modern medical management of pancreatic cancer€¦ · modern medical management of pancreatic...
TRANSCRIPT
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Modern medical management of
Pancreatic cancer
Harmesh Naik, MD.
Hope Cancer Clinic
CME presentation on January 8, 2014.
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Objectives
• Discuss modern medical management of pancreatic cancer
• Discuss role of multi-disciplinary participation in treatment
• Present examples of actual cases treated using these strategies
• Answer audience questions
• Poll audience responses during interactive session
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Disclosures
• I have been asked by CME office to present this lecture today
• I have not received any financial payments for this lecture
• I have prepared all slides myself
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Scope of discussion
• Discussion in this lecture is limited to exocrine pancreatic cancer-adenocarcinoma unless specified otherwise.
• Endocrine tumors of pancreatic origin have better prognosis and are treated differently.
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General
• Very aggressive cancer
• Highly lethal cancer
• Overall 5 year survival is around 1%
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Incidence
• 2013 SEER estimates
▫ Estimated cases 45,220
▫ Estimated deaths 38,460
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Risk factors
• Mostly unknown
• Possible link to tobacco – smoking – a consistent risk factor
• Chronic pancreatitis may be a risk factor
• Fruits and vegetable rich diet may reduce risk
• Increasing age is a risk factor
• Familial syndromes with increased risk for pancreatic cancer – only a very small number of cases – next slide
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Familial syndromes with increased risk
• Familial breast cancer (Selective genetic mutations BRCA 2 more strongly associated than BRCA 1)
• Familiar pancreatitis syndrome (cationic trypsinogen gene) – pancreatitis
• HNPCC-Hereditary non polyposis colon cancer (DNA mismatch repair gene mutations ) – colon cancer, endometrial cancer
• Familial atypical multiple mole melanoma (p16 mutations – chromosome 9P) – Multiple nevi, atypical nevi and melanoma
• Ataxia telangectasia
• Peutz Jeghers syndrome (STK 11 / LKB 1 mutations) – hamartomatous GI polyps and pigmented skin macules.
• Only 10-20% are thought to have familial pre disposition
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?? Risk factors
• Conflicting data about coffee and alcohol
• Diabetes may be an early manifestation rather than predisposing factor
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Pathogenesis
• KRAS oncogene mutations are common
• Intra ductal proliferative epithelial lesions (PanINs – pancreatic intra-epithelial neoplasms) are considered precursors of invasive ductal pancreatic cancer
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Screening
• No screening is available
• CA 19-9 is not useful for screening
• Optimal screening strategy for patients with strong family history of pancreatic cancer is not known.
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Prevention
• Minimize known risk factors
• No specific prevention strategy is known
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AJCC staging
From cancer.gov
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AJCC staging
From cancer.gov
Beyond pancreas but not in celiac plexus or
SMA
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AJCC staging
From cancer.gov
Positive nodes
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AJCC staging
From cancer.gov
Unresectable: SMA or celiac plexus
involvement
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AJCC staging
From cancer.gov
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AJCC staging
• See AJCC website or cancer.gov for staging details
• Accurate staging is very important in treatment planning
• Prognosis is dependant on stage
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PROGNOSIS
Stage 5 year survival
I 12%-14%
II 5%-7%
III 3%
IV 1%
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Diagnostic testing to determine stage
• CT scan / Ultrasound / MRI
• ERCP / MRCP
• EUS
• Laparoscopy
• PET scan
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TREATMENT OPTIONS
• First step: evaluate patient for possibility of surgical resection
• The benefits of therapy are modest at best, so clinical trials remains a sensible option.
• Multi-modality therapy is generally necessary for most
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TREATMENT OPTIONS
• For patients with poor performance status, best supportive care is appropriate.
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Treatment summary table:
Stage Treatment Comment
Stage I and II Surgery Post operative adjuvant chemo-RT or Chemo
Stage III Chemo-RT or Chemo Palliative care
Stage IV Chemotherapy Palliative care
Palliative care , pain control, billiary stent etc for all appropriate
patients
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Surgery for resectable tumors
• Surgery is only poetically curative treatment
• Only 20% or fewer patients are candidates for potentially curative surgery.
