PSA>Now, those who were given the drug and

then were followed longer term are living longer. Dr. Judy Garber. treatment for breast cancer doesn't fix the



DNA. For triple negative the chemo needs to be more effective. A study in Poland BRAC1 75 % of the women

had tumor redection

Messages I will take to my constituency: Although most drugs in trials now are not for squamous cell patients

there is hope because of the increase in targeted therapies that are being studied. Studies have shown that

Tarceva is less toxic and reduces recurrences but 30%, Avastin, is less toxic that older drugs and Alimta because it

is an oral drug can be given for a long time and is also less toxic.


Explain:

Additional topics:

Pam Moffitt Session Info: 6/1/2009 Keys to Speaker Success (Or How to Talk Good) Professional

Development Hours credit: 1.25

Presenter1: Excellent Presenter 2: Very good Presenter 3: Good Presenter 4:

Comment:

Significant findings reported: Geo. Sledge, MD: Stay on time, know they WILL ask questions, be organized,

accurate. Practice speech in front of your peers. Share with co-author, know how to run your slides. Know your

discussant! Avoid "Death by PowerPoint" don't get carried away with it. Don't read your slides! Make sure font is

clear and large enough they can read it in the back.Don't waste time on title slides, let audience read disclosures.

Limit intro to 2 minutes. Know your subject and don't rush through data. "You aren't through when you are

through." Jay Harris, MD: Tell a story, prepare 1-3 points you want to make. There is more of a chance to be as

creative as you want BUT stress the basics. Know your audience, consider what other speakers will say.

Summarize at end. Tell them what you will say, say it, tell them you told them. Simplicity is ultimate. Don't rush,

practice, don't overwhelm them. Monica Marrow, MD: 10. Be prepared, 9 - 2 Be prepared, 1. Be prepared, get

data together. Have rough draft ready 1 month ahead. Write manuscript, don't talk down to audience. Focus in

areas with data. KISS - Keep it simple - stupid!!

Messages I will take to my constituency: Jane Perlmutter once told me I blew her away the 1st time she heard

me speak at NCCTG. I was scared to death as Cynthia was the only one I knew and she was in the hospital. But I

know I have a lot to learn. And although this session was also named "Your 15 minutes of Fame" it still applies to

all speeches regardless of time.


on this topic)

Explain:

Additional topics:

Pam Moffitt Hours credit: 14.75



jeff newbauer Session Info: 5/29/2009 Fundamentals of Clinical Trial Design & Methodology 267


Presenter1: Very good Presenter 2: Very good Presenter 3: Good Presenter 4: Excellent

Comment:

Significant findings reported: I was surprised to hear the degree of bias inherent in clinical trial design and the

issue surrounding the lack of standardization of methodology, clinical validation, weakness in patient accruals and

general lack of concurrent controls in trial design. Phase 0 trials – very limited drug exposure (1/100th of phase

1 dose), no therapeutic of Dx intent. Purpose of phase 0 trial is to improve efficiency of subsequent trials Phase I

trials – Evaluate new therapy in humans or new combinations of therapy. Goal is to identifying dose limits and

the maximum tolerated dose. Understand drug metabolism in humans. Start with safe dose and build up

depending on toxicity encountered in patient. Two designs – conventional 3 + 3 design start with three patients

assess and add three additional patients – relatively safe and provides good phase 2 dose. Continual

reassessment method – uses a statistical approach to increase dose. Phase 2 trials – exploratory and start to

measure efficacy - conducted on specific diseases. Goal is to maximize the chance of an accurate conclusion on

treatment. Designs – single arm & randomized. Phase 2 provides a go/no go for phase 3 trial. Very few phase 2

trials move to phase 3. Randomized trials – why randomized. Avoid bias in assigning treatments, standardize

patient enrollment and provide control group. Control group may use placebo control – only if no standard exists;

standard control – to compare new treatment to current standard treatment. When drawing conclusions be

careful of the Simpson Paradox – drawing conclusions from a large data set when the opposite conclusion could

be draw from examining the unequal smaller data sets. Ethical issues Criteria for ethical research – 1) social

value; 2) scientific validity; 3) fair subject selection; 4) balance risk / reward; 5) independent review; 6) informed

consent; 7) respect for patients. Clinical trials should have a scientific intent (therapeutic intent may be a benefit

in 5% to 10% of the time) - Clinical trial participants often over estimate the therapeutic benefit from joining a

phase 1 trial. Phase 2 trials should be a precursor to phase 3 trials however study shows very few make it to

phase 3 – often due to 1) legitimize a non standard treatment or 2) improve the CV of the investigator.

Historically 70% of the randomized phase 3 trials were funded by cooperative groups now 70% are funded by

Pharma companies (might be a problem). Phase 3 trials should have clearly stated primary endpoint of benefit to

the patient – 1) survival; or 2) quality of life/symptom control. In a review of 510 abstracts describing randomized

clinical trials only 22% had a clear primary endpoint and 17% identified the source of funding.

Messages I will take to my constituency: This session provides excellent background of clinical trials and

highlights some of the key biases and concerns surrounding the design of clinical trials. Based on the information

presented there are several areas for us to focus on in developing our education materials - 1) patients need to

understand the risk / benefits of participating in clinical trials and help them to understand the limited

therapeutic benefit typically found in phase 1&2 trials. 2) help patients evaluate the primary endpoint of the trial

to be certain there is some improvement in survival and / or quality of life. 3) encourage participants to pay

attention to the source of funding for the trial which may create a potential bias


on this topic)

Explain:

Additional topics: review of basic statistics - Chi square value



jeff newbauer Session Info: 5/29/2009 Health Care Economics & Quality 263 Extended Education Hours credit:

2.25

Presenter1: Very good Presenter 2: Excellent Presenter 3: Good Presenter 4: Excellent

Comment:

Significant findings reported: There is a tremendous degree of disparity that exists in health care and cancer care

in particular. There are many factors that contribute to this disparity including lack of insurance coverage,

transportation, language barriers and poor supply of medical service. There is a larger disparity among minorities

and the poor regarding access to care and also disparity in treatment. This often leads to more advanced disease

at dx and ultimately higher costs of care. Studies show 27% of patients do not get cancer care due to cost and

33% of families cannot pay cancer related bills. A Rand study also shows the US population receives on average

only 50% of the recommended services. These access issues result in less maintenance and prevention care and

leads to more advanced disease at Dx. Better health care has traditionally been associated with higher utilization

of services and higher cost – however there is evidence that more services can actually lead to poorer outcomes.

The Dartmouth Atlas of Health Care shows very large variations in US health care expenditures by geographic

region. Those same variations in cost are also correlated to huge variations in health care resources (hospital

beds, physicians, specialists etc.) with no corresponding difference in need. These variations can be three to four

times between the lowest area to highest with no improvement in outcomes. Patient induced demand (war on

cancer – patients and advocates tend to demand more aggressive care) may be a factor in contributing to the

variations. However patient demand is not likely to have a significant impact. This begs the question … is the over

supply of services leading to higher cost? Higher intensity of service not only doesn’t lead to better outcomes

too much care may actually be harmful. E Fisher study showed in regions with the greatest hospital capacity per

capita also had an increase risk of death. Higher intensity of care intends to provide early detection and possibly

less invasive treatments however studies show the unintended consequences of high intensity care create too

many false positives and excess complications due to over treatment. In spite of all the new technology,

increased spending per capita and utilization of services cancer there has been very little improvement in

outcomes (death rate) in cancer compared to other countries. Compare to the advancements in heart disease

which has shown significant improvement in death rates over the last 30 years. There are wide variations in

guidelines that provide some incremental improvement but at significant increase in cost – and many treatments

/ screening have no effect on outcomes. More evidence based standards need to be implemented but

unfortunately the data is not routinely collected. One interesting point on reimbursement from CMS – CMS will

consider reimbursing a questionable treatment or screening regimen provided the provider participated in

collecting the data to support thorough study.

Messages I will take to my constituency: Our focus is on disease prevention and early detection and our

programs will be designed to educate young adults on what to do to take charge of their health. This session

exposed some of the variations that exist in the standard of care and the guidelines for surveillance. More

importantly many of the guidelines in practice are or may not lead to improved outcomes. Advocates can be an

important voice in modifying behavior in the populations they serve – we have a responsibility to make certain

the messages are accurate and evidence based.


on this topic)

Explain:




jeff newbauer Session Info: 5/30/2009 Genetic Cancer Risk Assessment within the Community Oncology

Practice 136 Education Hours credit: 1.25


Comment:

Significant findings reported: 5% to 8% breast cancer and 2% to 5% colorectal cancer are attributed to a

hereditary factor that can be identified. Family history must cover 4 generations and this requires physicians to

have patience and obtain the data over several visits. There is a distinction between genetic risk assessment and

genetic testing. Risk assessment is the process of identifying the risk of carrying a genetic mutation typically

acquired through family history. Genetic testing is offered to those patients whose risk justifies the genetic test.

Providers are responsible for understanding the ELSI ethical, legal, social and insurance issues surrounding genetic

testing and they are required to provide quality genetic care and counseling to their patients. Timely &

appropriate identification of at risk patient is the biggest obstacle – physicians (and oncologist) generally

underestimate the risks and prevalence of inherited mutations. Physicians don’t take adequate family history and

don’t consider hereditary cancer in young patients. The traditional model takes a long time and requires

coordination between a physician and genetic counselors – physician refers a suspicious patient to a genetic

counselor. Unfortunately less than ½ actually visited the genetic counselor. Consequently less than 5 % of

inherited mutations are found. Suggestion in this session – perhaps the oncologist is in a better position to

perform genetic counseling. The oncologist is in the best position to handle risk analysis and guidance in

managing the patient’s options and coordination of care is much more efficient. Also the new model provides a

significant improvement in identifying high risk patients with inherited mutations. Risk assessments require more

of the physicians time and taking a family history involves more than simply asking “do you have cancer in your

family”. Cancer risk assessment requires multi-disciplinary team and academic health centers can partner with

community oncologist which allows them to take full advantage of the resources at the academic health center.

The academic health center gains information from the community to provide further study and ultimately

improve the screening guidelines.

Messages I will take to my constituency: Our organization’s focus is on disease prevention and early detection

and our education programs will be designed to educate young adults on what to do to take charge of their

health. For us this session highlights some of the difficulties physicians face in identifying patients with inherited

mutation. Accurate family history is an important first step in identifying these patients. Our goal is to educate

young adults on the importance of knowing their family history and more importantly we will develop tools to

facilitate young adults gathering their family medical history. Further, we will also help our young adults

efficiently transfer that family history to their physicians – hopefully simplifying and speeding up the initial

genetic risk assessment.


Explain:

Additional topics:

jeff newbauer Session Info: 5/30/2009 Genetic Testing and Society 124 Education Hours credit: 1.25



Presenter1: Good Presenter 2: Very good Presenter 3: Very good Presenter 4:

Comment:

Significant findings reported: There are several Lynch syndrome surveillance recommendations – colonoscopy

every 1 -2 years beginning at age 20 for mutation carriers (MLH1), 25 (MSH2) and 30 (MSH6 & PMS2);

Endometrial sampling every year beginning at age 30; transvaginal ultrasound every 1 -2 years beginning at age

25. Study shows improvement in outcomes for those receiving colonoscopy every three years. Family history is

key to Dx Lynch syndrome cancer. Family history can be deceiving – family size is getting smaller and frequent

colonoscopy is preventing many colon cancers. Some of the current guidelines/criteria would miss 25% to 50%

patients with Lynch syndrome; ie 50% of colon cancer patients with Lynch syndrome are Dx over age 50

(guidelines recommend screening under age 50) 24 % of colon cancer patients with Lynch syndrome do not meet

family history criteria. There is an explosion of direct to consumer genetic testing companies taking advantage of

the hype of personalized medicine. However much of this is not evidence based and is not followed up with a

genetic counselor. Consequently the consumer walks out with wrong information. Plus there is inconsistency

among companies who provide genetic screening some actually reporting opposite results. There are no

standards in process or algorithms between these direct to consumer companies. Oversight of genetic testing is

needed – FDA does not regulate genetic test because they are lab developed – the CLIA regulations apply to labs

but not the genetic test – and the FTC provides oversight for advertising but not the genetic test. Genetic

counseling can be used to facilitate informed consent however there are challenges as the number of test

increase. Direct to consumer tests are growing but few provide clinician or pretest counseling. Direct to

consumer test generally do not disclose the risk or limitation and they tend to overstate the benefits of genetic

testing. Informed consent is necessary when the risks are high for; stigmatization; family discord and

psychological distress.

Messages I will take to my constituency: The focus of our organization is to assist young adults in taking charge

of their own health care. Part of this education process will include tools to help young adults collect and record

complete and accurate medical history. In addition we also plan on helping our young adult members spend their

health care dollars wisely – we will also provide education tools to evaluate the proper use of genetic testing.


Explain:

Additional topics:

Jeff newbauer Session Info: 5/31/2009 Plenary Session 1 plenary Hours credit: 3.00

Presenter1: Very good Presenter 2: Good Presenter 3: Good Presenter 4: Barely understood

Comment: This session had 5 presenters/discussion - Norman Wolmark & Lee Ellis - very good understanding

Significant findings reported: Cancer is complex and problematic because each tumor is unique. 99.9% of genes

in a cancer cell are identical to normal cells and of the 40 to 100 mutations found in cancer cells only 3 or 4 of

those mutated genes are common between tumors in different patients. No two cancer patients are the same.

Only a fraction of the mutations- roughly 20%- are “drivers” remaining mutations are neutral. Drivers either

cause a cell to be “born” more than it should or “die” less than it should. Only 12 to 15 mutations are drivers and

the difficult task is to id the driver mutations. A simpler approach may be to look past the gene and focus on

Pathways because Pathways are limited (saturated). There are no more pathways to be identified – scientists



have discovered new genes but no new pathways. Future drug development may be better served to focus on

pathway targeted drugs (effective in most forms of cancer) as apposed to gene targeted drugs which are limited

to fewer types of cancer. Cancer Predisposition accounts for relatively small fraction of all cancers however they

often affect younger patients more and they can be preventable. In small families with a possible predisposition

to a particular cancer it may be beneficial to sequence all of the genes in normal cells to predict and detect

tumors early. Early dx - it takes a relatively long time for the mutations to accumulate enough to cause

metastatic cancer - about 30 years. Patients that die from cancer do so only because the tumor was not detected

in the previous 27 years. One way to detect the tumor early (in the future) is to look at DNA molecules one at a

time to identify the number of mutate molecules and literally count them - Digital genomics. There is promise in

colon cancer by looking for mutant molecules in blood for early stage colorectal cancer the test can successfully

detect 50% in blood and 90% in stool. Most important point here is not what is found but what is missing – there

are no mutant molecules in normal samples. These test could be used as markers for health. Rustin – 80% of

patients with advanced ovarian cancer will relapse after first line chemo. Trial was conducted to determine if

there is an improvement in survival with early treatment. Conclusion - There is no difference in survival

depending on early or late chemotherapy. Furthermore early chemotherapy contributed to poorer quality of life.

Therefore there is no benefit for early detection of relapse by routine CA125 surveillance – (most) patients may

benefit more if chemo is delayed until signs & symptoms occur. Patients now have informed choice. Schuster –

lymphoma 6th most common cancer and Follicular lymphoma is the 2nd most common subtype. Id-KLH

vaccination does seem to improve disease free survival in patients but only for those in complete remission at the

time of vaccination. One limiting factor facing vaccines is the time it takes to produce the vaccine. There is

promise for a number of improved technologies to produce the vaccine more rapidly. Wolmark – (By far the most

entertaining presentation). The addition of Bevacizumab did not result in significant improvement in 3 year

disease free survival for patients with stage II & III colon cancer. Bevacizumab may have a transient benefit in

disease free survival only while the bevacizumab was administered. The use of Bevacizumab for longer periods

along with chemo may prolong improvement in disease free survival but is it worth the additional cost.

