ST.P ETER S CANCER CARE CENTER 2010A NNUAL REPORT€¦ · had just heartburn or indigestion,”...

ST. PETER’S CANCER CARE CENTER

2010 ANNUAL REPORT

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2010 ANNUAL REPORT

The mission of St. Peter’s Cancer Care Program is to provide quality cancer care. Guided by thespirit of the Sisters of Mercy, the values that provide direction to the program include:• Ministry with compassion and caring to thephysical, psychological and spiritual needsof cancer patients

• Respect for human life and the dignity of the individual

Dedicated to offering a continuum of services tosupport the optimal well-being of patients andtheir families, St. Peter’s Cancer Care Program iscommitted to the promotion of:• The art of caring, balanced with technology• Continuous improvement and innovation• Prudent use of resources• Excellence through collaboration with existing community organizations• Facilitation of access to care• Community and professional education

TABLE OF CONTENTS

MISSION STATEMENT1… Letter From Director

2… Survivor Profile

3… Cancer Program Activity Report

4… Cancer Data Management Activity Report

7… Pancreatic Cancer: Statistical Analysis

13… Pancreatic Cancer Review: Focus on Surgery

17… Pathology of Pancreatic Cancer

20… Clinical Trials and Pancreatic Cancer

23… Community Education and Outreach

May 2011

Dear Colleague:

I am pleased to forward to you the St. Peter’s Cancer Care Center’s Annual Report for 2010 focusingon the diagnosis and treatment of pancreatic cancer.

Since 1985, St. Peter’s has been continually accredited as a Comprehensive Community Cancer Care Program by the American College of Surgeons Commission on Cancer. In its 2010 survey ofthe program, the Commission commended the cancer center for its volume of cancer-related qualityimprovements, its prevention and early detection activities, and the quality of its data submissionsand published annual report.

St. Peter’s program is fully comprehensive, encompassing state-of-the-art screening and diagnostics, a full range of surgical, medical and radiological oncologic treatment options and expanded access toclinical trials.

St. Peter’s offers a full range of external beam, high dose brachytherapy (including MammoSite®) aswell as the pinpoint precision of Novalis® Shaped Beam stereotactic radiosurgery and radiotherapywhich can locate a tumor with sub-millimeter accuracy. St. Peter’s is the only health care facility inthe Capital Region to offer this technology.

If you would like additional information regarding the services offered at St. Peter’s, call our CancerInformation Line (518-525-1547) or visit our website at www.sphcs.org/CancerCareCenter.

Finally, I would like to thank all those involved in making this publication possible.

Sincerely,

Wayne HolmenDIRECTOR, CANCER CARE SERVICES

CANCER CARE PROGRAM 2010 ANNUAL REPORT 1

Colfels’ indigestion was actually asymptom of pancreatic cancer. A year later, the recently-retiredexecutive assistant is grateful for the action doctors took after theydiscovered a tumor at the entranceto her bile duct.

“I had never suffered from indiges-tion before, but this was not goingaway. So I went to my primary (Dr. Roy Fruiterman) and he did an ultrasound right there in theoffice,” said Colfels. “He told me, ‘I think there’s a problem in thegallbladder area, and I want you togo right to (St. Peter’s) Hospital. Iknow your home is on the way, sostop and get your daughter andbring her with you to the hospital.’”

“We were in the height of the swineflu epidemic, and Dr. Fruiterman’swaiting room was pretty full. Hecould have said, ‘Take someMylanta,’ and I would have gonealong with it because I thought Ihad just heartburn or indigestion,”Colfels recalled. “He was just soattentive to me.”

Colfels is thankful her physiciancoaxed her into going to St. Peter’sright away.

“They admitted me that day, andright from the start they took every-thing very seriously,” Colfels said.She thought it might only be hergallbladder when, after a series of

tests, a cancerous tumor was foundnear the entrance to her bile duct.

“My family and I were in shock.We had very little knowledge of thistype of cancer, but Dr. (Jason)Heckman came in within a fewhours and said, ‘This is what wesee, and this is what we have to do.’He gave me all the relevant statis-tics, and told me that I was anexcellent candidate for a Whippleprocedure. He was so confident thatit inspired me and my familyimmediately. Most of all, he gave ushope.”

“Part of my confidence in St. Peter’scomes from growing up on SouthMain Avenue, literally in the shad-ows of the hospital. I’d had a fewsurgeries there, and both my daugh-ters were born there. So there wasnever any question where I wantedto go.”

But in the interest of due diligence,Colfels and her family did a littlehomework before deciding upon acourse of action.

“I asked Dr. Fruiterman if I shouldbe looking into treatment at one ofthe larger metropolitan hospitals orcenters of excellence, and he said,‘Oh, no. You have some of the bestpeople in the world right here.’ My family and I felt so relieved toknow there was an outstandingcommunity of caregivers at

St. Peter’s Cancer Center, right herein our own backyard.”

“They’re a team,” adds Colfels.“The right arm always knows whatthe left arm is doing.”

Colfels had an adverse reaction to achemotherapy drug in the springand suffered from complicationsfrom radiation treatments. Butsince then, Colfels says she has beenfeeling good. A recent PET scancame back clear, she happily reported.

Continuing to work during herchemotherapy was important,Colfels said, “because I needed thatfocus.” Colfels is doing well andattributes her succesful recovery tothe support of co-workers, her family and everyone in St. Peter’sCancer Center.

“The team at the Cancer CareCenter – from the nurses and theaides, even the receptionists – theyknow who you are. They work withyou; they work with your family.”

“Cancer treatment certainly isn’tfun, but you don’t do it alone.Everyone at St Peter’s made me feel as if recovery was not just mypersonal goal, but our collectivegoal – as though we were all work-ing together to get me better.” �

Grab an antacid or call her primaryphysician? When Deanna Colfels experienced severe heartburn for thefirst time, she decided to call her doctor.

It was a decision that saved her life.Deanna Colfels

A Survivor’s Story

2 CANCER CARE PROGRAM 2010 ANNUAL REPORT

Cancer Program Goals for 2011:

• Apply for and achieve accredita-tion with the American Collegeof Radiation Oncology for theRadiation Oncology Program.

• Continue to collaborate towardaccreditation of the BreastCenter through the NationalAccreditation Program for BreastCenters.

• Ensure adequate resources forprogram growth.

• Pursue plans for maintainingtechnological currency andadvances.

• Further expansion of ClinicalResearch Department’s breadthof studies through cooperativeand privately funded groups.

• Integration of the Cancer CareCenter with the Master FacilitiesPlan. �

Cancer ProgramActivity Report


Arthur Sunkin, MDSt. Peter’s Cancer Care Program continues to offer acomprehensive range of cancer care services to adults inthe community and the region. The program remains the largestin the Capital Region. In its most recent complete reporting year(2009), St. Peter’s diagnosed and/or treated 2,148 new (analytic) cancer cases and participated in the care of an additional 519 (non-analytic) cases. St. Peter’s Cancer Committee continues to provide direction and oversight to the program.

Among the recent accomplishments of the program are:

• Successful completion of American College of SurgeonsCommission on Cancer Reaccreditation Survey.

• Recruitment of an additional Medical Oncologist and BreastSurgeon.

• Continued growth in both stereotactic radiotherapy and radio-surgery in Radiation Oncology.

• Continued support of cancer education, outreach and preventionservices for affected populations in the community, such as cancer screenings, health fairs, support groups and the cancerinformation phone line.

• Implementation of major information technology infrastructure,moving toward a fully electronic medical record in line with thefive-year technology growth strategy.

• Attained membership in the National Cancer Institute sponsoredcooperative groups, American College of Surgeons OncologyGroup and Radiation Therapy Oncology Group, and successful-ly began recruitment of patients into clinical trials.

• Continued patient experience outcomes data at greater than the95th percentile.

• Addition of breast patient navigation and integration betweenthe comprehensive Breast Center and the Cancer Care Center.

Arthur Sunkin, MDCANCER COMMITTEE CHAIR

The Cancer Data ManagementDepartment at St. Peter’smaintains the Cancer Registrydatabase. During 2009, the registry collected data on 2,676new cases. This case volume repre-sents a 5% case increase over theprevious year’s volume of 2,541.The following graph indicates thefive-year growth in all accessionedcases.

Cancer Data Management Activity Report

Registry data are submitted weeklyto the New York State CentralCancer Registry, and annually to theCommission on Cancer’s NationalCancer Database.