• Diagnostic procedures listed above help determine resectability of pancreatic cancer
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Surgery for resectable tumors
• Goal of Surgery
▫ R0 resection – resection with clean margins
• Multi-disciplinary evaluation is necessary
• Neo-adjuvant therapy for clearly resectable tumors is not recommended at present time
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Surgery: Eligibility
• No distant metastases
• No involvement of SMV or portal vein
• Clear fatty plane around SMA, hepatic artery and celiac plexus
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Surgery: Eligibility
• Generally tumors more than 4 cm size are rarely resectable less than 10% resectability rate
• Invasion of superior mesenteric artery or major blood vessels unresectable tumor.
• Even when the tumor appears to be resectable, as many as 40% of patients will be found to have small metastases to the peritoneum or liver that were not detected on preoperative imaging studies.
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Surgery: results
• Postoperative mortality rates in patients who undergo pancreaticoduodenectomy (Whipple’s procedure) are influenced by the experience of the surgeon and the treatment center.
• In patients who undergo potentially curative surgery, 5-year survival rates have not exceeded 20% to 24% (generally 5% to 25%).
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Case : A
• 75 year old male in good health
• ECOG PS 1
• Pancreatic adenocarcinoma: S/P Whipple procedure. PT2N0 clinical M0, stage IB.
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Case: A
Diagnosis Surgically resectable
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Case : A
▫ NCCN guidelines recommends following current options: 1. Adjuvant chemotherapy with Gemcitabine or FU
or Capecitabine for six months
2. Adjuvant Chemotherapy chemo-RT chemotherapy (Gemcitabine (or FU) one cycle 6 weeks of RT with FU pump (or Xeloda or Gemcitabine) by 3 cycles of Gemcitabine (or FU) as an example.
3. Clinical trial.
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Case : A: What would you choose for him
1. Adjuvant chemotherapy with Gemcitabine or FU or Capecitabine for six months
2. Adjuvant Chemotherapy chemo-RT chemotherapy (Gemcitabine (or FU) one cycle 6 weeks of RT with FU pump (or Xeloda or Gemcitabine) by 3 cycles of Gemcitabine (or FU) as an example.
3. Clinical trial.
4. No treatment – observation only
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Case : A –
▫ Wait …wait….
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Case : A –
▫ Pre chemo CT chest, Abdomen and pelvis :A vague 0.9 cm low attenuation area in liver, reported to be new since surgery , too small to biopsy
▫ Modified plan:
Chemotherapy followed by repeat CT chemo-RT chemotherapy
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Case : A – post chemo CT prior to chemo-RT
And then a new liver lesion Biopsy was positive- stage 4
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Case : A –
• Now stage 4 disease
• Switch to palliative FOLFIRINOX
• Good response so far
• 14 months post diagnosis
• Taking a break from chemotherapy
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Case : A – Post FOLFIRINOX
Much better Marker trend CA 19-9 – good correlation to disease
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Post operative adjuvant therapy
• Surgery alone is not adequate for most
• Controversial – best option is unclear.
• Goal of adjuvant therapy improve Overall survival.
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Post operative adjuvant therapy
Surgery if resectable
Adjuvant chemotherapy
Adjuvant chemo-RT
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Post operative adjuvant therapy
• A small, randomized trial suggested an improvement in median and long-term survival in patients who received postoperative 5-fluorouracil + radiation. This has long been considered standard of care in USA.
• However, the benefit of postoperative chemo radiation has not been confirmed in subsequent randomized trials.
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Post operative adjuvant therapy
CONKO-1 trial from Germany 3 year survival
• Adjuvant Gemcitabine compared to surgery alone
• Considered European standard.
• 5 year: 21% vs 9%
Surgery
Gem
36%
--
19%
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Post operative adjuvant therapy: (ESPAC)
A recent trial in Europe Median survival 23 months
• Similar median survival between adjuvant Gemcitabine versus FU-LV.
• Either of regimen can be considered.
Gem FU-LV
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Post operative adjuvant therapy
• A US trial (RTOG 9704):
• 3 year follow up: suggested improved outcome in pancreatic head tumors with post operative Gemcitabine FU-RT Gemcitabine versus FU-RT (3 year survival of 31% versus 22%).