Messages I will take to my constituency: Many of the messages in the plenary session were focused on specific

diseases. The role of our organization is to focus on healthy young adults and keep them healthy by making them

aware of hereditary and lifestyle risks that can lead to disease. The information in this session provides our

organization with excellent background information to help us build our case for support. Of particular interest

was Bert Vogelstein’s presentation. His simplified explanations of gene mutation will be extremely helpful in

communicating to our constituents. Also his comments on cancer predisposition in small families provide us with

information to make a strong case for our education programs as well as supporting our early detection and

screening advocacy.


Explain: The materials in this course were extremely helpful, especially for Bert Vogelstein’s presentation.

However the presentation and discussion on PARP Inhibitors by Merrill Egorin & Joyce O’Shaughnessy was

challenging and very difficult to follow.

Additional topics:

Jeff newbauer Hours credit: 10.00



Merel Nissenberg Session Info: 5/29/2009 Advocate Institute Focus on Research Dinner Presentation Dinner

Presentation Hours credit: 1.00


Comment:

Significant findings reported: Discussion of SNP's as the most common variation. Looking at biomarkers can

involve looking at the tumor itself (tumor-specific mutations) or looking at host-specific differences

Messages I will take to my constituency: Biomarkers development is critical to finding ways to cure and possibly

prevent cancers


on this topic)

Explain:

Additional topics: As a member of EDRN I plan to learn all that I can about bio-markers

Merel Nissenberg Session Info: 5/29/2009 Maintenance Chemotherapy in Advanced NSCLC Education



Comment:

Significant findings reported: Pros and cons of maintenance chemo for NSCLC. Progression Free Survival

increasingly accepted as endpoint (it has clinical benefit) but hard to measure. There is maintenance;

continuation of original platinum-based chemo; continuance of the single agent without platinum; or

consolidation with new agent

Messages I will take to my constituency: Still disagreement on maintenance chemo for NSCLC. Dr. Einhorn's

overview on the differences is enlightening


on this topic)

Explain:

Additional topics: Just continuing to read up and hear presentations on new studies

Merel Nissenberg Session Info: 5/29/2009 Locally Advanced Non-Small Cell Lung Cancer Education Hours

credit: 1.25


Comment:

Significant findings reported: Looking for optimal chemo regimens. There are 3 significant hopeful EGRF

Inhibitors - TKI's. 40-80% of NSCLC have overexpression of EGRF.



Messages I will take to my constituency: The optimal chemo regimen for NSCLC remains to be determined; there

are many studies being conducted at the present time (primarily through RTOG and CALGB).


on this topic)

Explain:

Additional topics: I understand a lot about lung cancer but new studies about new modalities and treatment

regimens change all of the time and I want to find out about them.

Merel Nissenberg Session Info: 5/30/2009 Genitourinary (Prostate) Cancer Oral Abstract Session Hours credit:

2.50


Comment: The 2 Co-Chairs were excellent.

Significant findings reported: PSA Doubling and Gleason score are the most important predictors of progression

and mortality. Dr. Stephenson said that after 35 years, Gleason grade remains the most important prognostic

marker. Treatment doesn't need to be curative to be effective. It's important to integrate disease heterogeneity

and co-morbidities.

Messages I will take to my constituency: Consider which patients should not be treated (or immediately treated)

for prostate cancer


on this topic)

Explain:

Additional topics:

Merel Nissenberg Session Info: 5/30/2009 Local Prostate Cancer Therapy: What The Medical Oncologist

Needs to Know Education Session Hours credit: 1.25


Comment:

Significant findings reported: Still mixed messages/feeling about early detection of prostate cancer

Messages I will take to my constituency: AUA New PSA Guidelines may need to instruct physicians on how to

react to findings at Age 40


on this topic)

Explain:

Additional topics: We need to convince the USPSTF of the need for early detection of clinically significant

prostate cancer



Merel Nissenberg Session Info: 5/30/2009 Lung Cancer - Local-Regional and Adjuvant Therapy Poster

Display/Discussion Session Hours credit: 1.00


Comment:

Significant findings reported: need to personalize therapy especially in early disease. Good quality resection is

important. RADIANT trial of adjuvant Tarceva - validates mountain data.

Messages I will take to my constituency: Personalized medicine is crucial: using biomarkers, pharmacodynamic

factors, as well as predictive and prognostic factors


on this topic)

Explain:

Additional topics: More studies are in progress; I want to follow them or as many as is practicable

Merel Nissenberg Session Info: 5/30/2009 The New Staging System: What Does It Mean? Education



Comment:

Significant findings reported: There will be a new Staging System presented July 2009 building on the one

developed by my husband, Clifton F. Mountain, M.D.

Messages I will take to my constituency: the New Staging system will refine some of the data gathered and will

building upon the Int'l Staging System last presented June 1997


on this topic)

Explain:

Additional topics: I will learn the refinements in the new Staging System at the World Conference on Lung Cancer

July 2009

Merel Nissenberg Session Info: 5/31/2009 Prostate Cancer Prevention and Screening Education Session Hours

credit: 1.25


Comment:

Significant findings reported: Risk of death from prostate cancer may be related to differences in access to

screening. PCPT Trial: great benefit. Finasteride appears to reduce incidence of low-and high-grade P ca. It also

improves diagnostic accuracy of PSA. SELECT Trial showed no benefit to selenium and Vitamin E.



Messages I will take to my constituency: Finasteride may be a key to treating BPH and/or preventing prostate

cancer


on this topic)

Explain:

Additional topics:

Merel Nissenberg Session Info: 5/31/2009 Genitourinary (Prostate) Cancer Poster Display/Discussion Session

Hours credit: 1.00


Comment:

Significant findings reported: PSA is still a valid marker for screening but we need new threshold levels. PCA3

appears to be an exciting new marker

Messages I will take to my constituency: Watch for PCA3 to become the important new marker for prostate

cancer diagnosis


on this topic)

Explain:

Additional topics:

Merel Nissenberg Hours credit: 11.75



Susan Samson Session Info: 5/29/2009 Integrating Molecular Tools into Clinical Practice: Individualizing

Treatment for Breast Cancer Education Hours credit: 1.25


Comment: I was familiar with the topics discussed and felt that the sessions were informative and provocative.

Significant findings reported: Molecular markers assessments require rigorous validation and analytic reliability.

Consideration must be given to clinical utility, and cost effectiveness. Key questions: Does the marker add

anything beyond that which is already known? Does it address the rampant statistical problems dealing with

samll sample size and over analysis? Gene signatures are primarily useful in identifying luminal A like ER+

tumors where chemotherapy could be avoided. Tumor stage is an independent prognostic marker which must

not be ignored.

Messages I will take to my constituency: To understand this topic consideration might be given to the following

questions: What was tested? Was study a developmental or validation study? Are analytic and reproducibility

data available? What will be done with the information? Key messages: No data from prospective

randomized trials to support changing therapy on the basis of changes in tumor mafkers. Important to do serial

assays to capture characteristics of CTC phenotypes. Prospective data to support changing therapy on basis of

CTC enumeration are pending Intrinsic molecular classification of breast cancer subtypes have clinical

implications. There is no direct evidence that gene expression profiling will lead to improvements in outcomes.


Explain: Handbook and lecture series were very useful....Still looking forward to the Biomarkers session

Additional topics: How subtyping improves predictive accuracy -How- promising ideas for molecular markers are

often dropped because of study design complexities or validation issues.. A clearer understanding of the uses and

abuses of molecular tumor markers in the diagnosis

Susan Samson Session Info: 5/30/2009 Vitamin D Supplementation: Does It Have a Role in Cancer

Treatment and Prevention? Education Hours credit: 1.25

Presenter1: Very good Presenter 2: Good Presenter 3: Very good Presenter 4:

Comment: Controversial topic was handled well....lively discussion followed.

Significant findings reported: 25 Hydroxy D and clinical outcomes in post menopausal women: • Calcium

and Vit D supplements at a dose of 400 IU/day do not reduce invasive breast cancer incidence. • 25 OHD

levels mixed findings for association with breast cancer but BMI and physical activity are potential confounders •

25 OHD levels have conservative evidence of association with fractures • Vit D at 800-1,000IU/day

associated with a modest decrease in fracture risk • Premature to measure and treat 25 OH levels •

Supplements of 1,000 IU needed to raise plasma levels. Role of Vitamin D in breast cancer recurrence: •

Vitamin D experiencing explosion in breast cancer literature • Vitamin D associated with all cause

mortality, however it is not associated with cancer mortality. • What is new: Cyp27B1 enzyme facilitates

conversion of 25 OH vit D to 125 OH vit D---Impacts proliferation and differentiation (immune function and

regulation of hormone secretion)---Those deficient may be more susceptible to auto immune disease and

infection. • Insufficient data to conclude Vit D is casually associated with recurrence in BC. However, many

patients are deficient or insufficient. • As a result, increasing vitamin D levels to those associated with



optimal health and reduced mortality is a reasonable goal. Caution: Understanding of key cancer related

processes is critical. Clinicians must be careful about recommending large doses that will take blood levels higher

than the recommended optimal range of 90-100 nmol/L. While vitamin D levels are frequently deficient in

breast cancer patients, there is no direct evidence from randomized trials that vitamin D alters prognosis. In cell

culture, vitamin D alters phenotypes. Risk of death varies with season of diagnosis and latitude.

Messages I will take to my constituency: The session highlighted some notable controversies in the field.

Vitamin D deficiency is widespread---20-=30% are deficient; 50% are insufficient. A higher problem of deficiency is

seen in the obese, elderly, and those who avoid the sun. When is the most important time that vitamin D is

most critical? Adolescence and early adulthood may be most critical. Of note is the statistic that 50% of

premenopausal women at high risk for breast cancer are vitamin D deficient. It is likely that vitamin D does play

a role in preventing breast cancer, but the optimal level of dosage is still undefined. At present, try to achieve

250 HD levels of 30ng/ml --- for bone health and neuromuscular health. Vitamin D is associated with all cause

mortality, however it is not associated with cancer mortality


on this topic)

Explain:

Additional topics: This is a field of considerable controversy... Would like to know how Vit D deficiency and

supplementation affects breast cancer risk and progression across the full range of life stages. Would like an

evaluation of Vit D adequacy and would like to know

Susan Samson Session Info: 5/31/2009 ASCO/Radiological Society of North America Joint Session: Is this

Treatment Helping? Imaging Response in 2009 education Hours credit: 1.25


Comment: Wonderful informative session pointing to future therapeutic models.

Significant findings reported: Efforts to improve the accuracy and precision of imaging measurement tools,

anatomic response assessment, and the role of functional PET imaging in response assessment were discussed by

Dr.s Sullivan, Schwartz, and Wahl. Dr. Sullivan introduced the talk with the comment that tumor measurements

are the most widely used, yet least well understood biomarker in imaging. It is generally believed that effect is

directly attributable to shrinkage of the tumor. If tumor shrinkage occurs and the response is durable, then there

is a correlation with clinical benefit…i.e., survival. However, meta analysis shows that there may not be a strong

correlation between response and survival. RESIST criteria, improving acquisition, and advanced/enhanced

anatomic imaging techniques were discussed by Dr. Schwartz. The bottom line is that we don’t have a lot of

clarity regarding impact standards. Is confirmation needed? What about lymph node assessment, use in trials

and targeted therapy? Should the standard be based on functional instead of anatomic imaging? According to

Dr. Schwartz there is a role for anatomic based imaging in clinical trials and he points out that much has changed

with regard to measuring tumor burden, measuring progressive disease, and evaluating new lesions. What has

not changed is the fact that measurable lesions are still defined by unidimensional measurement, tumor burden is

based on the sum of diameters, and categories of response are still considered. Emphasis should be given to

the importance of standardizing techniques and improving image acquisition parameters for reproducibility.

Three areas were explored: selection modality, contrast administration, and slice thickness. In summary,

anatomic imaging has changed with regard to enhancement patterns and vascularity. Surprisingly, FDG PET and



modified RESIST performs similarly. Dr. Wahl discussed the current goal of individualizing treatments to

optimize response and minimize toxicity. He pointed out how imaging lets us see how phenotype behavior in the

patient operates in a physiological mileu. PET/CT techniques are intrinsically quantitative and the

standardization of analytic methods is required. If there are disparities between anatomical and functional PET

scans, usually the functional imaging scans are more accurate. Dr. Wahl pointed to several limitations. Using

this technique for lymph node assessments is troublesome, and it is often difficult to detect small tumor foci,

especially if surrounded by normal tissue. Furthermore, size criteria are not reliable, and PET is slow to predict or

display a response to therapy. He emphasized that a negative PET scan does not exclude cancer and a true

positive PET after two cycles suggests poor prognosis and unlikely cure. However, PET/CT enhanced imaging

appears predictive of outcome.

Messages I will take to my constituency: Imaging response has the potential to improve personalized cancer

treatment. In the future, the model will be that of response adaptive therapy. The initial therapy selection will

be based on tumor characteristics at biopsy and scan. A PET/CT or reproducible MRI will be given at baseline. A

PET/CT or reproducible MRI will be given after one cycle of therapy. If in a responding group, then treatment will

continue. If non responding, an alternative therapy, potentially dose intensive or clinical trial will be suggested.


Explain:

Additional topics: Overview of imaging techniques----the challenges and limitations of assessments.....the use of

advanced/enhanced techniques to predict outcome and guide therapy....

Susan Samson Session Info: 6/1/2009 Plenary Session including Science of Oncology Award and Lecture


Presenter1: Excellent Presenter 2: Very good Presenter 3: Excellent Presenter 4: Very good

Comment: Ratings refer to presentations of Vogelstein, Shuster, O'Shaughnessy, Wolmark

Significant findings reported: Of particular interest was the exciting results of the PARP trial reported by Dr,

O'Shaughnessy. Triple negatives compromise 15% of all cancers. While the majority of triple negatives do not

recur after adjuvant therapy, 30% develop metastatic disease. Although current treatment options are limited,

BRCA deficient cells are sensitive to PARP inhibition. PARP inhibitors improve results in double strand breaks.

Based on in vitro evidence of synergy between BS-201 and gemcitabine and carboplatin, gene expression studies

demonstrate that PARP 1 is upregulated in triple negative breast cancer. Treatment with BS201, a poly (ADP-

ribose) polymerse-1 (PARP -1) inhibitor in combination with gemcitabine/carboplatin was well tolerated in the

Phase II study and did not potentiate chemo related toxicities.. BS-20l significantly improved CBR, PFS, and OD,

compared with G/C alone. The promising safety and efficacy data from the Phase II study justifies investigation

of BS-201 in a Phase III study.

Messages I will take to my constituency: Triple negative breast cancers lack both ER and PR receptors and HER2

is not overexpressed. They also share molecular features with BRCA1/BRCA2 related breast cancers. These are

aggressive cancers; about 30% develop metastatic disease and the median survival after progression is 13

months. Although currently available therapies for metastatic triple negative breast cancer are limited, BS-201

in combination with gemcitabine and carboplatin is a novel targeted PARP therapy which improves patient

outcomes, including clinical benefit, objective response rates, median progression free survival and median



overall survival rates. The findings of the study suggest promising possibilities for the role of PARP inhibitors in

DNA repair and disease management.


on this topic)

Explain: Discussion of the topic was briefly addressed in Briefings

Additional topics: DNA repair deficiencies and PARP inhibition.