St. Peter’s Cancer Committee provides direction and oversight ofregistry activities. The QualityImprovement Manager runs day-to-day operations of the department.All data abstraction on cases is performed by tumor registrars certified through the NationalCancer Registrar’s Association.

CANCER REGISTRY ACTIVITIES

The Cancer Committee employsregistry data to determine areas ofneed, and establishes program goalsand objectives. In addition, theCancer Care Quality Improvementprogram regularly uses registry data

to assess program-specific diseaseincidence and to document the efficacy of treatment outcomes.Community outreach efforts are also data driven. The need for educational programs, screeningsand participation in regional events,as well as requirements for new technology are given weight fromregistry incidence data.

In addition to maintaining currencyof the Cancer Database, the depart-ment also facilitates regular TumorConferences, interdisciplinaryforums for prospective case presenta-tion, AJCC staging discussion,and treatment determination.Current conferences focus on breast,thoracic, gastrointestinal tract, genitourinary tract, gynecological,and hepatobiliary sites. Surgeons,radiation and medical oncologists,diagnostic radiologists and patholo-

gists, as well as other practitionersattend tumor conferences. In 2009,585 patient cases were discussed at107 tumor conferences.

QUALITY OF CANCER DATA

The quality of cancer data abstrac-tion is monitored and reported regularly to the Cancer Committee.Registry quality monitoring activi-ties include:

• Inter-reviewer and physicianreview of a minimum of 10%of annual analytic abstracts.These audits identify addition-al training and resource needs.

• Timeliness of case abstractionand completion is monitoredand reported to both theCancer Committee and theNew York State CancerRegistry.

Kelly Washington, CTR, ST. PETER’S CANCER REGISTRY

4 CANCER CARE PROGRAM 2010 ANNUAL REPORT CANCER CARE PROGRAM 2010 ANNUAL REPORT 5

5-Year Cancer Registry Activity

• Annual follow-up of at least 90% of all active cases to ensure that up-to-date health status and survival information is in the database.

• Regular coding edits check for format accuracy. Inter-field edits ensure internal data consistency within records.

• Registrar attendance at continuing education and training sessions.

Lip 2 0.1% 3 0.10% ⇔Tongue 17 0.7% 21 0.80% ⇑Salivary Glands 8 0.3% 5 0.20% ⇓Floor of Mouth 1 0.0% 3 0.10% � ⇑Gum & Other Mouth 6 0.2% 2 0.10% ⇓Nasopharynx 2 0.1% 1 0.00% ⇓Tonsil 1 0.0% 5 0.20% � ⇑Oropharynx 2 0.1% 2 0.10% ⇔Hypopharynx 1 0.0% 9 0.30% � ⇑Other Oral Cavity & Pharynx 3 0.1% 3 0.10% � ⇔Esophagus 24 0.9% 35 1.30% � ⇑Stomach 25 1.0% 23 0.90% � ⇓Small Intestine 12 0.5% 10 0.40% � ⇓Colon Excluding Rectum 151 5.9% 100 3.70% � ⇓Rectum & Rectosigmoid 51 2.0% 50 1.90% � ⇓Anus, Anal Canal & Anorectum 9 0.4% 13 0.50% � ⇑Liver & Intrahepatic Bile Duct 21 0.8% 27 1.00% � ⇑Gallbladder 3 0.1% 4 0.10% � ⇑Other Biliary 11 0.4% 16 0.60% � ⇑Pancreas 73 2.9% 101 3.80% � ⇑Retroperitoneum 0 0.0% 2 0.10% � ⇑Peritoneum, Omentum & Mesentery 9 0.4% 13 0.50% � ⇑Other Digestive Organs 8 0.3% 4 0.10% � ⇓Nasal Cavity, Middle Ear & 1 0.0% 2 0.10% � ⇑Accessory SinusesLarynx 19 0.7% 14 0.50% � ⇓Lung & Bronchus 304 12.0% 364 13.60% � ⇑Trachea, Mediastinum & Other 4 0.2% 2 0.10% � ⇓Respiratory OrgansSoft Tissue (including Heart) 8 0.3% 8 0.30% � ⇔Skin exluding basal & Squamous 33 1.3% 51 1.90% � ⇑Basal/Squamous cell carcinomas of Skin 1 0.0% 1 0.00% � ⇔Breast 405 15.9% 441 16.50% � ⇑Cervix Uteri 56 2.2% 65 2.40% � ⇑Corpus & Uterus, NOS 260 10.2% 272 10.20% � ⇑Ovary 121 4.8% 105 3.90% � ⇓Vagina 8 0.3% 4 0.10% � ⇓Vulva 39 1.5% 44 1.60% � ⇑Other Female Genital Organs 13 0.5% 20 0.70% � ⇑Prostate 288 11.3% 233 8.70% � ⇓Testis 20 0.8% 10 0.40% � ⇓Penis 2 0.1% 3 0.10% � ⇑Urinary Bladder 116 4.6% 109 4.10% � ⇓Kidney & Renal Pelvis 56 2.2% 70 2.60% � ⇑Ureter 3 0.1% 6 0.20% � ⇑Other Urinary Organs 6 0.2% 5 0.20% � ⇓Eye & Orbit 0 0.0% 1 0.00% � ⇔Brain 9 0.4% 17 0.60% � ⇑Other Nervous System 9 0.4% 38 1.40% � ⇑Thyroid 111 4.4% 93 3.50% � ⇓Other Endocrine (including Thymus) 3 0.1% 9 0.30% � ⇑

SPH CANCER INCIDENCE BY SITE: 2009

Primary Site 2008# cases

2008 %of all cases

2009# cases

2009 %of all cases

Change from‘08 to ‘09


Lymphomas 81 3.2% 107 4.00% � ⇑Multiple myelomas 18 0.7% 20 0.70% � ⇑Leukemias 22 0.9% 26 1.00% � ⇑Mesothelioma 7 0.3% 8 0.30% � ⇑Kaposi Sarcoma 0 0.0% 3 0.10% � ⇓Miscellaneous Sites 78 3.1% 71 2.70% ⇑Total Cases 2,541 2,676 �

Of the new cancer cases seen in 2009, breast cancer continues to be the most commonly occurring cancer at SPHrepresenting 24%, followed (in descending order) by lung (19%), corpus uteri (14%), prostate (12%), ovary (6%),bladder (6%), colon (5%), thyroid (5%), pancreas (5%), and other (4%). The relative proportions of cancers by site are shown. �


Top 10 Cancer Sites 2009

Primary Site 2008# cases

2008 %of all cases

2009# cases

2009 %of all cases

Change from‘08 to ‘09


Pancreatic Cancer atSt. Peter’s Hospital:Statistical Analysis

REPORT PARAMETERS

This report presents an overview of the St. Peter’sHospital experience in diagnosing and treatingpancreatic cancer, and examines how this experi-ence compares with other hospitals, both state andnationwide. The primary data source for this report isthe database maintained by St. Peter’s Cancer DataManagement Department in its Cancer Registry of can-cer cases encountered and documented at SPH. Cancerregistrars in this department collect data on all identifiedcases of cancer that are diagnosed and/or treated at theinstitution. These data are compiled according to theFacility Oncology Registry Data Standards (FORDS)established by the Program’s accrediting body, theAmerican College of Surgeons Commission on Cancer(ACoS-CoC).

FORDS establishes criteria for designating cases as eitheranalytic or non-analytic. Analytic cases have a significantproportion of their diagnosis and/or treatment done atthe reporting institution. Only analytic cases were count-ed in compiling case volumes for this report. Dependingon the context of comparison, these data may encompassvarious time periods. Date ranges throughout this reportare clearly identified.

Data submitted to the Commission on Cancer (CoC) byaccredited programs across the country are aggregated

into National Cancer Database (NCDB) BenchmarkReports. These site-specific reports encompass data from2000 through 2008. For this report, aggregates of allnine years’ data were used to obtain a meaningful localsample size.

For the nine-year period evaluated, 1,394 hospitalsacross the U.S. reported a total of 213,979 cases of pan-creatic cancer. During that same period, 199 hospitalswithin New York State reported 14,152 cases while St. Peter’s reported 437 cases. Proportional (relative percent) rather than numerical data have been used inmuch of this report to allow comparison between thesedisparately sized data cohorts.