• 5 year follow up: with further follow up there appears to be no major survival advantage
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Post operative adjuvant therapy
• NCCN guidelines:
• “No definite standard has been established in the adjuvant treatment … “
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Post operative adjuvant therapy
• No one best option
• Customize management based on individual prognostic factors and comorbid conditions
• Options include
▫ Adjuvant chemotherapy
▫ OR adjuvant chemo-RT
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Unresectable tumors
• For patients with locally advanced but unresectable disease
• Options:
▫ Chemo – radiation
▫ Chemotherapy Chemo – radiation
▫ Palliative chemotherapy
▫ Participation in clinical trial
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Unresectable tumors
• Chemotherapy and radiation for unresectable tumors ▫ FU with RT is considered standard in USA ▫ Newer agents such as Gemcitabine, Capecitabine
and targeted agents are under study ▫ Might be better in patients with uncontrolled pain
since RT may help pain. • Chemotherapy alone for unresectable tumors
▫ Reasonable choice ▫ European trial indicated that Induction chemo-RT
with maintenance Gemcitabine was no better than Gemcitabine alone.
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Unresectable tumors
• No one best option
• Customize management based on individual prognostic factors and comorbid conditions
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Surgery: Borderline resectable
• No distant metastases
• Venous involvement of SMV or portal vein (distortion or narrowing of vein)
• Gastro duodenal artery encasement
• Direct abutment of hepatic artery
• Abutment around SMA no more than 180* circumference
• Refer to surgical literature for latest criteria
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Borderline resectable tumors
• Current trials are focusing on neo-adjuvant therapy attempt at surgical resection
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Neo-adjuvant therapy: Options
Neoadjuvant chemotherapy
Surgery if resectable
Adjuvant chemotherapy
+ RT
No surgery if unresectable
Chemo-RT
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Neo-adjuvant therapy: Options
Neoadjuvant chemotherapy
+ RT
Surgery if resectable
Adjuvant chemotherapy
No surgery if unresectable
Adjuvant chemotherapy
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Neo-adjuvant therapy: Options
Neoadjuvant chemotherapy
Chemo-RT
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Neo-adjuvant therapy
• Some patients may develop metastatic disease during neo-adjuvant therapy prior to any definitive local therapy could be done
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Neo-adjuvant therapy
• No one best option
• Customize management based on individual prognostic factors and comorbid conditions
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Case B
CT
• 74 year old female
• Borderline resectable candidate by EUS criteria
• Possible T3N0M0 clinical - Stage IIA or possibly T4N0-III
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Case B: What would you chose?
1. Surgical resection attempt adjuvant chemotherapy or adjuvant chemo-RT.
2. Neo-adjuvant chemotherapy surgery (if tumor is down staged and becomes resectable) adjuvant therapy.
3. Neo-adjuvant chemotherapy + RT surgery (if tumor is down staged and becomes resectable) adjuvant therapy.
4. Neo-adjuvant chemotherapy definitive chemotherapy + RT (non surgical option).
5. Neo-adjuvant chemotherapy pre-op chemotherapy + RT surgery if resectable.
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Case B: She chose
Neo-adjuvant chemotherapy surgery (if tumor is down staged and becomes resectable) adjuvant therapy.
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Case B:
Update New liver lesion
• Two cycles of Gem-Oxaliplatin
• Too high to biopsy
• Complete 4 cycles
• Re-assess
• Will need liver biopsy
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Chemotherapy for metastatic tumors (stage 4 cancer)
• Therapy is palliative.
• Best option is unclear
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Case C
• 52 year old female
• Stage 4 pancreatic adenocarcinoma
• Biopsy of liver x 2 negative, third one positive
• ECOG PS 0-1
• New onset diabetes mellitus
• Wants aggressive treatment
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Case C
Primary
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Case C
Liver mets Liver mets
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Case C: What would you give her
1. Gemcitabine alone
2. Gemcitabine + Tarceva
3. Gemcitabine + Cisplatin or FU or Xeloda.
4. Gemcitabine + FU or Xeloda.
5. FOLFIRINOX
6. Palliative care alone
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Case C
Treatment given Post treatment
• Started FOLFIRINOX
• Good response
• Doing well 8 months later with major response
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Case C : Tumor marker correlation
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Chemotherapy for metastatic tumors (stage 4 cancer)
• Single agent: First line
▫ Gemcitabine is currently the first-line therapy of choice for patients with metastatic disease and good performance status.