Susan Samson Session Info: 6/1/2009 Systems Biology, Cancer Therapeutic, and Personalized Medicine



Comment: Wonderful scientific background helping us understand the complexities of cancer processes from

causality to prognosis and metastasis----explaining how cancer cells operate and how treatments are being

developed to target specific cancer triggers at the c

Significant findings reported: Moving beyond the one size fits all approach, Drs. Kinsella, Gray and Nevins

discussed how researchers have come to understand that cancer is not a single disease but rather a

heterogeneous spectrum of conditions that all vary by their biology and response to treatment. Understanding

the big science approach of molecular diversity, pathway signatures, DNA damage repair, and systems biology is

the driving force leading to the development of new combinations of treatments for cancer. In the systems

biology model, researchers are developing mathematical and computational models of cancer processes and are

testing them in a number of platforms. Using novel approaches, they hope to identify how DNA repair pathways

are linked to cancer causation and demonstrate the response of tumors and normal tissues to conventional and

investigational combinations of therapies. Dr. Kinsella laid the framework for the analysis of interactions among

components of a biologic system by pointing to the interactions of genes and genetics, complex signaling

networks, multiple cellular processes, micro and host environments. The goal, he states, is to integrate

approaches through multidisciplinary research teams which explore the multidimensionality of new databases as

well as quantitative and descriptive data. The challenge is in sorting out what is important---i.e., the crosstalk

between complex unstable signaling pathways and DNA damage repair responses. Understanding what is

important and how to how to apply the information to clinical trials, researchers are identifying molecular

features strongly associated with certain drugs and drug combinations in cell lines. They are hoping to test

patients in the clinical setting to match disease with molecular features. Based on the assumption that cell line

models can be useful for determining response to targeted therapies, Joe Gray discussed the use of 50 cell lines

to test approved and investigational drugs. He noted how mechanisms to exploit drug sensitivity and toxicity are

used in cell lines and emphasized that predictive markers tend to work well clinically. Many anti-cancer agents

show useful subtype applicability---i.e., K-13 kinase pathway targeted drugs show luminal subtype preferences;

anthracylines, platinum, and other mitotic approaches show basal subtype preferences; and lapatinib is

preferentially effective in ERBB2 amplified cell lines. However, although transcriptional markers offer a clinical

prediction of response, the question remains: can we predict clinical behavior by stratifying within ERBB2?. Of

note was the discussion of the way after optimization within EGF3001 and EGF10015 , CBX5, a conserved

nonhistone protein, emerges as a molecular prediction of response in ERBB2 tumors. Joe Nevins further

elucidated how the powers of genomics may be used to dissect biological complexity. This approach gives a

method for dissecting complexities by refining the ability of a predictor to measure sensitivity and find sub



signatures which predict response He underscored the take home message that a drug that works in 10% of

patients is not a failure but a reality. Our goal, he stated, is to get beyond HER2 in order to tease out the fraction

of patients that would benefit from a given therapy. The crucial issue is how to manage efficacy.

Messages I will take to my constituency: The power of genomics is that it allows us to dissect biological

complexities that define distinct genomic signatures which may be used in a practical way to predict prognosis,

drug sensitivity, biology, and ultimately pathway activation. Researchers set up a biological state in vitro as a

predictor of drug sensitivity. Teasing out some of the complexity of the relationship between pathway signature

and drug sensitivity signature addresses the real world of tumor differences and the way pathways operate.

Speakers concurred that we need combinations of drugs for subgroups. Researchers are adapting a systems

biology approach not just to do the right thing, but to identify combination therapies that would work by

matching the complexity of the disease to the complexities of different drugs. Combination therapy is key.

Personalized cancer treatment is critical not only to guide and drive the use of a single drug but to be the

cornerstone of how to put combinations together to identify who will respond, or who will resist any particular

agent. The ultimate goal is moving to combination therapy trials based on retrospective data and evaluating the

patient prospectively.


Explain:

Additional topics: Further understanding of systems biology approaches and methodologies....this concept

provides a big picture approach for understanding what makes cancer cells operate and how treatments targeted

to specific cancer triggers at the cellular level could be

Susan Samson Session Info: 6/1/2009 Molecular Imaging and Cancer Therapy: Focus on Clinical Trials

Special Session Hours credit: 1.25

Presenter1: Good Presenter 2: Good Presenter 3: Very good Presenter 4:

Comment: A fascinating important topic highlighting the complexities of developing and validating molecular

imaging techniques/diagnostics

Significant findings reported: Innovative imaging is an important element for personalizing medicine to evaluate

drug responses and to determine if a new agent is working. Functional imaging is key to the process. However,

there are many challenges associated with identifying appropriate biomarkers and tumor cells and developing

radio pharmaceuticals which will enable us to measure them. The development of these “non invasive biopsies”

is important in the path forward Although proliferation imaging using FLT and FMAU tracers is being explored to

measure therapy response, this type of imaging is not used widely….toxicity still is a key criteria for dose

selection. The challenges for using novel tracers in drug trials are numerous, including: assay availability,

methodological issues, timing of response, lack of reproducibility and data interpretation. Of note: FES uptake

predicts breast cancer response to hormonal therapy by providing a quantitative estimate. Estradial infusion will

reliably respond to endocrine therapy. AI administration causes early decline of FDG uptake and predicts

response The level of evidence for diagnostics is sketchy at present. For example, there is no evidence to suggest

improvement in outcome when breast MRI’s are used routinely for newly diagnosed patients. Moreover, there

often is a dramatic increase in potentially unwarranted mastectomies There is a need for multi center studies to

determine who obtains CR and who is benefiting from treatment versus those who should be stopped. Moreover,

regulatory and reimbursement is not well organized and greater rigor should be emphasized in these areas.



Messages I will take to my constituency: Molecular imaging provides a visualization and measurement of

biological process and multidimensional imaging. It has been used to image vascular dynamics and biological

determinants to detect and stage cancer, to select patients who will respond to therapy, and to monitor tumor

response. There are key questions that investigators must consider: How to choose the right patients? Does

the drug reach the target? Is there a response Will response lead to better survival? Although most tumor

markers are mixed, a diagnostic is clinically useful only if it is either prognostic or preductive, the magnitude of

effect is large..ie., greater chance for benefit, smaller toxicity risk, and the magnitude of effect is reliable…the

essay is reproducible. Technology is not science; a bad diagnostic is as harmful as a bad drug. The acceptance

of tumor markers is a question of values and involves a balance carrots and sticks. Rapid acceptance must be

balanced by validated clinical utility.


Explain: Upcoming Biomarker webinar will hopefully focus on many of these topics

Additional topics: The challenges of developing and validating molecular imaging biomarkersto specifically study

breast function and disease. Would like to know more about procedures for equipment evaluation, procedure

standardization, intersubject variance, choice of im

Susan Samson Session Info: 12:00:00 AM Magnetic Resonance Imaging for Breast Cancer: Impact on

Staging, Outcome, and Response to Neoadjuvant Chemotherapy Education Hours credit:

1.25

Presenter1: Very good Presenter 2: Good Presenter 3: Very good Presenter 4:

Comment:

Significant findings reported: MRI is sensitive for picking up in situ and invasive breast cancer only if quality

exams are performed. MRI's accuracy depends on how good the reference standard is. Although it is

characterized by the ability to pick up small nests of residual disease, it is difficult to see lesions less than 3 cm. If

doing poor quality work, then you get poor quality results. Problem: overestimation of response may occur.

Pathologically isolated nests of IDC of non contiguous disease---Although MRI not accurate if scattered cells

remain, radiation is effective in contracting microscopic disease in the breasts. Of note, breast cancer is a set of

diseases which respond differently to chemo. Different subtypes respond differently to tumor types present.

Guidelines needed: specifically, correct surgery post NAC still unclear. Moreover, no randomized trial of breast

MRI is ongoing to evaluate clinical outcomes as a primary endpoint.

Messages I will take to my constituency: Although MRI is the most accurate technique to evaluate response, pre-

op MRI does not significantly reduce those with positive margins. Moreover, although MRI is robust in predicting

non response of progression, no consistent evidence supports that the use of breast MRI improves clinical

outcome after breast conservation treatment. The problem with understimation of issues remains . Of note,

background enhancement is suppressed by hormonal therapy, radiation and ovarian suppression. However, a

strong signal enhancement after one cycle is a key predictive factor for disease free survival. Response is

evaluated by volume changes, kinetic changes and molecular changes. MRI leads to increased detection of occult

foci of disease, but it does not necessarily lead to improved tailored surgery. If a cancer is resistant to treatment,

then the MRI can predict if the chemo regimen is working. To use MRI routinely, you need some evidence of

benefit. Doing an MRI on everyone is irresponsible ...Risks of false positivity, incidental findings , delayed access



to treatment, and the increased use of mastectomy...some of which is inappropriate, can be challenging.

Future directions: CAD (computer based detection) can be promising---helps to better quantify residual disease


Explain:

Additional topics: The fole of breast MRI in preoperative evaluation remains controversial. Whether clinical

outcome is improved by changes in surgical management consequent to MRI detection of unsuspected lesions

remains unproven.

Susan Samson Hours credit: 10.50



Marion Schwartz Session Info: 12:00:00 AM Gastrointestinal (noncolorectal) 0 poster Hours credit: 1.00


Comment:

Significant findings reported: Confirmation of previous study, Phase III study

Messages I will take to my constituency: S-1 therapy more effective than 5-FU, or combo of irinotecan and

cisplatin, metastases still poor prognoses


Explain: large study, abstract well defined

Additional topics:

Marion Schwartz Session Info: 5/29/2009 Clinical Science Symposium plenary Hours credit: 0.50


Comment:

Significant findings reported: Best response in 5 - 9 off cohort

Messages I will take to my constituency: Complex research data for dosing schedule


Explain: Too complex

Additional topics:

Marion Schwartz Session Info: 5/29/2009 Clinical Science Symposium Hours credit: 1.50


Comment:

Significant findings reported: Single agent GSK089 not effective.

Messages I will take to my constituency: Continued research on daily dosing schedule. Mandatory pe-and on-

treatments biopsies to better define cMET pathway and target inhibition with GSK089


Explain: Too complex

Additional topics:





Comment: Safety evaluation

Significant findings reported: AMG 655 plus G well tolerated, phase II clinical trial is enrolling



Explain: Abstract well defined

Additional topics:



Comment:

Significant findings reported: IGFR directed agents. three deleterious alleles worse survival than with only one or

two

Messages I will take to my constituency: SNPs in the IGFR pathway genes may have prognostic value for LAPC

patients. Hopefully may identify patients who could benefit from IGFR-targeted agents.


Explain: Great comparisons

Additional topics: Gene identification

Marion Schwartz Session Info: 5/31/2009 Poster Session 4623 poster Hours credit: 1.00


Comment: Primary endpoint - response rate

Significant findings reported: gemcitabine, docetaxel, and capecitabine shows activity with a one year survival

rate

Messages I will take to my constituency: Watch of phase II trial to confirm by transcatheter arterial

chemoembolization benefits


Explain: Well documented poster

Additional topics:

Marion Schwartz Session Info: 5/31/2009 Poster Discussion 4532 poster Hours credit: 1.00


Comment:



Significant findings reported: Rash indicative to positive response

Messages I will take to my constituency: Further studies are under way to investigate - rash and efficacy with

erlotinib-based regimens


Explain: Clearly defines the differences supporting findings of previous phase III study

Additional topics:

Marion Schwartz Session Info: 5/31/2009 Poster Display poster discussion Hours credit: 0.50


Comment: unresectable HCC, primary endpoint evaluation of patients after 16 weeks of therapy

Significant findings reported: Appears to have significant activity with combination of bevacizumab and erlotinib

Messages I will take to my constituency: Phase II randomized trial is planned.


Explain: Comparisons were clearly defined

Additional topics:

Marion Schwartz Session Info: 5/31/2009 A RCT comparting BSC, FUFA, and GEm-Ox unresectable

gallbladder cancer 0 poster Hours credit: 1.00


Comment:

Significant findings reported: unresectable, FUFA, Gem-Ox increased survival. Both therapies tolerated, no

significant toxicity except liver function test in GEM-OX

Messages I will take to my constituency: Unresectable gall bladder cancer can achieve increased survival with

mentioned chemo


Explain: Explanatory Abstract

Additional topics:

Marion Schwartz Session Info: 5/31/2009 Disease-free survival as a surrogate endpoint for overall survival..

4517 poster Hours credit: 1.00


Comment:

Significant findings reported: 3 year DFS correlates to 5 year overall survival



Messages I will take to my constituency: 63% of data was evaluated: suggests that easier follow-up with

adjuvant therapy within 3 years. Most recurrence within 3 years - correlates to 5 year survival


on this topic)

Explain:

Additional topics:

Marion Schwartz Session Info: 6/1/2009 Gastrointestinal (Noncolorectal) Cancer Oral Abstract Session

Hours credit: 2.00


Comment:

Significant findings reported: radical surgery incl. lymphadenectory - positive, CS safer, Octreotide LAR favorable,

Gem -Cis v. Gem. for pancreatic adenocarcinoma - not beneficial to add Cis.

Messages I will take to my constituency: CS safer - higher OS (diffuse type histology) resection plus

lymphadenectomy still most positive, more studies needed but, Octreotide LAR proven benefit 5 months,

advanced CC improvement in mainly intrahepatic (although, not defined) minimal increase of toxicity,

gemcitabine vs. G cisplatin not shown to increase, OS, PFS. ORR


Explain:

Additional topics: Abstract 4503 neglected to differentiate between intra-extrahepatic groups, this study mainly

intrahepatic CC

Marion Schwartz Session Info: 6/29/2009 Dilemmas in the Management of Upper Gastrointestinal Cancers:

Focus on Symptom Management plenary Hours credit: 1.00


Comment: Meal Digestion, j-tubing, low fat meals, increased liquids, upright, Enzymes, Lipase 10,000 units,

erythromycin - intravenously, ascities: 15% cancer patients, SAAG testing clearer definition - diuretics working,

interperitonial catheters preferable to Pa

Significant findings reported: More attention is given to the discomfort of patients suffering from gastro. cancers.

A modified diet, upright position when eating, enzymes, and a possible jujenostomy should be explored. Ascities

prevalent in 15 % of all cancer patients, long term solutions for draining fluid, by-pass to consider

Messages I will take to my constituency: The care for gastrointestinal cancer patients can be improved with

above measures. Comfort can be provided with above measures, by-pass could be considered although, still

under investigation, Clinical Trial: Phase III Avastin/Oxyplatin - suggests that combo might be beneficial





Explain: plenary session / no material available

Additional topics: Kinase inhibitors

Marion Schwartz Session Info: 12:00:00 AM OXP plus PIFU and EBRT prior to surgery.... poster Hours credit: 1.00


Comment:

Significant findings reported: need for further trials - looks promising

Messages I will take to my constituency: Although, toxicity was observed - this study needs to be furthered.

Toxicity manageable, needs larger controlled group to further study


Explain: Clearly demonstrates in this group that further studies are indicated

Additional topics:

Marion Schwartz Session Info: 12:00:00 AM Analysis of survival with modified, docetaxel, cisplatin, mDCF,

and BEV in patients with metastatic GE adenocarcinoma Poster Hours credit: 1.00


Comment:

Significant findings reported: mDCFand BEV - increasing tolerable survival

Messages I will take to my constituency: 1/3 developed thromboembolism however 93% stayed asymptomatic -

arterial thrombosis not observed


Explain: Informative, broken down clearly into side-effects, demonstrating increased patient survival

Additional topics:

Marion Schwartz Session Info: 12:00:00 AM Chemoradiation of resected gastric cancer: 4515 poster Hours

credit: 1.00


Comment: Large 10year follow-up confirms that post-operative chemo does increase life expectancy

Significant findings reported: Diffused histology does not benefit

Messages I will take to my constituency: Women appear to have more of these cancer of diffused histology.




on this topic)

Explain:

Additional topics:

Marion Schwartz Session Info: Poster Discussion 4527 poster Hours credit: 1.00


Comment:

Significant findings reported: post-up CRT looks promising - needs larger trial to assess true benefits

Messages I will take to my constituency: Adjuvant gemcitabine-based chemoradiation after curative resection is

well tolerated. needs larger trial to truly assess benefit for PS


Explain: Well defined criteria

Additional topics:

Marion Schwartz Hours credit: 17.50



Millicent Sims Session Info: 5/29/2009 Fundamentals of Clinical Trial Design and Methodology 102



Comment:

Significant findings reported: Detailed description of the design and desired outcomes of Phase I & II trials given.