PANCREATIC CANCER INCIDENCE AT ST. PETER’S

St. Peter’s Cancer Registry began tracking cancer cases in1985. Between then and 2009 (the last complete year ofdata collected), St. Peter’s Cancer Care Center diagnosedand/or treated 800 analytic cases of pancreatic cancer.The volume of analytic cases is broken down by stage, asseen below. Stage 0 is also known as cancer in situ. Thereare some histological grades of pancreatic cancer that arenot necessary to stage by AJCC guidelines. These gradesare denoted by N/A throughout the report. The largestproportion of cases present as Stage IV disease.

Kate Corcoran, MPH, QUALITY IMPROVEMENT MANAGER

Stage at Diagnosis 0 1 II III IV N/A Unknown

Volume of SCLC Analytic Cases 5 91 132 96 279 25 172

Percent by Stage 0.6% 11.4% 16.5% 12.0% 34.9% 3.1% 21.5%

*N/A represents cancers by histology that are not necessary to stage by AJCC guidelines.

Kate Corcoran

Table 1

In the most recent 10-year period, including the most recent complete year of data (2009), new analytic cases of pancreatic cancer are trending upwards. In mid-2008, a dedicated Hepatobiliary surgeon, Dr. Jason Heckman arrived at St. Peter’s, which resulted in a 45% increase of cases. The average increase over the 10-year period was 16%, with twomarked increases between 2000-2001 and 2008-2009. The incidence data for the 10-year historical period are depictedin Figure 1.

DEMOGRAPHIC FACTORS

INCIDENCE BY AGE AT DIAGNOSIS

Nationally, over 55% of patients are diagnosed withpancreatic cancer between the ages of 60 and 80.This percentage carries through to both NYS and St. Peter’s data. Very few patients are diagnosed underthe age of 40 (See Table 2).

SURVIVAL FOR PANCREATIC CANCER

An examination of overall, relative survival by those diagnosed at SPH reveals a five-year survival rate of 0.3%. Thetotal population at risk was 449 people, with eight still alive after five years. (See Figure 2). Survival data at SPH isdependent on follow-up data obtained by the return mailed letters to patients and physicians.


Figure 1

Age at Diagnosis Pancreatic Cancers by Age

SPH % NYS % US %

< 20 0.0 0.0 0.0

20-29 0.0 0.1 0.2

30-39 0.7 0.9 1.1

40-49 3.9 5.8 6.0

50-59 17.9 16.2 16.7

60-69 29.1 24.4 25.2

70-79 30.2 31.0 30.4

80-89 15.3 18.3 17.9

90+ 3.0 3.2 2.6Table 2

10-Year SPH Pancreatic Cancer Incidence


INCIDENCE BY RACE

As a proportion of overall cases, the Caucasian population is most heavily affected by pancreaticcancer. Caucasians represent a slightly higher proportion of total patient numbers in St. Peter’spopulation than is reported in both the state andthe nation. The group with the fewest incidentalcases at St. Peter’s is Native Americans, however, theincidence of pancreatic cancer in Native Americansappears to also be the lowest at the state andnational levels as well. The greatest disparity betweenthe St. Peter’s population and the rest of the state andthe nation is between Caucasian and African American populations. St. Peter’s sees approximately one thousand foldfewer African American patients than the national and state burden of pancreatic patients. (See Table 3).

HOUSEHOLD INCOME AND INSURANCE

COVERAGE

INCIDENCE BY HOUSEHOLD INCOME

The data at the right illustrates relative frequency of pancreatic cancer by household income for thenine-year reporting period.

The St. Peter’s population with pancreatic cancer andwith an annual household income between $39,000 and $48,999 comprise the largest proportion of cases, except forthe data “not available” category. A larger proportion of people from households earning $33,000 to $38,999 are diag-nosed within New York state and nationally. Households with incomes less than $28,000 have the lowest percentage of pancreatic cancers across all three cohorts. It is difficult to draw conclusions on the relationship of income to pancreaticcancer incidence due to the high percentage (nearly 50%) of unavailable data at the state and national levels. (See Table 4).

Figure 2

Incidence by Race Pancreatic Cancers by race

SPH % NYS % US %

Caucasian 92.9 76.4 79.5

African American 3.9 12.3 11.6

Hispanic 0.7 5.7 4.6

Asian/Pacific Islands 0.2 2.8 2.3

Native American 0.0 0.1 0.2

Other/Unknown 2.3 2.8 1.8

Table 3

Overall Relative Survival

Income Pancreatic Cancers by Income

SPH % NYS % US %

< $28,000 0.5 0.7 0.5

$28,000 – $32,999 5.5 6.8 7.3

$33,000 – $38,999 9.6 17 16.3

$39,000 – $48,999 10.1 11.3 11.1

Not Available 25.4 48.1 46.6

Table 4

INCIDENCE BY INSURANCE COVERAGE

Data summarizing health insurance coverage for thispopulation tends to follow the regional disparities inhousehold income described previously. The largest proportion of patients seen at St. Peter’s, within thestate, and nationally, are served by Medicare withSupplement (Medicare with an additional private insurance coverage). In these nine years of data, thereseems to be a large disparity between the Medicare with Supplement population and those with otherinsurance coverage, other than Managed Care,although, St. Peter’s sees a greater relative percentage of managed care patients than at the state and nationallevels. The state and national numbers for Medicare aresignificantly higher than the population at St. Peter’s. In addition, less than two percent of patients seen at St. Peter’s are without insurance coverage. (See Table 5).

DISEASE-RELATED FACTORS

MORPHOLOGY

Morphology refers to the histological classification of thecancer tissue and a description of the course of develop-ment that a tumor is likely to take: benign or malignantbehavior. The designation is based on a microscopicdiagnosis of morphology by a pathologist. Not otherwisespecified (NOS) is a categorization which is used inaccordance with College of American Pathologists current protocols.

Both nationally and in the state, the largest proportionof pancreatic cancers, after ‘other specified types’ areAdenocarcinoma, NOS, followed by Infiltrating DuctCarcinoma. At St. Peter’s, Infiltrating Duct Carcinomais the most frequently seen histology followed byAdenocarcinoma, NOS. Neoplasm, NOS is the smallesthistological category across all three cohorts. (See Table 6).

STAGE AT DIAGNOSIS

Cancer stage at diagnosis is a strong predictor of diseaseoutcomes. Proper clinical staging of cancer allows thephysician to determine appropriate treatment options.The Cancer Registry monitors the use of stage in treat-ment planning and records physician assigned clinicaland pathologic staging in the registry database. In caseswhere clinical information related to stage is absent orunavailable, a stage designation of “unknown” isassigned.


Histology Pancreatic Cancers by Histology

SPH % NYS % US %

Neoplasm, NOS 0.5 0.7 0.5

Carcinoma, NOS 5.5 6.8 7.3

Adenocarcinoma, NOS 9.6 17 16.3

Infiltrating Duct Carcinoma 10.1 11.3 11.1

Other Specified Types 25.4 48.1 46.6

Table 6

Table 5

Insurance Pancreatic Cancers by Insurance Type

SPH % NYS % US %

Not Insured 1.6 1.5 2.9

Private Insurance 6 8.1 9.6

Managed Care 30.9 25 22.3

Medicaid 4.1 6 3.9

Medicare 8.5 19.2 17.5

Medicarew/Supplement

48.5 36.3 37.9

Veterans Affairs 0 1.8 1.7

TRICARE/Military 0 0.1 0.6

Indian/PublicHealth Service

0 0 0.1

Unknown 0.5 2 3.5

INCIDENCE BY STAGE

The following data demonstrates relative frequency ofpancreatic cancer by stage at time of diagnosis forreporting years 2000-2008 from NCDB data.

A review of stage data, represented in Table 7, revealsthat a much larger percent of unknown stage is report-ed at St. Peter’s than in the comparable state or nation-al cohorts. This tends to depress the relative percent ofgroups with known stages. The largest percentage ofpatients present with Stage IV disease across all threegeographic groups. Stage II is the second largest groupfor the state and nation, however, Stage III is the second largest group for St. Peter’s. In fact St. Peter’sreports a greater proportion of unknown stage cancersthan either the state or nation. However, among otherstages, there is minimal discrepancy between St. Peter’s,the state, and the national level.

