Innovations in Pancreatic Cancer: A Reason to Hope
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Transcript of Innovations in Pancreatic Cancer: A Reason to Hope
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Innovations in Pancreatic Cancer:Reason to Hope
A. James Moser, M.D. FACS.Director, Institute for Hepatobiliary and Pancreatic Surgery
Beth Israel Deaconess Medical Center
Visiting Associate Professor of Surgery
Harvard Medical School
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We Share Your Mission
• Imagine a Future without Pancreatic Cancer!– Raise Awareness Today
• Early diagnosis and prevention– Hope for Tomorrow
• Dedicated team of cancer specialists• “Living” with pancreatic cancer
– Change in the FUTURE• Clinical trials• Outreach and Fundraising for a “cure”• Laboratory research
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Focus on the Imminent:Modern Total Pancreatectomy
• 62 yo man; recurring abdominal pain• chronic pancreatitis; PRSS1 gene mutation• Predicted 25% lifetime risk of PDA• PanIN3; Back at work three weeks postop
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Rising Incidence of Pancreatic Cancer
• Geographic risk of pancreatic cancer – Rising in Cape Cod and
New England– Falling in Western PA and
West Virginia• Aging population• Obesity• Genetic risk factors• Smoking
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• By 2030:– 2nd cause of cancer death– 1.4-1.8% incr. per year
• Possible Factors– Obesity– Caucasian
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Pancreatic Cancer Statistics
• 4th most common cause of cancer death– 34,000 new cases every year – “Silent” disease
• Vague abdominal pain or unexplained weight loss• New-onset diabetes (one in 332 new patients)• Smoking (two-fold increased risk)• Family history of cancer (two-fold in 1st degree relatives)
• When the tumor is found:– 15% of patients have operable cancer (stage 1/2)– 25-30% have advanced pancreatic cancer (stage 3)– 55% cancer has spread (metastatic, stage 4)
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Extent of Disease at Diagnosis
Shaib et al, Aliment Pharmacol Ther 24, 87-94, 2006
Improvements in diagnostic imaging?
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Issues for the Pancreatic Cancer Patient
• Can you treat my cancer?• Can you relieve my symptoms?
– Nutrition: Fatigue/ loss of appetite– Pain– Jaundice: Bile duct blocked– Nausea and vomiting
• Narrowing of outlet from stomach• “No one to watch over me”
– Physician specialization– Regionalization of care
• The Internet has no librarian
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No Librarian=Confusion
Sener et al, J Am Coll Surg 1999; 189: 1-7.
National Cancer Database Statistics on 100,313 Patients 1985-1995
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“Why do you need to go to medical school when you have the Internet?”
• PubMed citations for pancreatic cancer:– 2592 clinical trial reports
• 1530 chemotherapy trials• 1134 surgery citations• 165 chemoradiation trials
• “Don’t be afraid to see what you see.”
Ronald Reagan
His Expectation
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Regionalized Care for Pancreatic Cancer?
Sener et al, J Am Coll Surg 1999; 189: 1-7.
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BIDMC Pancreatic Cancer CenterVision
The state of the art for pancreatic cancer is a
clinical trial.
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Internet Resources
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Evolution of Personalized Medicine
• 19th century– “The practice of medicine is an art…” William Osler
• 20th century– RCTs to delineate outcome variables
• NSABP ‘s triumph over radical mastectomy
• 21st century: art replaced by science– The tumor target: the 6th vital sign– Oncotype DX
• Stage I/II node negative ER(+) breast cancer• Recurrence risk based on gene expression profiling
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The Future of Pancreatic Cancer
• Combine new treatments to– Kill cancer cells around the main tumor
and in the liver– Optimize patient selection for surgery– Maximize survival
• Maximize quality of life after surgery• Immunotherapy• Novel Chemotherapy after surgery
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BIDMC Pancreatic CancerSpecialty Care Center
617-667-PANC (7262)
• Multidisciplinary Clinical Care – Specialized expertise
• Pancreatic surgery• Gastroenterology• Medical oncology• Radiation oncology• Chronic pain• Cancer genetics • Nutrition/ Alternative
Medicine Social Work
• Clinical Research – Pancreatic Cancer Registry
• Database– Clinical Trials
• New drugs• Immunotherapy• Cyberknife• New stents• Molecular diagnosis
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Staging, Diagnosis, and Treatment
• Stage the disease– Stage I/II: surgery is possible– Stage III: too advanced for surgery– Stage IV: metastatic
• Stage-specific therapy– Stage I/II: surgery, systemic therapy, radiation– Stage III: systemic therapy, radiation, ?surgery– Stage IV: systemic therapy
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Allaying Fear of Chemotherapy
• Stage 4; Gemzar/Xeloda• How will chemo make me feel?