The rationale and results of randomized trials was discussed. Lecturer explained how statistical significance is

interpreted and where it comes into play of the study design. I have a better understanding of Power in statistical

terms now. The dual alliance of researchers to the study and to patients was discussed. And, ethical boundaries

dictated by IRBs was presented.

Messages I will take to my constituency: Several issues and problems must be considered when designing a trial.

Complexities and biases of trials can impact data, so results must be interpreted cautiously by scientists. Validity

of trial as well as efficacy of drug are high priorities for all researchers.


on this topic)

Explain:

Additional topics: Needed more knowledge of statistics.

Millicent Sims Session Info: 5/29/2009 Bone Health in Breast Cancer:Insights from Basic Science and

Clinical Research 158 Education Hours credit: 1.25


Comment:

Significant findings reported: BR CA treatment may cause increase risk of bone osteoporosis. Aromatase

Inhibitors may increase risk of fracture due to bone loss. Who should have Bone Mineral Density test? Females

<65 yrs old w/ risk factors.

Messages I will take to my constituency: Most effective drug for BR CA patients with osteoporosis is

Bisphosphonate which inhibits bone resorption.


on this topic)

Explain:

Additional topics: Would like to understand DXA (X-ray absorptometry) better.

Millicent Sims Session Info: 5/30/2009 Implementing Multi-disciplinary Clinics in Cancer Care


Presenter1: Very good Presenter 2: Very good Presenter 3: Good Presenter 4:

Comment:



Significant findings reported: Advantages; Coordinated consultations/treatments, more timely delivery of care,

improves clinical trial accrual, improved patient care. Disadvantages: less efficient for physicians, staff intensive,

need specialized equipment, need electronic medical records that may not be available.

Messages I will take to my constituency: Is a multidisciplinary clinic the right one for you?


on this topic)

Explain:

Additional topics: Is this the wave of the future for rural areas, higher income families, or increased competition

with cancer centers?

Millicent Sims Session Info: 5/30/2009 Bring GOD to the Bedside: Addressing the Diverse Spiritual and

Religious Experience of Patients with Cancer 102 Education Hours credit: 1.25

Presenter1: Excellent Presenter 2: Very good Presenter 3: Good Presenter 4:

Comment: Perspective of an OB/GYN Hindu practitioner not very helpful.

Significant findings reported: Importance of religious and spiritual beliefs of the patient and how to approach

these concerns.

Messages I will take to my constituency: Make patients aware of how their religious beliefs may be received by

clinician.


on this topic)

Explain:

Additional topics:

Millicent Sims Session Info: 5/30/2009 Crossing the 3% Barrier: Improving Accrual to Clinical Trials 159



Comment:

Significant findings reported: Community research barriers: access, trial complexity, randomization, side effects,

fear of placebo, cost, insurance, communication. Academic research barriers: cultural competency, CT not

available, docs method of communication, committing to infrastructure. Industry criteria discussed: site selection,

costs, trial design.

Messages I will take to my constituency: Poor communication skills of doc may impact whether patient goes on

trial or not.


Explain: Lecturers ability to explain topics indicated good communication skills.




Millicent Sims Session Info: 5/30/2009 Breast Cancer - Metastatic 34 Poster Hours credit: 0.50


Comment: Attended half of 1 hour session

Significant findings reported: Found HER-2 neg metastatic women benefit from Lapatinib + Letrozole. In

biomarker study, they found them to lower hormone receptor expression. Study of Paclitaxel + Bevacizumab

found older patients are at higher risk for toxicity, cardiovascular disease and hypertension.

Messages I will take to my constituency: Do research of previous studies on drugs if asked to participate in a

Clinical trials. Remember to tell oncologist about other pre-existing conditions.


Explain: Drug interaction was discussed in both pre-ASCO lectures.

Additional topics: Would be helpful to have a list of drugs and what they do.

Millicent Sims Session Info: 5/31/2009 Physical, Psychological, and Cognitive Challenges of Long-Term

Cancer Survivors 156 Education Hours credit: 1.25

Presenter1: Very good Presenter 2: Excellent Presenter 3: Excellent Presenter 4:

Comment:

Significant findings reported: Discussed Late Effects of treatment, toxicities, 46% of long term survivors will have

mental disorders in their lifetimes, depression during treatment the most common mental health issue, others

include anxiety, post traumatic stress disorder, sexual dysfunction, cognitive impairment.

Messages I will take to my constituency: Chemo Brain (Fog) is better understood. New research being done on

Neuropsychological performance. Cognitive tests are available for pre- and post-treatment evaluation.


on this topic)

Explain:


Millicent Sims Session Info: 6/1/2009 ASCO - American Cancer Society and Lecture Special Hours credit: 1.25


Comment: Awardee - Olufunmilayo Olopade, MBBS

Significant findings reported: >60% of people w/BRCA mutation do not have a family history of BRCA. Found that

the taller you are, especially when you first hit puberty, the higher your risk for BRCA. Also, there is a strong

association w/ER neg tumors and more aggressive disease. Birth control pills found to dec. Ovarian CA.



Messages I will take to my constituency: Genetic testing important for family health history of CA patients.


Explain: Genomics lecture helped me understand the importance of the human genome in personalized

medicine.


Millicent Sims Hours credit: 10.25



Sandra Spivey Session Info: 5/29/2009 Fundamentals of Clinical Trial Design and Methodology 267


Presenter1: Excellent Presenter 2: Excellent Presenter 3: Very good Presenter 4: Excellent

Comment: Thorough explanation of the process as well as honest critiques of where we are today in conducting

clinical trials.

Significant findings reported: Overall explanation of Clinical Trial design: Phase 0 is an optional Exploratory

phase recommended for 10-12 patients, as a set up for Phase I - good way to make sure our resources will be well

allocated for the next lines of study. Phase I - look at drug metabolism and side effects. There is some

controversy whether to start at a minimum dosage and accelerate - doing this could impact the built up tolerance

for patients and may mask results. Phase II - Design the Phase III study first before designing Phase II, that way

your Phase II is a stronger platform for building to the final stage. Need to look at molecular targets, if able to do

so, in Phase II and figure out an imaging strategy to assess effectiveness. Need to select the right imaging

process. Phase IV needs to be considered for all trials to follow patients to see if there are long lasting effects

not seen in the Phase III time period. Dr. Joffe discussed the issue of dual allegiance to the patient and to the

study. The purpose of the trail is to gather research information versus administer individual treatment.

Therapeutic Intent versus Scientific Intent is a struggle for the clinician with a patient participating in the trial.

Clinicians doing things outside the trial with the patient may actually be doing future harm as it can change the

results of the trail which impact many more patients in the future. End Points (goals) of Phase III trials should be

Overall Survival first. Response rate may not be a good end point as it may not matter. Someone could respond

to the drug but die just as early as a patient not on the drug. External validity tests need to be conducted to

remove investigator / sponsoring drug company bias. There is a significant number of Phase II trials that never

reach Phase III. In Dr. Alvin Feinstein's opinion, this wastes valuable time and research dollars. Much of this is to

legitimize current non-standard treatments or to build the CV of an investigator.

Messages I will take to my constituency: Thoroughly look at a clinical trial design before agreeing to participate.

Make sure it asks important questions that can make a difference to all patients. Make sure all your doctors

understand your role in the trial and what it intends to do so that if you need additional treatment for either

cancer or non-cancer conditions, your doctor can help assess with the investigator how that may impact your

participation in the trial.


Explain: The clinical trial discussion and materials built on my knowledge so that I could track with the

presentation.

Additional topics:

Sandra Spivey Session Info: 5/29/2009 Bone Health in Breast Cancer: Insights from Basic Science and

Clinical Research 158 Education Session Hours credit: 1.25


Comment: Superb graphic representation of how the osteoclasts and osteoblasts work in building bone and in

mineralizing bone.



Significant findings reported: Action from osteoclasts and osteoblasts need to be balanced in order to maintain

bone health. Cancer in the bone (metastatic or bone cancer) overstimulate either the "clasts" or the "blasts" to

create an imbalance. Even if the osteoblasts are overstimulated, the bone is still fragile because the

overstimulated osteoblasts create less than optimal bone structure. Osteoclasts have "ruffled edges" which

attach themselves to bone surfaces. These edges act as vacuums, pumping bone material from the bone into the

environment. It takes 3 weeks for one osteoclast to remove bone material that results in 3-4 months of work for

an osteoblast to rebuild the bone. There are significantly more bone fractures in patients on Aromatase

Inhibitors than on Tamoxifen. New bisphosphonates are under study - Arabon, Z-Fast, Sabre and Halt, which

may reduce risk of fractures for women on AI therapy. Denosumab is under study for bone mets. Dr. Bone

suggests 800 units of daily Vitamin D and 1,200 - 1,500 units of calcium for optimal bone health.

Messages I will take to my constituency: Bone health is important to both breast cancer survivors and all women

in the community. Those on AIs need to be monitored for fractures, particularly those on long courses of AIs.

Vitamin D may help make calcium more effective and help build back bone.


Explain: Cellular activity explained in the preread helped clarify the messages in this session.


Sandra Spivey Session Info: 5/30/2009 International Cancer Outcome Disparity: What Do We Owe Our

International Colleagues? 151 Educational Session Hours credit: 1.25


Comment: Extremely interesting and passionate discussions by all presenters. Too bad the session was so

sparsely attended by clinicians.

Significant findings reported: Dr. Boyle showed current trends that lead to the finding that tobacco, alcohol and

underweight account for most of the preventable cancers in the world. 55% of reported cancers are in

developing countries, with tobacco the main cause of a majority of the new cases. Increase tobacco usage lags

cancer rates as it takes time to develop cancer from onset of tobacco use, so additional cancers are expected due

to increased marketing of tobacco products in these countries. If the trends continued, over 1 billion of cancers in

this century will be due to tobacco use. Smokers lose 23 years of life expectancy versus non-smokers. In

developing countries, more deaths are due to cancer than the combination of aids, TB and malaria together.

Dr. Boyle's conclusions: 1) prevent cancers that can be prevented; 2) treat cancers that can be treated; 3) cure all

that can be cured; 4) palliate where needed. There are major deficiencies in access to all four of the above in

developing countries. Dr. Ribieiro is part of St. Jude where they have a Twinning Program that helps countries

develop pediatric oncology centers. Cure4Kids.com is an online service for international practitioners to educate

them on diseases and includes 1,100 on demand seminars. There is a feature for doctors around the world to

discuss cases and compare cases. Evidence suggests that most of cancer patient death in developing countries is

due to either non-treatment or abandoning treatment due to toxicity. St. Jude provides seed money to start local

community programs in developing countries and has found that this seed money starts local funding

mechanisms that sustain the programs once established. Dr. Rugo, an ethicist, discussed "moving beyond your

duty to patients" suggesting there are steps that all clinicians can take to promote health in their communities at

minimum and even take steps beyond to help externally. She compared the obligations of other professions,

clergy and legal, to those of physicians and brought up interesting gaps in how physicians carry out their



professional obligations to the community and to their crafts. She challenged tobacco-using clinicians to stop

smoking and to continuously prompt their patients to do the same and to take steps to do the same in their

communities.

Messages I will take to my constituency: There are basic things we don't do as patients / survivors to make sure

we get or maintain health in order to live longer. We often don't do those things and need to look at ourselves

instead of solely relying on our doctors to administer therapies. St. Judes has an excellent resource to educate

children on their cancers - Cure4Kids.com.


Explain: didn't apply to the subject

Additional topics:

Sandra Spivey Session Info: 5/30/2009 FDA and EMEA Initiatives: Meeting the Challenge of Oncology Drug

Regulation 117 Education Session Hours credit: 1.25

Presenter1: Excellent Presenter 2: Very good Presenter 3: Excellent Presenter 4: Excellent

Comment: Great interaction in the discussion that further clarified the topic.

Significant findings reported: The EMEA (European Medicines Agency that is part of the EU+2 additional

countries) acts differently than the US FDA in approving drugs. The EMEA is a networking organization versus one

agency and approves drugs for marketing. Individual countries then decide if they will approve the drugs in

question. EMEA is fee-related for drug companies seeking advice in navigating the approval system, although

this advice is optional. For a drug to be approved, it must have a positive benefit/risk ratio and must also have

post-release follow up data. EMEA has little or no involvement in clinical trial authorization, pricing,

reimbursement or compassionate use. A 60-100 page document is published by EMEA for all drugs submitted,

whether approved or not. FDA has a strict procedure for drugs under consideration. It starts with an

Investigation of New Drug application and includes end of Phase I and Phase II trial meetings. There is a special

early release protocol for drugs that are intended for use where there is no current treatment. FDA provides an

accelerated approval process which requires a Phase IV study to determine results after release to the public. If

the FDA rejects a drug, the rationale and ruling is considered non-public information. With the EMEA, it is public.

FDA requires "clinical benefit" of living longer or living better as the end point - EMEA uses a risk/benefit analysis.

Messages I will take to my constituency: Patients often ask why certain drugs are approved in Europe but not in

the US. Some seek treatment overseas. There is no easy answer to why there is a difference other than the

approval process is different, which includes additional agency oversight of trials in the US over the EU. Both

agencies are working to streamline their processes while minimizing risks to patients. One of the bigger issues

is follow up after drug approval. The FDA is considering more oversight there, for all drugs approved to make

sure that side effects as well as survival rates can be better tracked and reported to the public.


Explain: n/a

Additional topics: I wasn't aware the EU had a drug review group that did similar things as the FDA.

Sandra Spivey



Session Info: 5/31/2009 New Endpoints for New Treatments: A Time for Change in

Assessing Treatment Benefit 205 Education Session Hours credit: 1.25


Comment: Very thoughtful approach to the subject overall. Clearly communicated.

Significant findings reported: Dr. Booth discussed the bias of industry to spin results to sound more positive than

they might actually be. He mentioned that having negative or neutral results result in "financial toxicity" to the

sponsoring pharma organization. Dr. Booth advocated post-release follow-up for new drugs and conduct

population based outcome studies to truly assess the importance of the drug to survival. Dr. Averbuch discussed

Phase 2 trails and their purpose, reinforcing that the trial should be designed for safety, error reduction and cost

review - a "proof of concept." Dr. LoRusso revealed that 900 new drugs are due to be released within the next

10 years and that patient resources for clinical trials may be a problem. New trials will focus on molecular target

agents versus cytotoxic agents. It will be a challenge to determine proper dosing in Phase I tests given the new

substances under study.

Messages I will take to my constituency: Advocates should ask questions about new treatments to really

understand if the new regime might actually benefit the individual. They should expect their oncologists to

understand results of studies when recommending a new course of treatment. Patients need to ask their

doctors about clinical trials so that researchers can have a chance to have adequate participation to get

meaningful results.


Explain: The section on Clinical Trials helped clarify issues discussed.

Additional topics:

Sandra Spivey Session Info: 6/1/2009 The Expanding Role of Bisphosphonates and Novel Bone Agents in

Breast Cancer 393 Education Session Hours credit: 1.25


Comment: Clearly covered the subject matter. Provided several examples and showed how certain processes

work.

Significant findings reported: The largest issues for breast cancer patients with metastasis to the bone is "skeletal

related events" or SREs. Median survival with bone mets has doubled from 1997 to 2004, with median survival at

4 years. Current treatments seem to have reduced the spread of cancer from the bone to other organs, places

where a patient is more likely to die from the disease. Dr. Gralow explained that cancer does not kill or dissolve

bone cells by itself; cancer cells activate osteoclasts to dissolve bone and release nutrients into the environment

that the cancer uses to grow. This symbiotic relationship has been the target for several drugs, including the

current bisphosphonates and new drugs such as Rank Ligand inhibitors, Cathespsin K inhibitors and SRC kinase

inhibitors. There have been not trials that show overall survival improvement with the use of bisphosphonates

(or any advantage over the newer drug Zometa over Aredia); the results have focused on increased time between

skeletal related events. There are current studies reviewing dosage as well as a way to determine bone

resorption to inform treatment need. Dr. Coleman from the UK discussed the microenvironment "host factors"

that encourage breast cancer cells to target bone tissue. He also reviewed how Dox can allow more Zometa to

enter the cells for greater impact and AZURE test which will study anti-cancer activity in bisphosphonates. Dr.