TREATMENT

INCIDENCE BY FIRST COURSE OF TREATMENT

Relative frequency of initial treatment modalities isshown below:

The treatment patterns across all three groups are verysimilar. The highest percentage of first course treatmentacross all three cohorts was “No 1st Course Treatment”followed by “Chemotherapy Only”. The smallest per-centage of patients have “Surgery and Chemotherapy”followed by “Surgery, Radiation, and Chemotherapy” for all three groups. (See Table 8)

SURVIVAL BY SURGERY OF PRIMARY SITE

Figure 3 illustrates five-year relative survival rates by surgery of primary site. The graph depicts the Whippleprocedure, commonly used to treat most pancreatic cancers versus no surgery. Note that 48 patients were at risk after undergoing a Whipple procedure whereas353 were at risk with having no surgical resection. Thesurvival rates indicate that having surgery for pancreaticcancer slightly increases survival. The five-year survivalafter surgery is 2% as opposed to 0.4% without surgery.

INCIDENCE OF TREATMENT WITH RADIATIONTHERAPY

The data below looks at the range of radiation therapymodalities delivered in treating pancreatic cancer.

More than 80% of patients are not treated with anyform of radiation therapy for all three geographic areas.St. Peter’s has a slightly higher percentage of patientsthat are not treated with any form of radiation than thestate and national populations. The second largest groupis those treated with beam radiation, of which the

Stage at Diagnosis Pancreatic Cancers by Stage

SPH % NYS % US %

0 0.5 0.7 0.5

I 5.5 6.8 7.3

II 9.6 17 16.3

III 10.1 11.3 11.1

IV 25.4 48.1 46.6

NA 0 0.1 0.1

UNK 50 16.1 18.2

Table 7


Table 8

First Course Therapy Pancreatic Cancers byFirst Course Therapy

SPH % NYS % US %

Surgery Only 9.6 9.1 9.4Surgery & Chemotherapy 2.8 3.7 2.9

Radiation & Chemotherapy 8.9 8.7 9.7

Chemotherapy Only 20.8 24.9 23.5

Surgery, Radiation, &Chemotherapy

3.7 4.5 6.3

Other Specified Therapy 13.3 7.5 5.5

No 1st Course Treatment 41 41.6 42.6

Survival by Surgery of Primary SiteFigure 3

SUMMARY

To summarize the observations and conclusions of this dataanalysis:

• St. Peter’s reported 437 cases of pancreatic cancer between2000 and 2008.

• Since 2000, the number of cases of pancreatic cancer hasbeen on an upward trend with an average increase of 16% per year. The largest increases occurred between2000-2001 and 2008-2009.

• Over 55% of patients diagnosed with pancreatic cancernationally are between the ages of 60 and 80. Less than 2%of patients are diagnosed under the age of 40.

• The St. Peter’s population with pancreatic cancer and withannual earnings between $39,000 and $48,999 comprisethe largest proportion of cases, except for the data “notavailable” category. A larger proportion of people fromhouseholds earning $33,000 to $38,999 are diagnosed within the state and nationally.

• A review of stage data reveals that a much larger percent ofunknown stage is reported at St. Peter’s than in the compa-rable state or national cohorts. This tends to depress the relative percent of groups with known stages. The largestpercentage of patients present with Stage IV disease acrossall three geographic groups.

• Optimal survival rates are seen for those treated with surgery at 2% compared to a 0.4% survival rate for thosewho did not have surgery.

• The greatest proportion of patients are not treated with anyform of radiation therapy across all three cohorts. Of thosepatients who are treated with radiation, beam radiation is thelargest category.

• The majority of patients, greater than 50%, do not undergosystemic therapy for pancreatic cancer. The second largestgroup of patients receives chemotherapy alone. �


Table 10

Systemic Therapy Pancreatic Cancers bySystemic Therapy

SPH % NYS % US %

No Systemic Therapy 52.2 52.9 54.5Chemotherapy Alone 36.2 41.7 42.5

Hormone Therapy 0 0.1 0.1

Immunotherapy Alone 0.2 0.3 0.1

Chemotherapy and HormoneTherapy

0.2 0.2 0.2

Chemotherapy andImmunotherapy

0 0.9 0.5

Hormone Therapy and

Immunotherapy

0 0.02 0

Systemic Therapy, NOS 11.2 3.9 2.1Unknown if Systemic Therapy

Administered0 0.01 0.02

national population has a larger percentage of patientstreated with beam radiation than St. Peter’s and thestate. All other categories for radiation treatment individually represent less than 1% of the total popu-lation for all three cohorts. (See Table 9).

INCIDENCE OF TREATMENT WITH SYSTEMICTHERAPY

Various combinations of chemotherapy, hormonetherapy, and immunotherapy comprise the systemictherapies available for treating pancreatic cancer. Thedata illustrates relative frequency of pancreatic cancertreatment with systemic therapy across the geographiccohorts.

The majority of patients, greater than 50%, do notundergo systemic therapy for pancreatic cancer. The second largest group of patients receives chemothera-py alone. St. Peter’s sees a lower percentage of patientsreceiving “Chemotherapy Alone” than New York state and within the nation, which is offset by a high-er percentage in the category of “Systemic Therapy,NOS.” Less than 1% of patients are treated with vari-ous combination therapies or with hormone therapyor immunotherapy alone. (See Table 10).

Radiation Treatment Pancreatic Cancers byRadiation Treatment

SPH % NYS % US %

No Radiation Treatment 85.4 84.0 80.7Beam Radiation 13.7 15.1 18.3

Brachytherapy 0.2 0.1 0.1

Radiation Therapy, NOS 0.5 0.6 0.5

Uknown if RT Recommendedor Administered

0.2 0.3 0.4

Table 9


INTRODUCTION

Cancer of the pancreas is the 10th most common cancer in the United States, and ranks fourth indeath rate. For pancreatic ductal adenocarcinomathere were an estimated 38,000 new cases and34,000 deaths in 2008. The incidence and mortalityhave not changed significantly over the last three decadeswith an incidence of 11.7/100,000 and death rate of10.7/100,000 (Figure 1). Lifetime risk of developing pancreas cancer is 1 in 71. Pancreatic cancer affects older people more commonly than younger, with themedian age at diagnosis of 72 years.

Surgery combined with chemotherapy and possibly radiation therapy is the only potentially curative treat-ment for pancreatic cancer. Unfortunately, at the time ofdiagnosis only 20% of patients are candidates for surgicalintervention. The five-year survival for these patientswho undergo surgery is 20%. The five-year survival forpatients diagnosed with pancreas cancer including allstages is 3%. For example, if there are 100 patients withpancreas cancer, 20 will have surgery and only fourpatients will be alive at five years. These statistics havenot changed much over the past 30 years. This year it isexpected that 43,000 people will be diagnosed and37,000 will die. The goal of this article is to give anoverview of the biology, diagnosis, staging, and treatmentof pancreatic cancer. In addition, it will focus on the surgical treatment at St. Peter’s Hospital.

BIOLOGY OF PANCREATIC CANCER

The etiology of pancreatic cancer remains elusive. Likely,there is a culmination of multiple factors including environmental and genetic. There are multiple lifestylechoices that potentially may play a role in the develop-ment of pancreas cancer. The strongest linking risk factor is tobacco smoking. Smokers are 2.5 to 3.6

times more likely to develop pancreas cancer than non-smokers. Alcohol use, obesity, high fat diet, and diabetesare other potential risk factors. It is estimated that a family history of pancreas cancer doubles the risk ofdevelopment of the disease. There are rare genetic syndromes that confer an increased risk. People withblood type O may have a reduced risk of developingpancreas cancer, as discovered within the last two years.None of these risk factors are the “smoking gun” butmay offer insight into the underlying biology of the disease.

Like most other adenocarcinomas, or cancers arisingfrom the endothelium of gland-forming tissues, pancre-atic cancer goes through a series of gene mutations toform an overt cancer. Pancreatic intraepithelial neoplasiaand intraductal papillary mucinous neoplasm are precan-cerous lesions that lend support to a successive genemutation theory. The process of going from minimallyatypical cells to overtly dysplastic cells and finally toinvasive cancer follows a series of known and unknownmutations. These include mutations in oncogenes suchas KRAS2, tumor-suppressor genes such as CDKN2A,TP53, and SMAD4. Most patients with pancreatic cancer have these gene mutations. Pancreatic cancer stem cells and the characteristic desmoplastic reactionsurrounding a pancreatic cancer also play a major role in the formation and maintenance of pancreas cancer.This is a complex process and these concepts likely only scratch the surface of the underlying biology ofpancreatic cancer.