• Less burden with time• Reduced coping effort
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Better Quality of Life
• Stage 4 pancreatic cancer• Gemzar/Xeloda
– Reduced pain– Improved mood
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Chemotherapy That Works
• FOLFIRINOX vs. Gemcitabine (2011)– Stage 4 pancreatic cancer– Significantly improved:
• response rate• disease control (63%-79% of patients)• Better quality of life at 6 months
– 75% improvement in overall survival
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Stereotactic Radiosurgery (Cyberknife)
• Highly-conformal XRT with real-time imaging
• Gold fiducials for targeting• Breath-tracker software• 36 Gy, 3 fractions• Multiple studies
– All pts had local control– Distant mets as first site
of progression
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Whipple’s Operation:Localized Pancreatic Cancer
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Leave No Cancer Behind
Portal vein NOT involved Portal vein involved
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No Substitute for Experience
Makary et al, Pancreaticoduodenectomy in the very elderly, JOGS 2006.
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Case Presentation:
• 70 y/o woman with painless jaundice• CT showed 2x3 cm ill defined mass in head
of pancreas • EUS confirms mass• Biopsy revealed adenocarcinoma• ERCP showed obstruction of bile duct• Surgery first vs. clinical trial
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Endoscopic Ultrasound
• Hypoechoic lesion in pancreatic head
• Intact hyperechoic interface between tumor and PV
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Case Presentation
• Robot-assisted minimally-invasive pancreaticoduodenectomy (Whipple operation)
• Uneventful recovery discharged home on POD 10 eating a regular diet.
• Final pathology revealed 2 cm adenocarcinoma, negative margins and no lymph node involvement
• Received adjuvant chemotherapy on a clinical trial
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Advanced Pancreatic Cancer
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Worse Cancer = Even Bigger Operation
Portal vein involved
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Preoperative Therapy for PAC
• Goals of neoadjuvant multimodality therapy:– reduce risk of positive margin– Sterilize regional lymph nodes– Treat systemic disease
• Candidates for neoadjuvant therapy– Resectable (new indication)– Locally-advanced disease
• invasion of SM-PV confluence, mesenteric arteries• local lymphadenopathy
• Published: 5-FU, gemcitabine, paclitaxel, + XRT
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BIDMC Pancreatic Cancer Center Mission
• Combine new treatments to:– Improve survival – Optimize patient selection for surgery
• Chemotherapy and radiation before surgery– Surgical patients with “resectable” pancreatic cancer
– Reduce recurrences in the liver– Chemotherapy/Cyberknife for advanced cancers
• Novel radiotherapy: Stereotactic radiosurgery• Immunotherapy and new agents for metastatic disease
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Does Radical Surgery Improve Outcome?
• “Regional” pancreatectomy to clear SMA margin – increased morbidity and mortality (Fortner) – No patients with positive margins survive 5 years
• Extended lymphadenectomy does NOT improve survival
• EQUIVALENT results after portal vein resection• tumor interface with PV/SMV• Location, not biology?
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What We Do
• Multidisciplinary evaluation by expert team• BIDMC Pancreatic Cancer Specialty Care Center– Multidisciplinary Pancreatic Cancer Conference
• Helical pancreas mass protocol CT • Endoscopic Ultrasound (EUS)• Encourage neoadjuvant therapy on protocol • Staging laparoscopy
– Inspect peritoneal surfaces; UTZ for suspicious hepatic lesions
• Portal vein resection: Yes • En bloc resection of adjacent organs: Probably• Adjuvant chemotherapy: Yes
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Staging, Diagnosis, and Treatment
• Stage the disease– Stage I/II: surgery is possible (resectable)
• Tumor diameter• Presence of lymph nodes
– Stage III: too advanced for surgery • Mesenteric vascular involvement• “Borderline” resectable vs. locally-advanced
– Stage IV: metastatic• Stage-specific therapy
– Stage I/II: surgery, systemic therapy, ?radiation
– Stage III: systemic therapy, radiation, ?surgery
– Stage IV: systemic therapy
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Lessons from Radical Surgery
• Locally and regionally aggressive disease at diagnosis• Resection improves survival in a subset of patients
– No validated models to determine who will/will not benefit
– nodal, retroperitoneal margin status and PV invasion difficult to evaluate with certainty
• Time to focus on tumor biology, not location– sterilize locoregional nodes and peripancreatic
tissue
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Evolution of Personalized Medicine
• 19th century– “The practice of medicine is an art…” William Osler
• 20th century– RCTs to delineate outcome variables
• NSABP ‘s triumph over radical mastectomy
• 21st century: art replaced by science– The tumor target: the 6th vital sign– Oncotype DX
• Stage I/II node negative ER(+) breast cancer• Recurrence risk based on gene expression profiling
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Personalized Medicine for PAC
• Continuous quality improvement– Minimizing perioperative morbidity– Maximize adjuvant therapy
• Individualize surgical decision-making– Beyond the “one-size-fits-all” approach– Genetic predictors of aggressive biology
• Tumor genetics accessible preoperatively– Identifying responders prior to surgery
• Rational target selection for chemotherapy– Tailor the treatment to the tumor
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Neoadjuvant Design Elements
• Analysis of treated tumor – Science leads the way
• Potential clinical benefits– reduce risk of positive margin– Sterilize regional lymph nodes– Early treatment of systemic disease
• Candidates for neoadjuvant therapy– Resectable (new indication)– Locally-advanced disease
• invasion of SM-PV confluence, mesenteric arteries• local lymphadenopathy (Stage 2B)
• Published: gemcitabine, cisplation, paclitaxel, etc
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Molecular Profiling
• Rational target selection for chemotherapy– Gene expression profiling and immunohistochemistry
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Bilimoria K, National Failure to Operate on Early Stage Pancreatic Cancer, Ann Surg 2007 Aug
Perception Trumps Reality
!