Clemons argued that bisphosphonates have not maximized osteoclast inhibitions or else patients would not see

progression. He also reviewed how bisphosphonates don't lead to normal bone formation and make inferior

bone overall. Denosumab antibody (administered by subcutaneous injection) is a new drug that can work with

AIs for better overall results, including better bone health and greater quality of bone density. There is currently

a head-to-head study of Denosumab versus Zometa.

Messages I will take to my constituency: There are newer treatments under consideration for bone mets that

could result in better overall bone health. Trials are underway now and interested patients can ask their

oncologists about them. (REFORM, BISMARK, NCT00320710 and NCT00424983).


Explain: information about pathways helped clarify information covered in this session.

Additional topics:

Sandra Spivey Session Info: 6/1/2009 Cross Talk between the Estrogen Receptor and Other Targets:

Improving Endocrine Responsiveness 116 Education Session Hours credit: 1.25


Comment: Great presentations making a complex topic more understandable.

Significant findings reported: Dr. Johnson reviewed MTOR and how it might be used in combination with other

drugs to treat hormone resistant breast cancer. Dr. Santen reviewed the current hormonal treatments available

for breast cancer and why resistance takes place. He demonstrated how estrogen can use other pathways when

one is blocked, and that cancer cells can make maximize the use of the little amount of estrogen in the system to

help tumor growth. Dr. Forero discussed VEGF pathways and use of Avastin in a neo-adjuvant where patients

with stage II and III tumors were reclassified to stage 0 and I after using the drug before surgery.

Messages I will take to my constituency: In a metastatic setting, it's normal for a tumor to stop responding to an

anti-estrogen treatment due to the way the cancer cells figure out ways to get around the effects of the drug.

New studies are in process to figure out how to stop this from happening so that patients can benefit from one

type of AI or tamoxifen for a longer period of time.


Explain: Cell pathways discussed during conference calls.

Additional topics:

Sandra Spivey Session Info: Hours credit: 9.75



Roberta Stick Session Info: 5/29/2009 Fundamentals of Clinical Trial Design and Methodology 267


Presenter1: Barely understood Presenter 2: Good Presenter 3: Good Presenter 4: Way over my

head

Comment: Dr. Link talked way too fast Dr. Hilsenbeck tried to make statistics understandable by using the

concept of presumed innocent, guilty and reasonable doubt to explain null hypothesis, alternate hypothesis and

level of significance and even though I am a l

Significant findings reported: There was an explanation of the various types of clinical trials: phase 0 - exploratory

individual studies with no therapeutic or diagnostic intent; first in humans, limited duration, very limited drug

exposure and having the purpose of improving efficiency of subsequent trials, refining biomarkers and assays

using human tissues. Phase I trials identify dose limiting toxicity, identify maximum tolerated dose and asses

pharmocodynamic endpoints. It produces dose for Phase II. It starts with safe dose and identifies biologically

effective does which is more important than MTD since its purpose is to avoid toxicity and excessive cost. Phase II

- provides evidence of efficacy and the maximum chance of getting an accurate conclusion. There are frequent

stopping rules regarding inactive treatment. It is single arm and randomized and provides go/no go decisions for

phase III trials. Rationale for Randomized Trials - address effect of chance by adequate numbers and bias by

randomizing treatment assignments. It standardizes patient selection.

Messages I will take to my constituency: Since I review grant applications for NCI from the perspective of a

patient advocate, this information will give me more of a foundation regarding the various phases of clinical trials.


on this topic)

Explain:

Additional topics: I wish I understood statistics more.

Roberta Stick Session Info: 5/30/2009 Crossing the 3% Barrier: Improving Accrual and Access to Clinical

Trails 159 Education Session Hours credit: 1.25


Comment:

Significant findings reported: In pediatric oncology a majority of patients enroll in trials. Impact of low

enrollment: lost resources; research question becomes less important; drug development is terminated/delayed;

loss of skills; loss of innovation. If you do not have breadth, including rural recruitment, of patients, you will

legitimize the treatment. How to remove barriers in the community: improve access to trials; physician

engagement; financial (if you do more, you are more efficient); trials are complex Patient concerns: fear of

placebo, randomization/side effects; costs/insurance; distrust of FDA. There needs to be infrastructure

committed to clinical trials. Accrual rates at universities are .8 to 14%. 60% have no clinical trials offered - no

available clinical trials; physician's lack of interest, time commitment to other affairs, no institutional recognition

to enroll in clinical trials, salary tied to patients' seen and grant funding, clinical trial activity not linked to

promotion. Doctors are uncomfortable in discussing clinical trials; they need good communication skills and need

to have a research nurse. Doctors consider the ideal patient to be one who is compliant, easy to communication



with. Patients' reasons to refuse to participate in clinical trials: underrepresentation of elderly and m minority;

concerns of comorbidity; transportation problems; patients ability to understand. The elderly, however, are likely

to participate if offered. African Americans are less willing to participate due to lower income and are less likely

to be asked. Physicians impact accrual rates. Accrual is hindered because patients do not like randomized trials

and the drugs and their effects.

Messages I will take to my constituency: Patient advocates can improve understanding of clinical trials in their

constituencies!!! Working with physicians to encourage them to participate is key.


Explain: The ethical discussion was helpful.

Additional topics: Nothing

Roberta Stick Session Info: 5/30/2009 Bring God to the Beside: Addressing the Diverse Spiritual and

Religious Experience of Patients with Cancer 102 Education Session Hours credit: 1.25

Presenter1: Excellent Presenter 2: Excellent Presenter 3: Excellent Presenter 4: Barely understood

Comment: As to Presenter 4, it was extremely difficult to understand her because English is not her primary

language.

Significant findings reported: The exhortation to doctors was to engage in a dialogue not a monologue with their

patients; ask, listen, pay attention. Doctors need a skill set and knowledge regarding other cultures and beliefs

and the discipline to find information about what you do not know. The overarching goal is to negotiate a

solution that serves the patient and the treatment team. If religion and spirituality are coping mechanisms then

failure to address these are neglect. Learn what the patient has formulated to help him/her understand his/her

condition. The doctor should negotiate with the patient to create more options. Religious people would like to

be asked by their doctors about religion. Spirituality seems to have a protective effect on patient's health

experience and provides better coping skills. We search for meaning when we are diagnosed; by being spiritual

we are protected from hopelessness. The doctor should take a spiritual history of the patient: what is your

faith/belief how is it important in your life. How do you education doctors in these issues? Invite residents to be

part of this discussion. Model behavior. Be aware of boundary issues. open up but not too much.

Messages I will take to my constituency: The patients' expectations from their doctors is ever expanding. Their

spirituality and religious and cultural beliefs are valid and can/should be discussed with their doctors and in this

they are entitled to be respected. Doctors need advocates and patients to educate them on the importance of

religion and spirituality in patient care.


on this topic)

Explain:


Roberta Stick



Session Info: 5/31/2009 Plenary Session -Cancer Genomes and Their Implications for

Understanding and Managing Cancer; Abstract #1; Abstract #2 and Abstract #3. Plenary


Presenter1: Very good Presenter 2: Very good Presenter 3: Very good Presenter 4: Way over my head

Comment: I could not understand the discussion re PARP's at all. The presenter tried very hard to make this

comprehensible

Significant findings reported: In the discussion regarding cancer genomes, it was reported that all genes have

been sequenced and our task is now to interpret and exploit cancer genomes. Only a fraction of mutated genes

are drivers (increase net cell growth) while other mutations are neutral (they are passengers). Only 12 mutations

end up being drivers. We can focus on pathways rather than individual genes and thereby develop pathway

oriented therapeutics rather than the current emphasis on attacking individual genes. It is important to sequence

an individual cancer (immunotherapy) and determine the predisposition to get cancer. Regarding the benefit of

early treatment of relapsed ovarian cancer, there was no difference in survival depending on when the

chemotherapy was started. Women after first line chemotherapy can be given an informed choice - rapid access

to testing if there are symptoms of relapse. Years of chemotherapy can affect bone marrow. Monitoring CA125

is an integral part of ovarian cancer culture . Early identification of recurrence may facilitate complete surgical

resection extending survival rather than resort to second or third line chemotherapy. Follicular lymphoma

accounts for 25% of diagnoses; there is no curative therapy. Biovax ID is an idiotype antibody like that of the

tumor and is produced as a vaccine. Vaccination began 6-12 months after chemotherapy was completed.

Vaccine was found to improve disease free status. Ideotype vaccination demonstrates low toxicity. The

response to this presentation pointed out that these results received a qualified yes as to being positive. There

could be a role for vaccination. The study was a small study; 25% did not get a complete remission and 25% failed

to maintain a complete remission. The patients who participated in the trial had to wait 6 months, they were the

best of the best and had experienced a complete remission for 12 months. During the decade when these tests

regarding a vaccination were completed, rituximab has been a powerful addition to chemotherapy. There is a

role for vaccine after chemotherapy treatments but the vaccines need to be available to use quickly. Vaccination

in the management of follicular lymphoma is needed but with qualification. I was completely lost in the

discussion regarding PARP's and their inhibitors.

Messages I will take to my constituency: Patients should be made aware of the importance of cancer genomes in

individualizing cancer treatment. As an advocate for patients with lymphoma I would stress the importance of

supporting further research in the development of vaccines for treatment.


Explain: The pre=ASCO lectures and information regarding genomics was incredibly edifying in preparing me for

the initial discussion.

Additional topics: I am not certain as to what would have better prepared me to understand the PARP lecture. It

was just beyond my comprehension as a nonscientist.

Roberta Stick Session Info: 5/31/2009 Physical, Psychological, and Cognitive Challenges of Long-Term

Cancer Survivors Education Session Hours credit: 1.25




Comment:

Significant findings reported: By 2010 70% of cancer patients will survivor more than 5 years and the majority will

be 65 and older. Because of this information, greater consideration needs to be given to the long term effects of

cancer treatment. We need to develop better understanding of who is/is not at risk of toxicity from treatment

and better biomarkers to identify who is at risk. Psychological changes occur after cancer treatment. We need

to assess are long term survivors at increased risk of mental health problems; survivors have more distress than

the general population and cancer survivors have a high risk of suicide at 5 and 10 years after diagnosis.

Depression is common during treatment and is a long term risk even 4-8 years later. Survivors also experience

anxiety, PTSD, and sexual dysfunction. Distress affects quality of living, medical adherence, medical costs, and

health risk behaviors. Emotional needs are the #1 unmet need of cancer patients. The patient wants the doctor

to bring up this issue and the doctor wants the patient to bring it up. The doctor needs to ask, listen and repeat

and ask open ended questions. There is an effect on cognitive functioning from cancer treatment. Chemobrain

or chemofog does exist. 15-60% have neurophsychological impairment on formal testing after chemotherapy.

We need prospective longitudinal cognitive studies on the long term effects. Cognitive function has impact on

informed consent; it should be added to the potential symptom list of chemotherapy effects; there should be

more neuropsychological referrals. It is important that doctors tell patients of this impact of chemotherapy on

cognitive functioning and this is the physician's responsibility.

Messages I will take to my constituency: It is important that patients be apprised of the physical, psychological

and cognitive impact of cancer treatment. Much attention is given to the physical impact of treatment but

psychological and cognitive effects get short shrift and need to be stressed so that the patient is not blindsided

when these effects occur. Moreover, education will prepare the patient to deal with the psychological and

cognitive effects when they present themselves. The message should go out to the physicians that it is

incumbent on them to provide information about cognitive and psychological effects of chemotherapy as part of

informed consent.


Explain:

Additional topics: None were needed.

Roberta Stick Session Info: 5/31/2009 Compliance and Cost: Bitter Pills to Swallow in the Era of Oral

Cancer Treatment Education Session Hours credit: 1.25


Comment:

Significant findings reported: There is a growing presence of oral cancer drugs and it is important to identify

compliance with this therapy by viewing adherence in nononcology setting. There is better compliance in acute

rather than chronic disease; 40-50% adherence with chronic drugs; doctors are poor at identifying/predicting

nonadherence. There is not much information about adherence in oncology patients. They have too much to

lose; but most get their drugs by infusion. Nonadherence affects patients, providers and the health care system.

There is a practical side to the problem: cost, toxicity, polypharmacy, complicated schedule, forgetfulness and a

personal side: risk of not taking is high; reminds patient of the disease, comorbidity and need for support to take

the drugs. Nonadherence leads to false conclusions about therapy; if patients are participating in clinical trials

noncompliance may lead to underestimates; there is a waste of resources and increased health care costs.



Patients need to cope with the high cost of supportive medication. They do this by not filling prescriptions;

underdosing; getting public assistance or using doctor's samples. In studies of long term use of tamoxifen,

patients became tired; in prevention trials 20-46% of patients discontinue; there are better rates of adherence in

adjuvant treatment of cancer. Age was not associated with adherence. Psychosocial factors are the best

predictors of adherence. Various theories to explain poor adherence: operant conditioning - I take pill and

vomit cultural conditioning - God has decided my destiny control - you control something that may have a bad

outcome There was a presentation regarding a game Mission to encourage young people to comply to cancer

treatment.

Messages I will take to my constituency: As the number of oral cancer therapies increase, it is important to

encourage patients to comply with this treatment option. Educational tools should be developed to help patients

understand the importance of taking these drugs and what effect their noncompliance will have.


Explain: The slides used were helpful in organizing the presentation.

Additional topics: None. The information was straight forward.

Roberta Stick Session Info: 5/31/2009 Clinical Trials for Frail and/or Older Adults: Definitions, Design,

Recruitment and Outcomes 133 Education Session Hours credit: 1.25


Comment:

Significant findings reported: The key issue is understanding frailty which is more of a function of ability to

engage in activities of daily living than age. Those cancer patients with poorer functional status, i.e. more frailty,

have a greater risk of mortality and institutionalization. An increase in age will affect frailty w/frailty occurring in

36.6% of those 85+. Cancer is a perfect model for understanding frailty. A combination of clinical and biological

factors defines frailty in cancer patients. It is possible to design clinical trials for older cancer patients by

lowering the limit on age of accrual, upping the limit of participation based on functional status and including

those not eligible for standard treatment. There are ways to make participation in clinical trials easier for older

adults - use a multidisciplinary team, allow family and caregiver help as much as possible, minimize patient travel.

Messages I will take to my constituency: Older adults diagnosed with cancer should be encouraged to participate

in clinical trials and advocacy should be provided to ensure that the supportive services necessary for them to

participate are in place. Information that age does not in and of itself mean patient fragility; that other factors

such as ability to engage in activities of daily living are determining factors in participation in clinical trials and

that ultimately if frailty prevents aggressive treatment, patients should be offered light treatment and supportive

care.


Explain:

Additional topics: The presentation was straight forward and easy to understand.

Roberta Stick



Session Info: 6/1/2009 Access to Experimental Therapy Outside of Clinical Trials - When, if

Ever? Education Session Hours credit: 1.25


Comment:

Significant findings reported: There is conflict between patients who want immediate access to new therapies,

industry, the FDA that wants an orderly approval process and wants to avoid bad public relations with patients

and physicians who want rigor, scientific accuracy, ethical constraints, concern about getting access to new

therapies, and have a financial interest - are they going to be reimbursed for off label use of drugs. Individuals

want fairness in the selection process, an open protocol for orphan drugs and with expanded access to programs,

they need evidence of safety. For clinical trial advocates, there is an issue of reimbursement for routine patient

care by Medicare and private insurers. The concerns for early access are diverting focus and resources; uneven

playing field; incomplete data; promotion of unapproved products; by not doing good we may do harm. Patients

naturally reject randomized participation in trials. Some times there is little benefit and possible harm from new

treatments, e.g. bone marrow transplant for breast cancer. A modest proposal for enrollment: all standard

treatments are exhausted; patient not able to meet criteria of trial; all options exhausted. Companies should

work to inform patient advocate groups of beginning stage of drug development. For patients whose treatment

has failed, there should be aggressive care to relieve symptoms rather than pursuing untested therapies.-- This

view was espoused by one of the presenters and I vigorously disagree. The off protocol dilemma - a clinical trial is

needed to improve outcomes; if used off protocol there is slower accrual to the clinical trial, greater access to the

drug. Informed consent involves discussion of alternatives, including option of off protocol drug. I was not aware

of this and am concerned that many doctors do not do this. Is there a rationale for withholding off protocol drug

when it is offered in a clinical trial. Majority of doctors in academic practice provide OPRx. There is a conflict

between patient's interest and society's interest in research for the future. Autonomy v. beneficence. Who gets

to define reasonable options (therapy). Issues are difference regarding use of medical devices versus drugs.