DIAGNOSIS OF PANCREATIC CANCER

Most tumors arise in the head of the pancreas.Accordingly, the most common presentation for pancreas cancer is obstructive jaundice. Tumors in theneck, body, or tail often present with larger tumors andominous symptoms of pain and weight loss. Pancreaticcancer should be in the differential diagnosis in a patient

Pancreatic Cancer Review:Focus on Surgery

Jason T. Heckman, MD, FACS

ATTENDING SURGEON, ST. PETER’S HOSPITAL

ALBANY LIVER AND PANCREAS SURGERY

Jason Heckman, MD


with pancreatitis without any other obvious etiology.New onset diabetes, especially in an older patient shouldalso raise suspicion of pancreas cancer. The single besttest in the initial stages of diagnostic work up is biphasic(arterial and portal venous phase), contrast-enhancedcomputed tomography (CT). CT predicts resectabilitywith 90% accuracy. Contrast magnetic resonance imag-ing is useful in patients who cannot get CT. Positronemission tomography (PET) has not been validated as auseful tool for the initial staging of pancreatic cancer.However, PET may be useful for ruling out unsuspectedmetastatic disease. Endoscopic ultrasound (EUS) andendoscopic retrograde cholangiopancreatography(ERCP) are tools to obtain tissue for biopsy and to place a stent to relieve jaundice. Serum markers such ascarbohydrate antigen 19-9 (CA 19-9) are important forprognostic purposes but do not play a role in diagnosisor screening.

STAGING OF PANCREATIC CANCER

Stage grouping in pancreas cancer is broken down bysurgical resectability (Figure 2). T1, T2, and T3 tumorsare considered resectable. T4 lesions, or tumors thatencase the celiac or superior mesenteric artery, are considered locally advanced and unresectable. Stage IVpatients have metastatic disease and are unresectable.The staging system accurately predicts survival withworsening survival for increasing stage. Five percent ofpatients are considered borderline resectable when thetumor abuts (comes in contact with but does not sur-round) the celiac or superior mesenteric arteries, or thereis focal involvement of the superior mesenteric vein orportal vein. These patients benefit from preoperative(neoadjuvant) therapy with chemotherapy and radiation.

Staging of Pancreatic Cancer*

Stage TumorGrade

NodalStatus

DistantMestastases

MedianSurvival†

Characteristics

mo

1A T1 N0 MO 24.1 Tumor limited to the pancreas, <2 cm in longest dimension

1B T2 N0 M0 20.6 Tumor limited to the pancreas, >2 cm in longest dimension

11A T3 N0 M0 15.4 Tumor extends beyond the pancreas but does not involve the celiac axis or superior mesenteric artery

11B T1, T2 or T3 N1 M0 12.7 Regional lymph-node metastasis

111 T4 No or N1 M0 10.6 Tumor involves the celiac axis or the superior mesentericartery (unresectable disease

1V T1, T2 T3 or T4 N0 or N1 M1 4.5 Distant Metastasis

* N denotes regional lymph nodes, M distant metastases, and T primary tumor.† Data are from Bilimorial et al.45

Figure 1

Figure 2

Source: National Cancer Institute


TREATMENT OF PANCREATIC CANCER

The treatment decisions for patients with pancreas can-cer are complex. A multidisciplinary group of physiciansand support staff need to integrate and communicateabout each management decision. This includes: a pan-creas surgeon, medical oncologist, radiation oncologist,gastroenterologist, and radiologist. Pancreatic surgery is complex and technically challenging. It requiresadvanced training. The most commonly performed surgical procedures for pancreatic cancer are pancreatico-duodenectomy (Whipple procedure) for tumors in thehead of the pancreas, and distal pancreatectomy fortumors in the body or tail. Surgical morbidity and mortality has decreased significantly over time. Now apatient can expect a mortality of 2% and morbidity of30%. The volume of pancreatic surgery performed bythe surgeon and the hospital impact the morbidity andmortality. High volume surgeons and hospitals have thebest outcomes.

There is no role for surgery in locally advanced diseaseor metastatic disease, as surgical intervention does notchange the overall prognosis. Invasion of the portal veinor superior mesenteric vein does not preclude surgicalresection. Enbloc resection of the vein along with thetumor, and venous reconstruction if technically possibleyields the same survival as compared to patients withoutvein involvement. In only very selective cases is resectionof major arterial structures indicated. The significantdistinction between resection of the venous structuresand arterial structures is likely due to the rich lymphaticand nervous tissue that surrounds the arterial structuresand facilitates tumor extension and metastases. Thevenous structures lack this lymphatic and neural plexus.

Risk factors for recurrence after surgical resectioninclude: poor tumor differentiation, tumor size greaterthan 2 cm, involvement of lymph nodes, and involvedsurgical margins. Because the results after resection aloneare poor, multiple trials of adjuvant chemotherapy andradiation therapy have been conducted. Results havebeen mixed. A trend toward longer overall survival and longer disease-free intervals has been established.The current standard treatment has emerged as eithergemcitabine (a nucleoside analogue that blocks DNAreplication) alone, or combined with fluorouracil (aninhibitor of thymidilate synthetase) based chemoradia-tion following surgical resection. A median survival of20 to 22 months and a five-year survival of 20% can beexpected with a combination of surgery and chemo-therapy.

Because 80% of patients present with metastatic diseaseor have locally advanced cancers at the time of diagnosis,palliative regimens are crucial, such as hospice care,chemotherapy, and experimental chemotherapy trials.All chemotherapy regimens are based on gemcitabine.Active treatment in patients who are unresectable yieldsa modest gain in survival. The median survival for thisgroup of patients is six to 12 months with few long-termsurvivors.

SURGICAL EXPERIENCE AT ST. PETER’S HOSPITAL

Since 2008 there has been a 45% increase in the numberof cases of pancreatic cancer treated at St. Peter’sHospital. This increased volume is due to the formationof the multidisciplinary liver and pancreas center at St. Peter’s. Included in this effort is a designated liverand pancreas surgery database. This was instituted totrack outcomes and improve quality of surgical care.This database tracks surgical resection for all pancreasconditions. A total of 99 (51 Whipples, 41 distal, seventotal pancreatectomy or enucleation) resections havebeen performed from 2008–2010. The average length ofstay was 8.5 days. Intensive care utilization was 4.9%.Nineteen patients were treated in the ICU at some timein the post-operative course. Most patients were admit-ted to the hospital ward. Average blood loss was 226.5mL. Transfusion rate was 9.1%. Surgical resection mar-gin for cancer patients was 81.8% R0, 18.2% R1, and 0 R2. Surgical mortality at 90 days was 1% (n=99). This death was due to an underlying pulmonary condition.Re-operation was necessary in two patients (2%). Theseoutcome parameters are equivalent or better than thosereported in the medical literature (Table 1).

Summary of Surgical Outcomes at SPH

SPH Medical Literature

Average LOS 8.5 days 10 days

ICU Utilization 4.9% –

Average EBL 226.5 mL 700mL

Transfusion rate 9.1% 47%

R0 Resection rate 81.8% 80%

Reoperation 2% –

90-day mortality 1% 2-3%

Table 1

N=99LOS=Length of stayICU=Intensive Care Unit

EBL=Estimated blood lossR0=No residual tumor


Figure 3 Jason Heckman, MD, performsWhipple surgery – the most common type of surgery forpancreatic cancer. During theprocedure, the head, and some-times the body of the pancreasis removed. It also includesremoval of the duodenum andgallbladder, part of the jejunum,stomach bile duct and lymphnodes near the pancreas. Theremaining bile duct is thenattached to the small intestineto allow bile from the liver tocontinue entering the smallintestine. Whipple surgery is acomplicated process, andrequires a great deal of skill.