▫ Mild to moderate activity seen with Gemcitabine, FU, Taxanes, Platinum and Irinotecan
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Chemotherapy for metastatic tumors (stage 4 cancer)
• First line ▫ Gemcitabine was superior to FU in randomized
trial (better pain control and improved appetite and weight – Clinical benefit) .
▫ Clinical benefit 24%, response rates less than 10%, 1 year survival 18%.
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Chemotherapy for metastatic tumors (stage 4 cancer)
• Combination regimens: First line
▫ Most of the older trials of combinations have failed to show survival advantage over Gemcitabine alone.
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Chemotherapy for metastatic tumors (stage 4 cancer)
• Recent data: First line ▫ Combination may provide slight benefit in good
performance status patients only.
▫ Combination therapy may not provide any advantage in poor performance status patients.
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Chemotherapy for metastatic tumors (stage 4 cancer)
• Combination regimens: First line
▫ Recent data: Gemcitabine + oral Erlotinib was slightly better
than Gemcitabine alone in Progression free survival and survival
Median survival 6.2 vs. 5.9 months
One year survival 23% versus 17% - statistically significant.
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Chemotherapy for metastatic tumors (stage 4 cancer)
• Combination regimens: First line
▫ Recent data:
Gemcitabine + oral Capecitabine was slightly better than Gemcitabine alone in Progression free survival and survival.
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Chemotherapy for metastatic tumors (stage 4 cancer)
• Combination regimens: First line
▫ Recent data: FOLFIRINOX has shown improved responses
compared to Gemcitabine alone (median overall survival 11.1 vs. 6.8 months).
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Chemotherapy for metastatic tumors (stage 4 cancer)
• Combination regimens: First line
▫ Recent data: Nab-Paclitaxel-Gemcitabine has shown improved
responses compared to Gemcitabine alone (median overall survival 8.5 vs. 6.5 months).
1 year survival: 35% vs 22%
2 year survival: 9% vs 4%
Good PS only: PS over 70%
D. D. Von Hoff et al: N Engl J Med 2013; 369:1691-1703
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Second line
• A recent German trial (CONKO 3) reported benefit of second line FU-LV-Oxaliplatin over FU-LV in patient failing first line Gemcitabine.
• Med survival - (26 weeks versus 13 weeks)
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Summary of chemotherapy for stage 4:
• Gemcitabine alone or Gemcitabine containing combination is considered standard of care.
• Gemcitabine containing combination should be used in good PS patients.
• No one best option
• Customize management based on individual prognostic factors and comorbid conditions
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Treatment summary table:
Stage Treatment Comment
Stage I and II Surgery Post operative adjuvant chemo-RT or Chemo
Stage III Chemo-RT or Chemo Palliative care
Stage IV Chemotherapy Palliative care
Palliative care: Pain control, billiary stent, thrombosis prevention and treatment, depression management, nutritional management
etc for all appropriate patients
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Case D
• 72 year old man
• Very active
• Stage 4 disease – adenocarcinoma
• Wanted aggressive therapy
• Was seen at a major cancer center – not satisfied with options provided
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• Chemotherapy x 2 cycles
• Stabilization and borderline response
Case D
March 2008: Liver mets Stage 4 cancer
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• Chemo-embolization
• Severe chemical hepatitis
• Needed high dose steroids
Case D
October 2008 :Liver mets Chemo-embolization -2008
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• Post Chemo-embolization
• Necrotic cystic area remains
Case D
2010
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• 2010 liver mets outside of chemo-embolized field
Case D
2010
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• Biopsy positive pancreatic mass
Case D
2010
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Case D
September 2013
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Case D
• Has now been treated with multiple chemotherapy regimens
• Remains alive and well after 68 months
• Very active
• Has been off chemotherapy for 8 months with stable disease
• Diagnosis: around April 2008
• Last follow up November 2013
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Extra slides
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Do your see or treat patients with
pancreatic cancer? • Yes
• No
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Did you learn any new information
today? • Yes
• No
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Was information discussed relevant to
your practice? • Yes
• No
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Was information discussed free of any bias ?
• Yes
• No
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Will you change your approach to pancreatic
cancer treatment based on this CME?
• Yes
• No
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Were objectives for this CME met?
• Yes
• No
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Overall rating for today's presentation
• Highly satisfied
• Satisfied
• Neutral
• Unsatisfied
• Highly unsatisfied
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