Evidence of safety is essential.

Messages I will take to my constituency: It is important for patients to have information regarding current clinical

trials and drugs that are being used off label for treatment of their particular cancer. This information can be

provided by various umbrella agencies. Doctors' ethical obligations regarding informing patients of all that is

available both on and off label is information that should be discussed with both patients and doctors. It is

important to know that many doctors still do not understand that patients want to exhaust all options rather than

accept what is deemed by the physician to be an inevitable end.


Explain: The discussion on ethics was quite important

Additional topics: I think an expanded discussion of what constitutes informed consent is appropriate following

the information I gathered in some of the sessions I attended.

Roberta Stick Hours credit: 12.25



Tom Trotter Session Info: 5/30/2009 Melanoma Oral Abstract Hours credit: 2.50

Presenter1: Good Presenter 2: Very good Presenter 3: Barely understood Presenter 4: Very good

Comment: One presentation was laced with too many acronyms for my consumption

Significant findings reported: Mel remains an incredibly difficult disease with no trials showing significant

improvement in OS particularly with late stage disease.

Messages I will take to my constituency: Early treatment and deep patient involvement of disease management

continues to be important. No silver bullet yet...


Explain:

Additional topics: Really could have used a glossary of common terms and acronyms relating to Onc. I slowly but

surely am constructing my own, but help would be nice. Tks....

Tom Trotter Session Info: 5/30/2009 Research Review for PAs Education Hours credit: 1.25


Comment: All presenters were acutely aware they were not speaking to medical peers, so all were helpful in their

presentations. Loved getting reports on sessions I did not attend.

Significant findings reported: New staging coming for Lung Cancer. Possibly overtreating for prostate cancer in

men > 70

Messages I will take to my constituency: Interesting results, but nothing brand new, particularly for Melanoma or

cancer genetics.


Explain:

Additional topics:

Tom Trotter Session Info: 5/30/2009 Genetic Cancer Risk: Assessment w/i Comm Onc Practice


Presenter1: Good Presenter 2: Very good Presenter 3: Good Presenter 4:

Comment: Reasonably clear.

Significant findings reported: Some persuasive arguments were given as to why Oncs should be aware and

involved in genetic aspects of patient's disease. Challenges docs face in establishing a capability in tracking family

history.

Messages I will take to my constituency: Importance of a full and complete family history of even apparently

unrelated types of family cancer.




Explain:

Additional topics:

Tom Trotter Session Info: 5/30/2009 Genetic Testing and Society Education Hours credit: 1.25

Presenter1: Very good Presenter 2: Good Presenter 3: Good Presenter 4: Excellent

Comment: Would have been 90% lost without pre-training by Advocate Institute

Significant findings reported: Knew nothing about Lynch syndrome prior. Excellent background info. Direct to

consumer testing (internet etc) involves much hype and unsubstantiated claims. Genetic testing is in its infancy.

Messages I will take to my constituency: Be wary of use of genetic testing not recommended by physician. Great

inconsistency of some testing standards to the extent that identical samples sent to different agencies returned

conflicting results.


Explain:

Additional topics:

Tom Trotter Session Info: 5/31/2009 PA Research Review Session Educational Hours credit: 1.25


Comment: All were clear and articulate. They knew they were talking to Patient Advocates.

Significant findings reported: Although none of the reported sessions were of direct interest to me, I found Dr

Sandler's coverage of Prostate Cancer to be useful. The new requirement to micro-assay for testosterone was

new info.

Messages I will take to my constituency: Nothing significant.


Explain: Findings were not really tailored to genetics specifically. Interesting nonetheless

Additional topics:

Tom Trotter Session Info: 5/31/2009 Plenary Session Including Science of Onc Award & Lecture Plenary

Hours credit: 1.50

Presenter1: Very good Presenter 2: Very good Presenter 3: Good Presenter 4: Barely understood

Comment: There is no way I would have understood anything without the pre-course prep. Thank you!!



Significant findings reported: Intriguing metaphor for gene as a library of books. Helped take numbers and put

them in meaningful perspective. 99.9% of genes in cancer cells are identical to genes in normal cells. Search of a

cause / effect / marker is like a needle in a haystack.

Messages I will take to my constituency: Genetics field has a long, long way to go to make a difference at the

patient level in most diseases. Advances may be sooner than some think as answers fall into place. International

collaboration is important.


Explain:

Additional topics:

Tom Trotter Session Info: 5/31/2009 New Endpoints for New Treatments: A Time for Change in

Assessing Treatment Benefit Education Hours credit: 1.25

Presenter1: Excellent Presenter 2: Good Presenter 3: Very good Presenter 4: Very good

Comment: Pretty clear stuff....

Significant findings reported: Excellent overview of the evolution of trials. Using clinical benefit as an end point

may not be a real benefit to the patient. 65% of non final abstracts are changed by the time they go to final

results. Surrogate endpoints are problematic. Most valuable resource is patients.

Messages I will take to my constituency: Be extremely careful about making treatment decisions based on

incomplete trials and partially reported results. Phase 1 trials may have some efficacy for them.


Explain: These presentations were focused on Trial design and reporting. All of the pre-course training I received

focused on genomics, etc.

Additional topics: Basic tutoring on trial design and statistical significance would be helpful. I understood most of

the presentations because I have had grad level stats, but even that would have been helpful if dusted off a bit

before coming to ASCO.

Tom Trotter Session Info: 5/31/2009 Highlights of Day 1 including Clinical Trials Participation Awards

Oral Abstract Hours credit: 1.00


Comment: Interestingly these presenters were clearer in presenting their review of a presentation than the

original presenter.

Significant findings reported: Excellent summaries of some sessions I had been to and others that I had not.

Messages I will take to my constituency: Genetics field really is in its infancy. Do not count on significant

advances in v near term.


Explain:



Additional topics:

Tom Trotter Hours credit: 11.25



Jeanne Young Session Info: 5/29/2009 Advanced Concepts in Clinical Trial Design and Methodology 266

Extended Education Session / Clinical Trials Hours credit: 2.10

Presenter1: Excellent Presenter 2: Excellent Presenter 3: Very good Presenter 4: Excellent

Comment: Fascinating session, covered many important aspects about clinical trials, randomization and research.

Significant findings reported: In summary (Dr. Yu), blinded trials avoid bias. ITT analysis often increases risk of

false data. The quality of a trial is dependent on the compliance of the study subjects, it is essential. Equivalence

treatment is the effect between (-∆) and (∆). But, how do you choose the delta Safety, convenience, cost)?

Margin should be based on a combination of statistical reasoning, clinical judgment and the regulatory agencies.

In summary, the philosophies regarding early stopping vary according to individual ethics. Focus on study

subjects when the results are clear. Focus on the horizon, future patients or stop if study has the strength to

change clinical practice, with the latter being the conservative approach. Dr. Ratain: Randomized trials may

filter out inactive drugs, therefore all drug combinations that are not proven to be inactive may progress to Phase

II studies. Providing proof of concept, any combination may demonstrate sufficient evidence of activity progress

to Phase III. Phase II should determine whether a drug will be effective, that s the premise. Dr. Simon:

Randomized studies require larger sample sizes for Phase II studies. One exception is when time to progression is

short for the patient.

Messages I will take to my constituency: I found it interesting that no drugs have been approved based on

subgroup analyses. Most importantly, families/patients need to understand that the validity of trial results is

dependent on the compliance of patients. Randomized trials may filter out inactive drugs; therefore, all drug

combinations that are not proven to be inactive may progress to Phase II studies. Providing proof of concept, any

combination may demonstrate sufficient evidence of activity progress to Phase III. Phase II should determine

whether a drug will be effective, that s the premise. Randomization was also considered important to research,

however, it is vital that patients are fully understanding about what it means to be randomized. Just a comment:

It was also interesting to hear it said that researchers highlight the information they want you to hear, the

positives; although this was not really surprising. The speaker, Dr. Ellenberg, also indicated that release of early

information is often contradictory to the actual end results. When attending conferences I have wondered if the

preliminary results actually match the end results. This is something I would share with my Board Members.

Knowledge interim data can influence trial conduct, affecting patient entry, patient assessment and sponsor

action.


Explain: The first Webinar covered some of the information in a basic sense to enhance understanding.

Additional topics: The concepts were clear and easy to understand. However, I do question if some further

consideration will be given to releasing preliminary data when it may in fact be inaccurate. In addition, comments

were made that this practice, although educational,

Jeanne Young Session Info: 5/30/2009 Research Review Session for Patient Advocates Patient Advocacy

session, mentor Hours credit: 1.25


Comment: Kelly Cooke, M.D.; Julie Gralow, M.D.; and Jennifer Obel, M.D.



Significant findings reported: Kelly Cooke, DO, general medical oncology at the Central Texas Veterans Health

Care System. Males who carry BRAC 1 or 2 are not expected to be seen often and may not be screened. Breast

cancer is often looked as a female disease. Families need to stay in touch with their genetic counselors. In the

past, clinicians and researchers were not aware of the link between breast and prostate cancer. One third of men

over 70 are often over-treated for prostate cancer. It is not always necessary to treat older patients. There is a

difference in approach for a patient diagnosed at age 50 versus age 70. Men who have aggressive prostate

cancer die in about 4 years. In regard to lung and prostate cancer, focus is on gene amplification, targeting genes

and new drugs. Julie R. Gralow, M.D., Associate Professor of Medical Oncology at the University of Washington

School of Medicine, and the Fred Hutchison Cancer Research Center. Aromatase inhibitors impact bones and

takes away estrogen. Stem cells are not ready for prime time. There are disseminated cells, so how many stems

cells are out there? She referenced a slide shown during the stem cell session, a picture of a BRACA gene with

two points on it. One point dropped out after they did something and then became triple negative breast cancer.

There are some anti-angiogenesis drugs in the pipeline Jennifer Obel, M.D., Attending at North Shore University

Health System. Rectal cancer is found in the lower part of the pelvis. Chemotherapy and radiation approaches

are used. It is hard to go straight to surgery for rectal cancer as opposed to colon cancer. Anal squamous cell

cancer is sensitive to radiation and may be cured with RT/Chemo. However, one compound, mitamyacin has

been replaced by cisplatin. Cisplatin is less toxic; however, survival outcomes did not change. 90% of patients

with metastatic colon cancers do not suffer consequences from not removing the primary tumor and do well with

only undergoing chemotherapy. Q&A: It is important to look at the trend of PSA results, but it must be watched

for how fast they change. There was a session about Vitamin D studies that indicated it is a cancer prevention

approach. Although the session was good and Vitamin D is interesting it has fallen off the radar. Higher grade

breast cancer patients have shown low calcium, Vitamins B and D.

Messages I will take to my constituency: 90% of patients with metastatic colon cancers do not suffer

consequences from not removing the primary tumor and do well with only undergoing chemotherapy.


Explain:

Additional topics: A comment was made by Dr. Gralow about a slide that had been presented in one of the

sessions, I am not clear on what was done to cause on point of the BRAC gene to drop off, thus creating TNBC. It

might have been helpful for the audience to have a print

Jeanne Young Session Info: 5/30/2009 Low Grade Gliomas and Anaplastic Oligodendrogliomas

Education Session: CNS, nursing and pharmacy Hours credit: 1.25


Comment: Excellent session, the neurocognitive effects of radiation is an area that is always of concern to

patients with brain tumors. Low grades and other very rare tumors that have not had as much research attention

are of interest, but there is very little ne

Significant findings reported: Management of Low Grade Gliomas: Low grade glioma patients are generally

offered three options: simple follow-up, biopsy, and resection. There is often a fear of the watch and wait

approach because of the risk of missing non-enhancing tumor. It is possible for low grade gliomas to undergo a

malignant transformation and up to one year before this happens there are predictors. Low grade glioma

genotyping should be part of the diagnostic process. Radiotherapy has been poorly studied; response to RT is



30-60%. Increasing RT dose does not add to survival, but instead causes more toxicity. RT can cause induced

encephalopathy. Patients are afraid of radiation. Chemotherapy is the primary therapy in low grade tumor,

however, little has changed over the years the drugs include carboplatin and vincristine. In the past few years

temozolomide has been added to the drug arsenal. Low grade gliomas are a heterogeneous group with chronic

disease. Management of low grade gliomas is a lifelong process; many patients live for 20 years or more. There

have been some significant technological surgical advances, although they are more expensive they are safer to

perform. Management of Oligodendroglioma: Anaplastic oligodendroglioma (AO) comprises <5% of glioma and

is a rare tumor. Management of these tumors varies widely. Diagnosis of AO is difficult and may contribute the

low incidence percentage. They do have specific MRI features. Survival s ~5, but varies. Surgery provides larger

resection and possibly better patient survival. Radiation is effective in malignant glioma. TMZ is active in this

tumor type, AO, but may not be as effective as PCV. The side effects of PCV can be toxic and patients can develop

myelosuppression, anorexia, and rash. Phase II trial summary: No overall survival benefit from PCV and RT

versus RT (early). Neurocognitive effects of Radiation Therapy: Cognitive function is vital and deficits can be

devastating. Radiation can be harmful and beneficial. Benefits include tumor reduction and improved

neurological function, epilepsy, and extended survival. On the other hand, there are risks of toxicity to the central

nervous system. Factors associated with toxicity and dysfunction can include the amount of total dose, duration

of therapy and the volume treated. There are host factors, such as age, genetics, tumor type, CNS disease and

systemic disease. Other considerations for neurocognitive issues include surgery, chemotherapy, and

combination treatments. Prominent neurocognitive dysfunctions can include the following neurological issues;

motion, speech, and epileptic seizures and ICP. Patients can develop delayed radiation encephalitis three month

to 10 years following radiation.

Messages I will take to my constituency: Some of the information covered is shared with our constituency.

However, I would share that low grade glioma genotyping should be part of the diagnostic process. In addition, I

would also include, “There have been some significant technological surgical advances, although, they are more

expensive they are safer to perform.”


on this topic)

Explain:

Additional topics: It would be interesting to know more about genotyping. Although the session was informative,

there really is not much new information about the low grade gliomas or other more rare childhood brain tumors.

As an aside, I did not see/hear anything related

Jeanne Young Session Info: 5/30/2009 Genetic Testing and Society 0 Ethics, Cancer Genetics; Education Hours

credit: 1.25


Comment:

Significant findings reported: Genetic testing continues to develop with greater accuracy. The expense for

testing is high. It is important for patients and families to have appropriate counseling. Informed consent for

genetic testing will require some additional considerations.

Messages I will take to my constituency: Genetic testing has developed for sickle cell anemia, colon, endometrial,

and ovarian cancers, as stated in this discussion. Other genetic tests also exist, though not specified in this talk.



Although there are some concerns regarding testing, the benefits may help to personalize medicine. Laboratory

quality in testing is important in respect to accuracy and patient confidentiality. There are concerns about

independent testing that is offered through 27 Web Sites, they often do not provide necessary counseling or

clinicians for comment. Patients and families would be advised to go through proper channels to obtain their

testing and to consider their options.