SUMMARY

Treatment of pancreatic cancer is challenging. Wehave not had much impact on survival for thoseafflicted with this cancer. Treatment strategy includessurgical resection and chemotherapy, possibly withthe addition of radiation treatment (Figure 3). The surgical management for pancreas cancer has reached a plateau. There have been crucialimprovements in surgical techniques which haveconsiderably improved the mortality and reducedcomplications, as well as expanding the number ofpatients who can have surgery. There are minorimprovements that can be made to surgical tech-nique at this time, as surgery is necessary but notsufficient in the treatment of pancreatic cancer.Improvement in survival for pancreatic cancer willcome from breakthroughs in early screening anddetection, perioperative chemoradiation strategies,and new targeted chemotherapy drugs. �

1. National Cancer Institute, SEER Database,

http://seer.cancer.gov/statfacts/html/pancreas.html

2. Hidalgo M. Medical progress, pancreatic cancer. N Engl J Med 2010;362:1605-17.


Pathology ofPancreatic Cancer

INTRODUCTION

Classification of pancreatic neoplasms is based onthe line of differentiation of the tumor, with mostpancreatic tumors recapitulating one of the nor-mal epithelial cell lines of the pancreas: ductal,acinar, or endocrine. Infiltrating ductal adenocarci-noma is by far the most common type of pancreaticcancer and, therefore, is often used synonymouslywith pancreatic cancer. It is a tumor which recapitu-lates the characteristics of normal pancreatic ductswith tubule or gland formation and mucin produc-tion.

There is a growing body of evidence to support pancreatic intraepithelial neoplasia (PanIN) as the precursor lesion to infiltrating ductal adenocarcinoma.Most invasive adenocarcinomas are associated withmicroscopic non-invasive epithelial proliferationswithin smaller pancreatic ducts.

Most cases of pancreatic cancer are sporadic, however,approximately 10% of cases can be familial. While the genetic basis of most familial cases has not be

elucidated; a number of genetic syndromes have beenassociated with an increased risk of pancreatic cancersuch as hereditary breast cancer syndrome (BRCA2 &BRCA1), Familial Atypical Multiple Mole-Melanoma(FAMMM) syndrome, familial pancreatitis, Peutz-Jeghers syndrome, hereditary non polyposis colorectalcancer syndrome (HNPCC) and Fanconi’s anemia.

PATHOLOGIC DIAGNOSIS

Fine needle aspiration (FNA) biopsy is a procedureoften used to sample pancreatic lesions. Diagnosisrequires correlation of the gross, microscopic, clinical,and radiographic features. EUS-guided FNAs havebecome the preferred sampling procedure at manyacademic centers and large community hospitals.Brush cytology or small biopsies obtained duringERCP or CT-guided percutaneous FNAs can also provide material of pathologic diagnosis.

EUS-guided FNAs may contain gastric or duodenalepithelial contamination which is generally not anissue when diagnosing poorly differentiated cancersbut can present a significant challenge with well differentiated tumors. The composition of the cellularelements on the aspirate slides is important for accurate diagnosis. The architectural arrangement ofcarcinoma cells (i.e., sheets, balls, clusters, single cells)and the arrangement of the cells within these group-ings are important diagnostic features. Cytologicallythe nuclei of the cells lining neoplastic glands showmore variability in the size and shape and intracellularlocation when compared to benign glands. A four-fold variation in nuclear size within a gland is virtuallydiagnostic of carcinoma.

There are two common types of surgical resections ofthe pancreas from which a pathologist receives tissue: a pancreaticoduodenectomy (Whipple specimen) or a

Patricia Belair, MDATTENDING PHYSICIAN, PATHOLOGY

MAPLEWOOD PATHOLOGY, PC

Patricia Belair, MD

Malignant glands from an EUS-guided FNAcytology smear


distal pancreatomy. Intraoperative frozen sections areoften used to evaluate surgical margins or to confirm ametastasis.

Grossly, most ductal adenocarcinomas are poorlydefined, firm, solid, infiltrative masses. Some tumorsmay form cysts. The majority arise in the pancreatichead. In some cases, there may be a pre-existing intra-ductal cystic neoplasm associated with an invasive ductaladenocarcinoma.

Microscopically, conventional invasive ductal adenocarci-noma is comprised of mucin-producing, gland-formingepithelial cells within abundant desmoplastic stroma.Well differentiated ductal adenocarcinomas have welldefined glands with cuboidal to columnar cells withbasal nuclei. Mild nuclear pleomorphism and fewmitoses are present in well defined adenocarcinomas. Inmoderately differentiated adenocarcinomas, the glandsare less well formed with frequent incomplete lumina.There is more prominent nuclear pleomorphism andmitotic activity. Poorly differentiated adenocarcinomashave more poorly formed glands, with individual infiltrating cells or solid groups of cells.

A pathologist uses multiple features to establish a diagnosis of pancreatic carcinoma. The most difficultdifferential diagnosis is the distinction between well differentiated adenocarcinoma, from benign ductules inchronic pancreatitis. Non-neoplastic ducts maintain the normal lobular architecture of the pancreas whilemalignant glands have a haphazard pattern of infiltra-tion. Another important feature is finding neoplasticglands where they should not be. The invasive carcinomaglands may be found adjacent to muscular blood vesselswithout intervening acinar tissue, a feature not seen inthe normal pancreas, or may invade nerves, lymphaticsand blood vessels.

Variants of adenocarcinoma include adenosquamous carcinoma, colloid carcinoma, hepatoid carcinoma,medullary carcinoma, undifferentiated carcinoma andundifferentiated carcinoma with osteoclast-like giantcells.

The majority of pancreatic adenocarcinomas elicit anintense desmoplastic stromal response accounting for the firm consistency of most tumors. Many infiltratingductal adenocarcinomas obstruct the main pancreaticduct causing chronic pancreatitis and atrophy of theparenchyma upstream from the main tumor mass.Pancreatic adenocarcinomas are extraordinarily invasivetumors. They typically invade widely through the

connective tissue stroma of the pancreas and oftenextend into peripancreatic adipose tissue. Neoplastic cellsoften grow along or within the ductal system and nervesextending beyond the main tumor. Perineural invasion isseen in over 75% of pancreatic cancers. Invasive pancre-atic adenocarcinomas also frequently invade lymphaticsand blood vessels. Lymph node metastases are often present.

Pathology is essential for the evaluation and treatment ofpancreatic cancer. Initial cytologic and/or surgical biopsyspecimens provide confirmation of a clinical diagnosisand further characterize the pancreatic neoplasm.Microscopic examination of surgically resected tissuesprovides further information on the pathologic extent ofthe tumor for use in cancer staging systems to determineprognosis and best treatments options. �

Cut surface of pancreas with ductal adenocarcinoma

Pancreatic ductal adenocarcinoma


Anatomic Stage/Prognostic Group

Stage 0 Tis N0 M0 Carcinoma in situ

Stage IA T1 N0 M0 Tumor limited to pancreas, 2 cm or less

Stage IB T2 N0 M0 Tumor limited to pancreas, more than 2 cm

Stage IIA T3 N0 M0 Tumor extends beyond pancreas but withoutinvolvement of celiac axis or superior

mesenteric artery

Stage IIB T1 N1 M0 Regional node metastasis

T2 N1 M0

T3 N1 M0

Stage III T4 Any N M0 Tumor involves celiac axis or superiormesenteric artery

Stage IV Any T Any N M1 Distant metastasis

REFERENCES

Centano BA. Diagnostic cytology of the biliary tract and pancreas. In Surgical Pathology ofthe GI Tract, Liver, Biliary Tract and Pancreas, 2nd ed. Philadelphia, PA Saunders Elsevier,2009

Hruban RH and Fukushima N. Pancreatic adenocarcinoma: update on the surgical pathologyof carcinomas of ductal origin and PanINs. Mod Pathol 2007:20, S61-S70.

Hruban RA, Pitman MB, and Klimstra DS. AFIP Atlas of Tumor Pathology Series 4 Tumors ofthe Pancreas. The American Registry of Pathology, Washington, DC. 2007

Klimstra DS and Adsay NV. Tumors of the pancreas and ampulla of Vater. In SurgicalPathology of the GI Tract, Liver, Biliary Tract and Pancreas, 2nd ed. Philadelphia, PA SaundersElsevier, 2009


HISTORICAL ROLE OF RADIATION THERAPYOncologists in the U.S. have long pointed to the GastrointestinalTumor Study Group (GITSG) study published in 1985 showing survival benefit for chemotherapy and radiation therapy in patientswith pancreatic cancer who received curative resection.1 This was avery small study with only 43 patients randomized. There has beenfurther criticism of the study as the protocol adherence was low andthe dose of radiation therapy (4000 cGY given over a six-week periodwith a two-week planned break) is perceived to be low by modernstandards. The beneficial results were attempted to be replicated inlarger studies. A large European trial headed by the EuropeanOrganisation for Research and Treatment of Cancer, EORTC,enrolled 218 patients.2 There was not a statistically significant differ-ence in outcome between the groups, refuting the GITSG findings.