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Why Minimally-Invasive Surgery?• Potential benefits
– Improved quality of life– Increased patient acceptance– Earlier/more frequent adjuvant chemotherapy– Better cancer outcomes?
• Foreseeable risks– Oncologic compromises
• Margin negative rate/ nodal harvest– Preventable technical harm
• Conversion events
• Fear of Cost differential
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Minimally-Invasive Pancreatic Surgery
• World’s largest experience: 250 cases to date• Tumors in the pancreatic neck, body, tail
– Benign and malignant lesions– Distal and extended distal pancreatectomy
• With/without splenectomy– Enucleation for islet cell tumors
• Pancreatic head lesions– Enucleation– Robotic pancreatoduodenectomy (Whipple)
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This is the Future…But Not Yet
Fancy molecular stuff
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Minimally-Invasive Pancreatic Oncology
1. Recreate open techniques
2. Maximize margin negative outcomes
3. Minimize conversions
4. Eliminate selection bias
Validated prediction ruleBao et al, HPB 2009
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Bilimoria K, National Failure to Operate on Early Stage Pancreatic Cancer, Ann Surg 2007 Aug
Perception Trumps Reality
!
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This is the Future…But Not Yet
Fancy molecular stuff
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Minimally-Invasive Pancreatic Oncology
1. Recreate open techniques
2. Maximize margin negative outcomes
3. Minimize conversions
4. Eliminate selection bias
Validated prediction ruleBao et al, HPB 2009
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Minimally-Invasive Surgery for PDC
• Retrospective, 9 centers, 2000-2008– 212 distal panc for PDC, 23 laparoscopic– 3:1 matched comparison to historical controls– Minimally-invasive patients heavier
• Pathology– No differences in margin status or nodal harvest
• Minimally-invasive group– Reduced hospitalization (2 days)– Reduced blood loss
Kooby et al J Am Coll Surg 2010; 210(5)
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Minimally-Invasive vs. Open• Retrospective, UPMC, 2002-2010
– 62 distal pancreatectomies for PDC (34 open, 28 MIS)– Intention to treat methodology/Propensity score analysis
• Control imbalances between the groups– No selection bias evident
• Demographics, comorbid conditions, imaging factors
• Short-term outcomes: reduced EBL and LOS– 5 laparoscopic conversions to ODP– Complication rates same– Cancer outcomes identical
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Data presented as either mean ± SD, median (IQR), or n (%)
• Robotic procedure superior– Greater risk of PDC in robot group (43% vs. 19%)– No robotic conversions to open surgery
• 0% robotic vs. 16% laparoscopic, p<0.05– Retrieved more lymph nodes (19 vs. 9, p<0.05)– Reduced risk of a positive surgical margin
• 0% robotic vs. 36% laparoscopic (p<0.05)
• Effect of conversion on outcome– Incision; longer hospitalization (2 days); blood loss
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Robotic Pancreatoduodenectomy
• Two experienced surgeons• Surgeon console
– Stereoscopic vision– Fine motor and foot control– Tremor dampening
• Patient console– Three articulated arms– Camera
• Seven laparoscopic ports
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Robotic Dissection and Suturing
split_screen.wmv
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Technical Feasibility
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Outcomes of 100 Robotic-Assisted PD
Characteristic Mean/ Frequency
Age, year, mean ± SD 67.7±12.7Female sex, n (%) 47 (47%)Body mass index, mean ± SD 27.3± 5.7CCI Age Unadjusted 1 (1-3) (Median/ IQR)
CCI Age Adjusted 4 (2-5) (Median/ IQR)
Prior abdominal surgery, n (%) 51 (51%)ASA score, n (%) I 0(0%) II 33 (33%) III 62 (62%) IV 5 (5%)Pre-op CA 19-9 40.7 (16-225)
(Median/IQR)
ASA American Society of Anesthesiologists
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Indications
Lesion n, (%)Pancreatic ductal adenocarcinoma (PDA) 36 (36%)
Peri -ampullary carcinoma ( AC, DCC,Duodenal) 28(28%)
Pre- malignant ( IPMN, adenoma, SCA,MCN) 23 (22%)
Neuroendocrine tumor (NET) 10 (10%) PPN (n=2), MRCC (n=1) 3 (4%)
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100 Robot-Assisted Pancreatoduodenectomies
100p
90P 80p 70p 60p 50p 40p 30p 20p 10p200
300
400
500
600
Min
utes 7 hours