Explain: The Chapter information in The Hastings Center; Bioethics, Briefing, and Campaigns was insightful and

the companion session was helpful and an excellent refresher with some new information.

Additional topics: In summary, does a special informed consent need to be developed to protect patient privacy

that includes the inherent risks of genetic tests? Dr. Bradbury concluded that yes, informed consent should be

developed specifically for genetic testing, especia

Jeanne Young Session Info: 5/31/2009 Plenary Session including Science of Oncology Award and Lecture


Presenter1: Very good Presenter 2: Excellent Presenter 3: Excellent Presenter 4: Very good

Comment: Comment: Merrill Egorin, M.D. and J. OShaughnessy, M.D. (Abstract 3); N. Wolmark, M.D. and Lee

Ellis, M.D. (#LBA4)

Significant findings reported: Triple negative breast cancer (TNBC) BRAC-Different Cells are sensitive to PARP

Standard treatment is limited, median progression free survival (MPFS) is 3 months; PFS less than or equal to 4

months with chemotherapy for metastatic disease. Bevacizimab/paclitaxel improves progression free survival

(PFS) compared to PFS alone. PARP with platinum is of interest for this disease. Phase II of gemcitabine and

carboplatin, evaluated the clinical benefit rate = stability; Inclusions were: measurable disease, stable brain

metastases allowed, patient’s randomized to gemcitabine/carboplatin, and BSI 201 at disease progression. Final

analysis will take place in the fourth quarter of 2009. Median age is 52-55; PARP 1 gene expression was

significantly upregulated compared to study controls and MPFS was 3.3 to 6.9 months with gemcitabine and

carbo. MOS was 5.7 to 9.2 months with gemcitabine/carboplatin, and BSI 201. 40% of patients who were

randomized to gemcitabine/carboplatin have crossed over due to progression. PARP 1 gene expression was

significantly upregulated compared to controls and upregulated in most evaluable TNBC patients. Dr.

O’Shaughnessy presented information about BSI-201, a promising drug that is effective for TPBC. TPNC has not

been responsive to standard approaches. BSI-201 so far has shown to extend life for up to three months. The

combination of chemotherapy and PARP has extended life in breast cancer patients, but a cure has not yet been

found. The goal is personalized medicine. Standard treatments for TPNC are limited with medium progression

free survival of 3 months. PFS is less and or greater to 4 months with chemotherapy for metastatic disease. The

Phase II gemcitabine and carboplatin trial evaluated the clinical benefit rate and stability for the combination.

Participants included had measureable disease and were randomized to gemcitabine/carbo and BSI201 at disease

progression. Patients with stable bran metastases were included. Median age for patients was 52-55. PARP1

gene expression was significant and up-regulated compared to controls. Median progression free survival was

3/3 to 6.9 months for participants who received gemcitabine and carbo. Statistics for those who received

gemcitabine/carbo and BSI201 was 5.7 to 9.2 months. 40% of randomized patients who were taking

gemcitabine/carbo have crossed over to the other arm due to progression. Issues associated with the trial

included, anemia, thrombocytopenia (Grade 3-4), neutropenia, and febrile issues. Grade 3 toxicities were



uncommon and there were no grade 4 incidences in the two arms. PARP 1 was up-regulated in most evaluable

TNBC patients. BSI201 with gemcitabine/carbo was well tolerated and did not potentiate chemotherapy.

www.BiParScience.com Dr. Norman Wolmark, A Phase III Trial Comparing mFolFox6 to FolFox6 plus bevacizumab

in Stage II or Stage III Carcinoma in Colon: Results of NSABP Protocol C-08, Abstract #LBA4 58.3 mostly male

participants, Stage II (0) 24.9 and Stage III 45.4 Toxicities associated with bevacizumab include, hypertension,

pain, proteinuria, and wound complications. Riche’s Avastin fails in study. He stated that we failed not Roche

and questioned if there was a significant transient effect of bevacizumab. Dr. Wolmark joking stated that 000

after a decimal gives statisticians an endorphin rush. The final analysis indicated that although there was a

difference it was not significant. Are there rebound effects or it is the effect with bevacizumab? The AVAT

B017920 –similar trial included 3,450 randomized patients. It is anticipated this trial may confirm the transient

effectiveness of bevaciumab. Lee Ellis, M.D. follow-up with his perspective about the FolFox trial. What if

Norman is correct about the negative clinical trial not increasing 3 year disease free versus FolFox alone. More

than 2,500 patients participated in the trial. He indicated that there was an early benefit in the

FolFox/bevacizumab arm. Ultimately, bevacizumab does not lead to a paradoxal increase in disease. In addition,

Dr. Ellis remarked that there is some benefit to adding bevacizumab to FolFox but is dependent on; tumor

microenvironment and vacularity of microscopic tumor are distinct from macroscopic tumors. There is an

angiogenic switch in hepatic tumors. There is nothing to validate, thus far, to indicate that bevacizumab could be

antiangiogenic.

Messages I will take to my constituency: BSI-201 is a promising drug that is effective for TNBC. Studies are

ongoing to further research efforts in TNBC.


Explain:

Additional topics: Final comment on the opposting presentations about negative clinical trial not increasing 3

year disease free versus FolFox alone would be interesting. I would like to have a stronger knowledge base about

TNBC.

Jeanne Young Session Info: 5/31/2009 Risk Factors for Brain Tumors Education Sessions, CNS; Cancer

Prevention/Epidemiology Hours credit: 1.25


Comment: Elizabeth Brooks Claus, M.D., Ph.D; Faith Davis, Ph.D.; and Siegal Sadetzki, M.D., MPH

Significant findings reported: Report overview of the statistics from the CBTRUS was highlighted during the

session. Tumors that have been considered benign have been counted for years now. Males are more frequently

diagnosed with brain tumors, with the exception of women having a higher incidence of meningioma. 1% of

diagnoses are made in random trauma centers. Meningioma patients generally do well, however, if they are high

grade they tend to be aggressive. A study finding indicated that hormone replacement is a factor in meningioma

diagnosis, but there was no evidence that contraceptive us is a concern. Women who have been diagnosed with

meningioma are encouraged not to take hormone replacement. To date, there are no data on fertility

medications. Low grade glioma (LLG) differs according to subtype. A subgroup of 25% of patients lives for several

decades. Oligodendroglioma patients often have a 20 year survival rate. The risks for gliomas in adults include;

high dose radiotherapy, heredity, syndromes, male gender, White ethnicity, and a history of seizures. There are

also negative association for gliomas with asthma and eczema. Faith Davis, M.D., discussed ionizing radiation



and potential development of brain tumors. Benign head and neck tumors in children after RT/Gy of 1.1 may be

associated with acoustic neuromas and 4.6 Gy for cerebellar pontine gliomas. Younger people are more

susceptible than adults to brain tumors after radiation exposure. Risks also differ according to disease site (organ

or tissue) and some cancers have not convincingly shown to increase after RT exposure. The risks are associated

with the dose. Epidemiology indicates that no genetics or heritable conditions have been found to be associated

with RT and brain tumors. Tinea Capitis cohorts suggest some susceptibility, increasing risk of development of

meningioma after exposure to radiation (2007- Flint-Richter). Females are more susceptible than males from

risks of brain tumors after radiation exposure. In conclusion, she indicated that Ionizing RT is an independent risk

factor associated with brain tumors. Siegel Sadetzki, M.D., MPH, discussed cell phones and brain tumors. Energy

is powerful enough to break chemical bonds that might be interactive with tumor promoters for cellular users.

However, overall evidence does not indicate that radiofrequency waves influence tendencies for brain tumors.

Ionizing RT is a risk factor. Laterality of exposure with cell phone use is localized, involving exposure to the lobe

on the side o f the head where the phone is held. Temporal lobe tumors would be considered for such studies. If

an individual is concerned they should consider: keeping calls short; use of speaker or hands-free-device or

earphones; hold phone away from the body; or text message instead of making calls. In France, they do not allow

the purchase of cell phones for children before the age of 12. Some believe age 16 or 18 to be more appropriate.

In summary, exposure to cell phone use is huge; most radiation exposure to the brain is in the temporal lobe; and

evidence about cumulative exposure is insufficient at this time, and risks may be greater for people who have 10

or more years of ipsilateral exposure.

Messages I will take to my constituency: Conclusion: Genes that repair DNA when injured my play a role in

meningioma and glioma risk. Gliogene has an international collaborative effort to find families with two or more

individuals with a brain tumor, www.gliogene.org. However, I would first want to learn a bit more about Gliogene

to ensure that they provide genetic counseling. I would also share some of the risks, previously mentioned.


on this topic)

Explain:

Additional topics: The verdict on cell phone use seems to remain in question by the brain tumor community. It is

good cautionary advice has been given. I look forward to learning more. The session was straightforward.

Jeanne Young Session Info: 6/1/2009 Electronic Health Records Choices in Large Groups and

Institutions—Where is Oncology’s Voice? 0 Education Session—Practice and Management, Info

Tech Hours credit: 1.25


Comment: The speakers were very clear and understandable. It is a topic of interest and from my understanding

from physicians that are using EHR, many find it ridiculously expensive and not ready for prime time. The

physicians I am speaking of are not oncologists

Significant findings reported: Very interesting session, complex system with patient safety concerns. Peter Paul

Yu, M.D. Larger vendors do not focus on oncology Small Specialty Vendors: • Understand perspective of

different HER system users • Can facilitate patient care, aiding in finding information more quickly; general

information, nature or care and nature of cancer The value EHR system for patients: health care delivery system;

helps academic community access information; supports the underlying healthcare system; stores a variety of



databases; and importantly for patients to know access to patient information and data are restricted There are

some EHR system issues that need to be resolved, such as, the difference in diagnostic situation: MRI for a

focused area of oncology or something more multi-dimensional EHR supports end users, physicians, mid-levels,

nurses, and allied health care professionals. Philip Strong, M.D., Internist, Palo Alto There are the obstacles of

bureaucracy, governance and operation to resolve. He commented that where some people see chaos others see

opportunities. Major systems include: EHR, IDX, Dictaphone and Philips What is Electronic Heath Records? The

major aspects include: clinical documentation, tests, imaging results, and support. Basic EHR with and without

clinical notes: --Doctors may lack access to advanced directive --EHR provides results and reports, but not images

(MRI CT, etc.) --no clinical decision support It is a complex problem because EHR is capital intensive, labor

intensive and there are major issues involved Admittedly, Dr. Strong said there may be some patient safety issues

and mechanisms need to be in place. (This is a situation of concern for patients). The EHR system is having

additional issued due to the economy. Dr. Linda Jacobs, Abramson Cancer Center EHR has been a work in

progress for over 16 years. They have been assessing a definition for EHR, need, implementation plan; developing

standards, systems, and technology. It has rapidly become a requirement that they look at patient safety issues,

HIPPA, standard of care, and issues regarding documentation. Documentation issues include; efficiency,

consistency, and barriers. EHR is costly to maintain. It is being pushed as a requirement with a goal of improving

the quality of care and better coordination amongst providers. Other areas for improvement are the

development of chemo ordering and administration; two critical pieces include plan and flow charts.

Chemotherapy and administration took separate systems to interface; paper to cyberspace, mandatory staff

training. There are some areas that are complex in oncology that need to be addressed. Paper charts to ERM:

chart preparation for patients to be seen; key documents need to be scanned; and MD/PhD’s notes.

Messages I will take to my constituency: The EHR system is still a work in progress. Although the goal is to make

patient information more readily available in a secure manner within the medical system, they are still perfecting

the system and safety or patient information.

Did the course materials help you understand this session? NoN/A to this session (pre-ASCO materials not


Explain:

Additional topics: It was not that I didn’t understand what the speakers were saying. I am interested in knowing

how safety and privacy issues will be resolved. Patients and families want to feel there health records are private,

secure and not so easily shared. I would

Jeanne Young Session Info: 6/1/2009 Radiation Therapy Update: Role, Route, and Rationale for Protons

and Electrons 0 Education: Pediatric Cancer Hours credit: 1.25

Presenter1: N/A Presenter 2: Excellent Presenter 3: Excellent Presenter 4: N/A

Comment: Nancy Tarbell, M.D., radiation oncologist, from Harvard Medical Center opened the session,

introduced the two speakers and described the lecture topic’s contents briefly. At session end, she facilitated the

brief question and answer session. Areas cover

Significant findings reported: Wolden: There has been progress and some successes in the treatment of

Hodgkin’s lymphoma, neuroblastoma, sarcoma, and medulloblastoma. Since the 1960’s cure rates have tripled in

pediatric cure rates with RT. Medulloblastoma is common in the posterior fossa, 60-85% survive depending on

tumor stage. External radiation moved to 2 dimensional lineac to 3 D RT. Other types of radiation that have



evolved include, stereotactic, Intensity Modulated Radiation Therapy (IMRT), protons, electrons, other particle

beams, image guided RT, and IGRT. Brachytherapy is another form of RT that uses seeds percutaneously through

the tumor bed. This type of radiation is a good choice for patients who have cancer of the tongue; brachytherapy

can treat the tongue without going through bones. Cures for RT in Hodgkins developed in the 1970s. PET scans

have proven to be an excellent scanning method for Hodgkin’s lymphoma. When chemotherapy was added to

treatment the RT fields shrunk. IMRT and protons have not shown any obvious benefit of anterior/posterior

fields. Twenty four years ago neurofibromatosis delivered a fatal prognosis; now there is a 50% cure for high risk.

In cases with skull metastes, the brain can be blocked and successful delivery of RT can be given to the skull

sparing the brain, leaving it unaffected. Rhabdomyoscarcoma is radiosensitive. The majority of patients in the

US receive RT. Survival rates have increased for these patients since the 1960s while the intensity of treatment

has decreased. The goal is to decrease the dose of radiation. IMRT reduces margins; it is conformal and offers a

lower dose especially for eyes. Another feature of IMRT is dose painting, providing different dose to each area,

each day; possibly total dose to one area and low dose to another, i.e., 50% gy and then 15 gy to another area. In

summary, Dr. Wolden feels RT plays a pivotal role in pediatric cancers because it can decrease long term side

effects. In addition, she reminded us that some older techniques are still preferred depending on tumor location,

type and age. Dr. Torunn Yock (www.protonsforkids.org) Regular radiation is high energy photons in the

electromagnetic spectrum. They are low energy x-rays for diagnosis purposes. Radiation causes double strand

breaks in DNA. Normal cells repair DNA damage. Most curative treatment takes 5-8 weeks. Morbidity includes

lack of or abnormal tissue repair; younger age and uses multiple proton beams. 3-D conformal or IMRT spares

areas such as the spinal cord and dose can be decreased. Multileaf Collimater, also known as LINAC has chunks

of metal that are used to modify dose. The remainder of her topic focused more on photons versus protons.

Protons are particles with charge and mass, the sources are H2O or H2 gases and are energized in a cyclotron.

The depth of the penetration is determined by the energy. Protons deposit does in tissues causing an ionizing

event in cells that lead to DNA strand breaks. The biological effectiveness is superior to photons. Advanced

protons provides better dose localization in tumor, thus leading to less late toxicities, reduced second

malignancies, and is superior to external beam RT. Protons are effective for many, but not all pediatric cases

(brain tumors and sarcomas).

Messages I will take to my constituency: The most important message for my constituency is for parents to

understand that the medical community understands the need to decrease the amount of radiation whenever

possible and to reduce margins. It is also important, when dealing with brain tumors, for families to understand

that radiation may cause some cognitive impairment, but other factors may also play a role. IMRT has provided

dramatic advancements in RT, as has Proton beam RT. Protons are the most conformal of all radiation

technologies offered today. There are 5 proton beam facilities in the US. Pediatric low grade gliomas may be

able to have proton radiation. On case was shown as an example, the patient did not suffer loss of IQ. Five other

measures are under study. The type or radiation offered for treatment is variable, it is dependent on location,

disease type, and size.


on this topic)

Explain: The topic was specific to radiation options and the differences.