Meta analyses are statistical tools that allow for pooling of data andprovide insight into outcomes for treatment modalities. A meta analysis of randomized adjuvant therapy trials for pancreatic cancerindicated that postoperative chemotherapy improved survival, whilethe combination of chemotherapy and radiation therapy did not.3

Despite the equivocal results regarding the benefits of postoperativeradiation therapy, most American oncologists have a prejudice to relying on the GITSG data, although it has been 25 years since itspublication, and recommend postoperative treatment.

Since local regional control can be problematic in pancreatic cancer,the use of preoperative therapy is being explored to see if this canimprove outcomes. Preoperative therapy has shown beneficial resultsin other sites of the gastrointestinal tract notably for advanced rectalcancer. Potential concerns for increased perioperative complicationswith preoperative treatment are not borne out in the literature.

Clinical Trials andPancreatic Cancer

Duncan Savage, MDATTENDING PHYSICIAN

ALBANY RADIATION ONCOLOGY ASSOCIATES

Duncan Savage, MDINTRODUCTION

The survival rate for those afflictedwith pancreatic cancer is very slim.Analysis of the National CancerData Base published in 1999shows no improvement in survivalfor patients diagnosed with pan-creatic cancer over the preceding20 years. Most patients are diagnosedwhen curative surgery is technically notpossible. Moreover, for those patientswho are able to undergo a curative resection, the five-year survival hoversaround 20%. Clearly, these dismal survival rates highlight the need fordevelopment of innovative approachesto ameliorate survival.


Preoperative treatment, with either chemotherapy aloneor chemotherapy combined with radiation therapy, offersthe possibility of reducing tumor bulk prior to surgery,thereby making resection easier. This preoperative treat-ment with chemotherapy alone is being piloted in thecurrent St. Peter’s Hospital American College ofSurgeons Oncology Group (ACOSOG) trial, which isdescribed in further detail below.

CURRENT PANCREATIC CANCER CLINICAL TRIALSThe National Cancer Institute’s website lists 28 clinicaltrials that are currently enrolling patients with pancreaticcancer. The multitude of available studies attests to thelack of standard treatment approaches that offer a goodchance of cure. Most of the studies are exploring uses ofnovel chemotherapy agents and combinations prior tosurgery to allow for greater chances of successful surgicalresection. Proton therapy, which targets the tumor andminimizes the dose of radiation therapy to healthy adjacent tissues is also being investigated. As noted previously, successful surgical resection appears to be thefactor that is associated with long-term survival.

ERLOTINIB USE FOR TREATING PANCREATICCANCER

Epidermal growth factor receptor (EGFR) inhibitorshave shown promise in the treatment of certain cancerswhen used in combination with chemotherapeuticagents. EGFR inhibitors work by attaching themselves tocancer cells and obliterating them.4 In November of2005, the FDA approved the use of erlotinib, an EGFRinhibitor, for first line treatment of pancreatic cancerwhen administered with gemcitabine.5 Erlotinib is anoral medication that is taken daily for a prescribed dura-tion of time. Erlotinib, when used in combination withgemcitabine, has been shown to improve overall and one-year survival. (SEE TABLE 1).6 Several studies havebeen and are currently being conducted to further inves-tigate erlotinib and its effect on pancreatic cancer. At the2010 American Society of Clinical Oncologists (ASCO)meeting, data was presented for several studies involvingthe use of erlotinib with gemcitabine as compared withgemcitabine alone.6

Further investigation exploring the benefits of usinggemcitabine and erlotinib for treatment of pancreaticcancer is obviously necessary, however the data analyzedthus far shows promise in the effective treatment of pancreatic cancer while utilizing this therapeutic combination.

ST. PETER’S CANCER CARE CENTER CLINICAL

RESEARCH PROGRAM

In the summer of 2009, the St. Peter’s Cancer CareCenter Research Program was established. The missionof the Research Program is to actively contribute to theSt. Peter’s Health Care Services mission to provide com-prehensive health services by developing and implement-ing a solid, current, and innovative clinical researchdepartment in order to offer our patients the opportuni-ty to seek care through clinical trials. We will ensure thatany research we participate in fulfills a scientific purposeand that the desired result has scientific value. We arecurrently a member of the American College of SurgeonsOncology Group (ACOSOG) and the RadiationTherapy Oncology Group (RTOG). These cooperativegroups are funded through various endeavors includingthe National Cancer Institute (NCI), a subset of theNational Institute of Health (NIH), which is the ulti-mate governing body for cancer related research asidefrom the FDA. Membership with ACOSOG and RTOGallows us to participate in clinical trials through an established network of research centers and research professionals. We are currently participating in anACOSOG clinical trial, and broadening our horizons byseeking out other clinical trials in several disciplines.

CLINICAL RESEARCH PROGRAM DEVELOPMENT

Design and implementation of a research programrequires multi-step processes that conform to nationallyrecognized standards. Historically, there were no standards for conducting human research. This allowedfor the exploitation of human subjects and subsequentlydemonstrated a need for ethical standards. The core ofethical standards includes the following main compo-nents: The Nuremberg Code, The Declaration ofHelsinki, The Belmont Report, sections 21 and 45 ofthe Code of Federal Regulations (CFR), and theInternational Conference on Harmonisation (ICH).7

Each component has a specific purpose and in combina-tion, they provide protection for human subjects whochoose to participate in research. In addition to con-forming to these ethical standards, each research protocolthat is developed must have a sound scientific purpose,be beneficial to society, be free of commercial interestand also free from investigator bias. The risks for human

Variable Gemcitabine Gemcitabine & Erlotinib

Overall Survival 5.9 months 6.2 months

1-year Survival 17% 23%

Table 1


subjects should be minimized and must be outweighedby the benefits to the research. Each protocol must bereviewed and approved by an Institutional Review Board(IRB) prior to subject enrollment. The IRB at St. Peter’sHospital includes members from various backgrounds,both scientific and non-scientific. The IRB has a respon-sibility to ensure the safety and ethical treatment of allhuman research subjects. IRB members review the proto-col and any additional components, such as advertisingmaterials targeted toward human subject recruitment. If the IRB approves the protocol, then a study can beofficially opened, subject recruitment can commence,and patient enrollment will ensue. At any point duringthe clinical trial, the subject may withdraw from the trialwithout penalty. Data is collected throughout the courseof the trial and is reported to the IRB at certain timepoints throughout the duration of the trial. The IRB hasthe ability and responsibility to suspend a clinical trial ifthere is evidence of unethical treatment of human sub-jects and/or violation of the protocol. Periodic data sub-mission and any protocol deviations are also required bythe protocol sponsor.

CURRENT PANCREATIC CLINICAL TRIALS AT


Currently at St. Peter’s Cancer Care Center, we have oneclinical trial open, the ACOSOG Z5041 Trial: A PhaseII Study of Preoperative Gemcitabine and Erlotinib PlusPancreatectomy and Postoperative Gemcitabine andErlotinib for Patients with Operable PancreaticAdenocarcinoma. The Principal Investigators are Dr. Arthur Sunkin, Medical Oncologist, and Dr. JasonHeckman, Hepatobiliary Surgeon. Patients receive sixtreatments of gemcitabine and 43 days of erlotinib, followed by surgery, and then six treatments of gemcitabine and 43 days of erlotinib. Each patient is then followed for up to four years, to determine progression free survival. The purpose of the study is todetermine the percent of patients still living after twoyears of study enrollment. In addition, data will be analyzed to determine the effect of preoperative therapyon disease progression and resection rate. This clinicaltrial is currently open for enrollment and we currentlyhave patients enrolled in this trial. �

REFERENCES

1. Kalser, M.H., Ellenberg, S.S. Pancreatic Cancer. AdjuvantCombined Radiation and Chemotherapy Following CurativeResection. Arch Surg. 1985, 120 (8): 899-903.

2. Klinkenbijl, JH., Jeekel, J., Sahmoud, T., van Pel, R., Couvreaur,M.L., Veenhof, C.H. Adjuvant radiotherapy and 5-fluorouracilafter curative resection of cancer of the pancreas and peri-ampullary region: phase III trial of the EORTC gastrointestinaltract cancer cooperative group. Annals Surgery 1999; 230 (6):776.

3. Stocken, D.D., Buchler, M.W., Dervenis, C., Bassi, C., Jeekel, H.,Klinkenbijl, J.H., Bakkevold, K.E., Takada, T., Amano, H.,Neoptolemos, J.P. Meta-analysis of randomised adjuvant therapytrials for pancreatic cancer. British Journal of Cancer 2005; 92:1372-81.

4. http://www.mayoclinic.com/health/egfr/AN02005

5. http://www.cancer.gov/cancertopics/druginfo/fda-erlotinib-hydrochloride

6. Merl, Y.M., Abdelghany, O., Li, J., Saif, M.W. First-Line Treatmentof Metastatic Pancreatic Adenocarcinoma: Can We Do Better?J Pancreas (Online) 2010 Jul 5; 11(4):317-320.

7. Perlman, D. Ethics in Clinical Research: A History of HumanSubject Protections and Practical Implementation of EthicalStandards. SoCRA Source (Online) 2004 May; 37-41.


PANCREATIC CANCER

Pancreatic cancer has no early warning signs. As a result, pancreatic cancer is usually discoveredwhen the disease has spread to other organs(metastasized). The National Cancer Institute estimates that in the United States this year there will be 43,140 new cases of pancreatic cancer and 36,800people will die from the disease. In the United States,cancer of the pancreas is the fourth leading cause of cancer deaths in both men and women. Hopefully, withbetter diagnostic tests and newer treatments emergingfor this disease, these statistics will change and peoplediagnosed with pancreatic cancer will have a more optimistic future.

KEY RISK FACTORS

• Diet – a diet high in cholesterol, fried foods andprocessed meats, such as bacon and sausage, mayincrease the risk of pancreatic cancer.

• Obesity – people who are significantly overweightare 20 times more likely to develop pancreatic cancer.

• Smoking – people who smoke increase theirchances of developing pancreatic cancer two tothree- fold over non-smokers.

• Age – almost all patients with pancreatic cancer are over the age of 55. As people age, their risk ofpancreatic cancer increases. Pancreatic cancer canalso occur in younger people who have a familyhistory of the disease.

• Family History – first-degree relatives (parent, sibling or child) of patients with pancreatic cancerhave an increased risk of developing it.

• Medical Factors – some medical conditions arepresent in patients with pancreatic cancer such asdiabetes and chronic pancreatitis, however, it isunknown whether these are risk factors or presentas a result of the cancer itself.

• Hereditary Syndromes – certain hereditary syn-dromes may be associated with the development ofpancreatic cancer. If you have any of the followingsyndromes, you should discuss early screening withyour doctor: Familial Breast Cancer Syndrome(BRCA2); Familial Atypical Multiple MoleMelanoma (FAMM) Syndrome; Peutz-JeghersSyndrome (PJS); Hereditary Pancreatitis; LynchSyndrome; Werner’s Syndrome.

RISK REDUCTION

The primary prevention for all cancers is to maintain ahealthy weight, quit or abstain from smoking, exerciseregularly, eat a diet rich in fruits and vegetables, andavoid fried and cholesterol laden foods, and processedmeats.

If you have a family history, any of the medical conditions and/or hereditary syndromes listed above,you should discuss early screening with your primarycare physician.

SIGNS AND SYMPTOMS

Pancreatic cancer is often called “the silent disease” assigns or symptoms remain unnoticed until the cancer isat an advanced stage. When symptoms do occur, theycan include jaundice (yellowing of the skin and eyes),itching, dark urine, light colored stools, fatigue, weak-ness, loss of appetite, abdominal and back pain, nauseaand vomiting, unexplained weight loss, and new onsetdiabetes and/or pancreatitis.

Community Educationand Outreach

Diane Keasbey, RN, OCNCOMMUNITY OUTREACH NURSE

Diane Keasbey, RN


PREVENTION AND SUPPORT

Since there are currently no screening methods to detectpancreatic cancer in the general population, formalscreening programs for those individuals at higher riskfor the disease usually take place at large medical institu-tions. The number of institutions in the United Statesperforming screenings as part of research studies isincreasing and smaller centers are also becominginvolved.

Research into the causes, prevention, detection, andtreatment of pancreatic cancer is ongoing worldwide.New techniques in surgical approaches, radiation therapy, and medical oncology regimens for those diagnosed are improving survival rates, and pancreaticcancer is becoming less deadly than it once was.

As noted above, if you have a family history, any of the medical conditions or hereditary syndromes that predispose you to pancreatic cancer, you should discussearly screening with your primary care physician.

If you or a loved one have pancreatic cancer or you havebeen affected by the disease in any way, you can obtainadditional information from the following sources:

• The Lustgarten Foundation for Pancreatic CancerResearch, 1111 Stewart Avenue, Bethpage, NY11714, www.lustgarten.org, 1-866-789-1000

• Pancreatic Cancer Action Network, 2141Rosecrans Avenue, Suite 7000, El Segundo, CA90245, www.pancan.org, 1-877-272-6226

• The National Pancreas Foundation, 364 BoylstonStreet, 4th Floor, Boston, MA 02116,www.pnacreasfoundation.ogr, 1-866-726-2737

• Pancreatic Cancer Alliance, www.pancreatical-liance.org

• Pancreatica, 149 Bonifacio Place, Monterey, CA93940, www.pancreatica.org, 1-800-525-3777

• National Cancer Institute, www.cancer.gov; 1-800-4-CANCER (422-6237)

• Hirshberg Foundation for Pancreatic CancerResearch, 2990 S. Sepulveda Boulevard, Suite300C, Los Angeles, CA 900064, 310-473-5121,www.pancreatic.org

COMMUNITY EDUCATION AND OUTREACH

St. Peter’s Cancer Care Program maintains a comprehen-sive and dynamic program of support services for indi-viduals with cancer, as well as prevention and early can-cer detection activities for members of the community.Each year, the Cancer Care Program, under the direction of a dedicated, full-time Community Outreach Nurse,provides lectures, offers free cancer screenings, and facilitates support groups. In addition, the CommunityOutreach Nurse represents the center at health fairs,fundraising events, and advocacy activities. TheCommunity Outreach Nurse partners with communityorganizations to sponsor free lectures and screenings,support groups, complimentary therapies, and variousfundraising races and walks, including the AlbanyPancreatic Cancer Research Walk held this year at ElmAvenue Town Park in Delmar.

St. Peter’s Hospital is a part of the New York StateCancer Services Program, which is funded by the NewYork State Department of Health. Through a grant withthe Department of Health, St. Peter’s Hospital supportsthe Albany and Rensselaer County Partnerships whichare coordinated by employees at the American CancerSociety. This program helps identify uninsured andunderinsured women and men who may be eligible forscreening services. Once identified, the program providesfree screenings for breast and cervical cancers to women40 and over and free colorectal screenings for both menand women over the age of 50. Early detection, preven-tion, and education helps to save lives and decrease treatment costs.

The Community Outreach Nurse also facilitates aWomen’s Cancer Support Group which meets the firstMonday of the month. This group provides an opportu-nity for women to discuss their treatments and sideeffects as well as the personal and social issues surround-ing their disease. This group is an open forum and hasan occasional speaker. Additional cancer support groupsare available through Gilda’s Club, To Life, and CapitalRegion Action Against Breast Cancer.

The community outreach nurse has partnered with theCapital District Tobacco-Free Coalition and The Centerfor Smoking Cessation to become a certified smokingcessation counselor and to allow smoking cessation programs to be run at St. Peter’s Hospital. Throughcooperation of these two programs, the outreach nursehas been able to provide prevention education through-out our local communities. �

Advanced treatment options, dedicated professionalsand a unique caring environment make St. Peter’sone of the most well-regarded health systems.

In recent years, St. Peter’s Hospital has been recognizedby national and state health care quality organizationsfor excellence in care. We offer a comprehensive,

integrated continuum of services – ranging from acute carein the hospital to outpatient services, home care, nursing homes,

hospice care, addictions treatment and much more.

St. Peter’s continues to set the pace for health care innovations.We are 4,500 professionals who knowthat technology is critical to treatment,but compassion is the key to healing.

The science of medicine.The compassion to heal.

317 South Manning Boulevard • Albany, New York 12208 • 518-525-1662www.sphcs.org

ST.P ETER S CANCER CARE CENTER 2010A NNUAL REPORT€¦ · had just heartburn or indigestion,”...

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