Additional topics: I have always found it fascinating to learn about the advances in technology. Radiation options

are significantly different from what was available (or not) decades ago. It amazes me to remember back to the

early '70s to know how much progress, although



Jeanne Young Session Info: 5/29/2009 New Response Assessment in Neuro-oncology 164 Education

session, CNS Hours credit: 1.25


Comment: Martin Van Den Bent, MD., Ph.D.; Susan Marina Chang, M.D.; Gregory Sorenson, M.D.

Significant findings reported: Martin Van Den Bent, M.D, Ph.D.: Response assessment in newly diagnosed GBM

and pseudo-progression Patient asymptomatic—you can watch and wait, follow patient and may find decrease

on the next scan, if so, it was pseudo progression. Trial—all patients (high grade glioma) treated with radiation

therapy in two randomized trials. Pts. followed pre-RT, post-RT, and every 3 months and neuro exam, 9 of 32 had

pseudo progression Basically, uses area of enhancement as primary tumor measure—changes in contrast

enhancement area considered as changes in tumor. Enhancement can imply leaky blood vessels, indicating blood

bran barrier disruption. Enhancement does not equal tumor, but reflects high grade tumor activity. Early

delayed CNS toxicities after combined chemo/RTL 18 of 85 had pseudo-progression (21% of patients). Early

progression after RT/TMZ: after RT pts had increased edema Pseudo-progression, clinical signs and symptoms:

neurological deterioration is present in 33-34% of cases with pseudo-progression. Does not distinguish between

PsPD and valid PD. An average of 7 months is needed from clinical resolution. Pseudo-progression after RT: on

immediate post RT, MRI scan increases mass effect; the individual or enhancement? Spontaneous improvement

with or without treatment? Histology—hyaline vessel changes, edema with RT necrosis Inflammatory reaction—

early or delayed reaction to RT, edema, abnormal permeability, VEGF, mediated? Gradual transition to RT

necrosis? Susan Chang, M.D.: Surrogate Imaging Markers of Response Response assessment is critical for brain

tumor patients. Patients want accurate, reproducible, valid, meaningful information. Radiologist response—

traditional; variable differences; diameter (linear), area is bi-dimensional or volume (three dimensional). Effect of

Diameter, Area , or Volume of Measurements—all important and different measurement criteria. Measure

enhancing component only Grade Grade 2 is normally not enhancing. How do you assess volume or a tumor

with a large necrotic center? Challenges in assessing response in recurrent malignant glioma Discordant

improvement of enhancement, but development of progressive abnormal FLAIR. Patient can decrease with this

change. Criteria to determine progression: Within first 12 weeks after completion of chemotherapy/radiation

therapy; new enhancing lesion outside radiation field or; unequivocal evidence of viable tumor. Beyond 12 weeks

– new contrast enhancement outside field after decreasing stable or increasing dosing of corticosteroid.

Complete response—disappearance of all enhancing, measurable and non-measurable disease sustained for at

least 4 weeks. Partial response—stay with perpendicular diameter Progressive =to or> than 35% increase in sum

of products of perpendicular diameters of enhancing lesions compared to small tumor. (new revised criteria is

being developed) Surrogate Imaging—A. Gregory Sorenson Conventional methods—TI post gadolinium imaging;

volume versus cross sectional area; challenging in measurement reproducibility What does imaging tell us?

Attempts to distinguish radiation necrosis; often indistinguishable, swiss cheese pattern, crossing callosum not

always helpful Advanced methods—Does the tumor have high blood volume, lower diffusion, different metabolic

rates? Other newer techniques seeing to differentiate: Diffusion MRI (minimal scan time)—suggestive ADC

values (ratios in tumor are lower than in necrosis); looks promising, robust Perfusion MRI—thought to be

predictive, logical, but small sample sizes MR Spectroscopy—lots of promise, still no good multi center data FDG

(PET) or FLT or M-MI50 FLT is highly useful outside the brain and is basically like gadolinium. It is permeable and

limited Where do you draw measurement? Increase sensitivity of volume compared to the area.

Messages I will take to my constituency: Patient asymptomatic—you can watch and wait, follow patient and may

find decrease on the next scan, if so, it was pseudo progression. However because of the serious nature of GBM,

caution would need to be exercised. Criteria to determine progression: Within first 12 weeks after completion of



chemotherapy/radiation therapy; new enhancing lesion outside radiation field or; unequivocal evidence of viable

tumor.


Explain:

Additional topics:

Jeanne Young Session Info: 5/31/2009 Patient Advocate meeting with Johnson, Sandler, and Garber 0

Education, mentoring Hours credit: 1.00


Comment: Comment: Bruce Johnson, M.D.; Howard Sandler, M.D.; Judy Garber, MPH

Significant findings reported: For lung cancer patients, therapeutic medicine is given for maintenance after

treatment. Maintenance has proven beneficial for childhood leukemia and is given for 2 years. Children may do

better because of their young age and because their bodies have not been through as much. Dr. Johnson

discussed different drugs, Tarceva (erlotinib) /Avastin and Bevacizumab. Most adults tolerate 4-8 cycles of

treatment, however, the drugs become too toxic after that timeframe. These drugs delay time to progression.

Lung cancer is notorious for returning after 2-1/2 months. Maintenance may prolong PFS for 3 months before

recurrence. Eighty-five percent of lung cancer is non-small cell lung cancer (NSCLC). Avastin does seem to be

beneficial for squamous cell, breast, or colon cancer. Hematocrit builders have been shown to make tumors

grow. After lung cancer, genitourinary cancer is the 2nd most common cancer in men. Treatment for

genitourinary cancer includes hormone therapy. Removal of testosterone will stop cancer growth in prostate

cancer, however, the cells figure out how to use or even make testosterone to still grow. MDV3100 is a

compound that is used to prevent testosterone from binding effectively with the testosterone receptor. This has

been tested in animals and is in early human trials. These studies will move in to Phase II trials. Promising agents

need larger trials to validate findings however. Surgery for prostate cancer brings the PSA back to 0 levels and if

there is recurrence the PSA level begins to rise. If PSA does not rise quickly it is okay. If it is rapid the patient may

need radiation or hormonal therapy. Judy Garber, MPH, highlighted some of the comments from the plenary

session. Does PARP make chemotherapy more effective? TNBC patients who have been treated with carboplatin

and PARP demonstrated a better response and lived longer than those who only had chemotherapy. Drug safety

studies are needed. Normal cells should be resistant to PARP and we need to prove if PARP is really effective.

Patients with BRAC2 are hormone sensitive. In Poland, a study has shown that 4 treatments before surgery to

shrink the tumor has proven successful. A patient advocate inquired about how lung cancer patients can be

diagnosed for recurrence or simply diagnosed earlier. CT screening is a useful tool for early detection. They are

working toward developing profiles in blood, but have not quite evolved yet. Personalizing cancer care is the

direction we are moving toward.

Messages I will take to my constituency: I may draw from some of this information during Special Emphasis

panel reviews when discussing NSCLC, prostate cancer or breast cancer. I found this comment interesting:

“Removal of testosterone will stop cancer growth in prostate cancer, however, the cells figure out how to use or

even make testosterone to still grow. MDV3100 is a compound that is used to prevent testosterone from binding

effectively with the testosterone receptor.”


Explain:



Additional topics:

Jeanne Young Hours credit: 13.05



Cary Zahrbock Session Info: 5/29/2009 Fundamentals of Clinical Trial Design and Methodology 118



Comment: Presenter 5 was also Excellent!

Significant findings reported: This session was very effective at providing descriptions of Phase 0, I & II clinical

trials, the basic issues that can occur in interpreting statistics and basic analysis in clinical trial hypothesis and

analysis. I especially appreciated the discussion about the therapeutic misconception that the primary purpose

of clinical trials is for patient care rather than research. This is a key issue that requires diligence in the informed

consent process. The speakers reiterated that "Informed Consent" is a process, not a signature on a form. They

highlighted 3 phases of informed consent: 1. Patient must understand their disease & their clinical status. 2.

Patient must understand current standard of care as a treatment option. 3. Patient must understand the offered

clinical trial and potential impact on their disease. At each stage in this process, the person ensuring informed

consent must evaluate the patients understanding of each phase, and continue to work on understanding prior to

moving on.. I thought this was could provide very clear guidance to professionals and patients.

Messages I will take to my constituency: Think analytically when analyzing reports from clinical trial results.

Ensure support of a thorough informed consent process. The therapeutic misconception that the primary

purpose of clinical trials is for patient care rather than research. This is a key issue that requires diligence in the

informed consent process. The speakers reiterated that "Informed Consent" is a process, not a signature on a

form. They highlighted 3 phases of informed consent: 1. Patient must understand their disease & their clinical

status. 2. Patient must understand current standard of care as a treatment option. 3. Patient must understand

the offered clinical trial and potential impact on their disease. At each stage in this process, the person ensuring

informed consent must evaluate the patients understanding of each phase, and continue to work on

understanding prior to moving on.. I thought this was could provide very clear guidance to professionals and

patients.


Explain: I thought the webinars were consistent with this information and heightened awareness about issues in

clinical trials prior to ASCO.

Additional topics: I would suggest providing future participants the NCI book on clinical trials as I think it is such a

great resource and presents information in a very understandable format.

Cary Zahrbock Session Info: 5/30/2009 Opening Session w/ Presidential Address 213 Special Session Hours

credit: 2.50


Comment:

Significant findings reported: Access to genomic testing is increasing through decreased costs and increased

understanding of gene microarrays and guided treatments. Personalized care can support reduced cost of care

and negative side effects. ASCO is working to ensure oncology workforce and leadership development. ASCO

focus on Cost of Care - Reducing costs through research and TailoRX study. Palliative Care Task Force has created

a Survivorship Plan available through Cancer.net.



Messages I will take to my constituency: Leaders in cancer community very committed. Treatment specificity

improving, need to continue to support genome research. Survivorship plans are available on Cancer.net.


Explain:

Additional topics: None...

Cary Zahrbock Session Info: 5/30/2009 Economics of Cancer Care 246 Education Hours credit: 1.00


Comment: Found this session very interesting!

Significant findings reported: the first speaker presented statistics on the costs of health care in the US. The

most surprising and disturbing statistics were the ones that showed a huge gap in treatment and mortality

between the commercially insured, the uninsured and the Medicaid population. The surprise is that the Medicaid

population fell below the uninsured population in regards to treatment and mortality. Very concerning!

Appreciated the woman from the American Board of Internal Medicine who focused on the Physician Charter and

the need to ensure that the trust that has been placed in physicians is not lost. Three specific areas she focused

on were the conflict of the physician related to payment and service; the obligation of the physician and informed

decision making by patients. The final speaker presented information on economic costs of health care. Of

concern is that for every 10% premium cost increase, there is a .75% decrease in insurance coverage. The

employer contribution toward insurance has more than doubled in the past 25 years. Health care is #1 cost in

state budgets and spending on higher education is reduced due to increasing health care costs. We will need to

find ways to Lower prices and Lower intensity of service in order to reduce the impact of health care spending in

our economy. Discussed a focus by the Obama administration to reduce 30 day readmissions by paying for

services 30 day after hospital admissions. Goal is to ensure health care coverage for all americans.

Messages I will take to my constituency: Employer contribution toward health care costs have significantly

increased... Need to find ways to lower prices and lower intensity of services.


Explain: Didn't focus on this in preparatory sessions.

Additional topics: More data about health care expenses..

Cary Zahrbock Session Info: 5/31/2009 Plenary Session 333 Plenary Hours credit: 2.50


Comment: The genomics presentation was fabulous!

Significant findings reported: Clear explanation of genomics. Mutations are different for each patient, and there

are some mutations which are "passengers" and don't impact cancer development, others are "drivers". The

drivers are not necessarily all the same for each patient, but there are 12 Core pathways that mutations work.

Goal is to target these pathways to have more targeted therapies, identify pre-disposition for cancer, provide

treatment at very early stages and reduce impact form disease. Reported on clinical trial results related to



CA125 screening for ovarian cancer. Showed that treatment at early stages when CA125 increases does not

increase life expectancy over waiting to treat until clinical symptoms emerge. Also decreases quality of life..

Messages I will take to my constituency: Mutations are different for each patient, and there are some mutations

which are "passengers" and don't impact cancer development, others are "drivers". The drivers are not

necessarily all the same for each patient, but there are 12 Core pathways that mutations work. Goal is to target

these pathways to have more targeted therapies, identify pre-disposition for cancer, provide treatment at very

early stages and reduce impact form disease. Reported on clinical trial results related to CA125 screening for

ovarian cancer. Showed that treatment at early stages when CA125 increases does not increase life expectancy

over waiting to treat until clinical symptoms emerge. Also decreases quality of life..


Explain: The information on genomics helped me to understand this excellent speaker even more fully.

Additional topics:

Cary Zahrbock Session Info: 5/31/2009 Physical, Psychological & Cognitive Challenges 329 Education Hours

credit: 1.25


Comment:

Significant findings reported: There are current trials underway to learn more about late term effects -

specifically joint pain. A study on acupuncture showed significant improvement. Psychological challenges exist

for survivors - increased risk of depressive symptoms 4-8 yrs post diagnosis. Also at higher risk for suicide,

especially 5-10 years after diagnosis. Anxiety increases also, more generalized anxiety and some PTSS (Post

Traumatic Stress Symptoms), most don't meet the threshold for PTSD. Oncologists underestimate emotional

problems in most medically ill population. Dana Farber has developed a Health Behavior Assessment..

Cognitive functioning studies show varied results - but there is acknowledgement of memory loss, issues with

executive function, processing time and memory retrieval, especially for people who had chemotherapy. No

evidence currently on how to prevent or treat issues.

Messages I will take to my constituency: Studies continue to show survivors impacted by pain, depression,

anxiety, PTSS and cognitive losses. We need to continue to encourage study of these effects and gain more

understanding of how to prevent and treat the issues.


Explain: Preparatory information wasn't related to psychosocial issues, which is a strong interest of mine.


Cary Zahrbock Session Info: 6/1/2009 Palliation of Symptoms at the End of Life 442 Education Hours credit:

1.25


Comment:



Significant findings reported: People are not being adequately evaluated and treated for difficulty breathing

(Dyspnea) at end of life. There are many reasons for Dyspnea. Care givers need to assess on an ongoing basis and

be active in treatment. Presenter reviewed research re: most effective treatment and recommends: oxygen if

pulsoximetry < 90%. PRN Opioids, (education patients and caregivers about opioids). If opioids don't resolve

dyspnea completely, add anxiolytics. Second presenter focused on delirium at end of life. Interferes with

meaningful contact, distressing to families, may produce suffering in the moment and recall of delirium shown to

be distressing to patients, even when fragments of memory. The best screen is serial bedside clinical exam. Look

for potentially reversible causes. Recommendations for treatment depend on whether goal is resolution of

delirium or sedation. For resolution of delirium use older anti-psychotics, dose on schedule rather than PRN and

taper off after delirium abates. Use benzodiazepines or anesthetics when sedation is the goal. Third presenter

focuses on Pain management at end of life. Research showed that 95% of people reported pain, 78% received

treatment yet only 49% felt better after the treatment. Need to do a better job of pain control. Recommend

incorporation of pain management specialist into care team at end of life, use of opiods. Need to take

personalized approach to pain management. Concern that FDA project called "REMS" Risk Evaluation and

Mitigation Strateg" could reduce access to needed pain medications. Other recommendations that clinicians

think about metastasis sites and related pain. Radiation therapy may be very helpful to reduce pain of bone

metastasis.

Messages I will take to my constituency: Need to continue to advocate for improved care at end of life.

Specifically, need continued and improved evaluation of dyspnea, delirium and pain. Treatment needs to be

directed toward amelioration of these symptoms, clinicians and care givers need to discuss options and education

about use of opioids continues to be a need.


on this topic)

Explain:

Additional topics: none

Cary Zahrbock Hours credit: 10.75

Jerry Bauer Session Info: 5/29/2009 Fundamentals of Clinical Trial ...

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