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Case presented by Dr Schwartz

Case presented by Dr Schwartz. 44 yo woman with 4 mo hx of abdominal pain Imaging = pancreatic mass in body/tail 9/1/10: Distal pancreatectomy = well-circumscribed 6 cm adeno CA with perineural invasion, no nodes, but 4mm liver lesion  mets

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Case presented by Dr Schwartz

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  1. Case presented by Dr Schwartz • 44 yo woman with 4 mo hx of abdominal pain • Imaging = pancreatic mass in body/tail • 9/1/10: Distal pancreatectomy = well-circumscribed 6 cm adeno CA with perineural invasion, no nodes, but 4mm liver lesion  mets • 9/27/10: CA19-9 >6,000 and PET/CT extensive liver involvement  FOLFIRINOX as per ACCORD trial • 3 cycles complete – disease responding and CA19-9 ↓85% • Well tolerated except asymptomatic neutropenia

  2. Randomized Phase III Trial Comparing FOLFIRINOX versus Gemcitabine as First-Line Treatment for Metastatic Pancreatic Adenocarcinoma: Preplanned Interim Analysis Results of the PRODIGE 4/ACCORD 11 Trial Conroy T et al. Proc ASCO 2010;Abstract 4010.

  3. PRODIGE 4/ACCORD 11:Selected Grade 3/4 Adverse Events (AE) FOLFIRINOX regimen is more toxic, but toxicity is manageable Conroy T et al. Proc ASCO 2010;Abstract 4010.

  4. PRODIGE 4/ACCORD 11: Efficacy Median follow-up: 26.6 months FOLFIRINOX recommended as new standard of care for metastatic pancreatic cancer with bilirubin <1.5 ULN and PS 0-1 Conroy T et al. Proc ASCO 2010;Abstract 4010.

  5. Adjuvant chemotherapy with fluorouracil plus folinic acid vs gemcitabine following pancreatic cancer resection: a randomized controlled trial Neoptolemos JP et al. JAMA 2010; 304(10); 1073-81 Refinement of adjuvant therapy for pancreatic cancer O’Reilly EM et al. JAMA 2011; 304(10); 1124-5.

  6. Case presented by Dr Schwartz 44 yo woman with 4 mo hx of abdominal pain Imaging = pancreatic mass in body/tail 9/1/10: Distal pancreatectomy = well-circumscribed 6 cm adeno CA with perineural invasion, no nodes, but 4mm liver lesion  mets 9/27/10: CA19-9 >6,000 and PET/CT extensive liver involvement  FOLFIRINOX as per ACCORD trial 3 cycles complete – disease responding and CA19-9 ↓85% Well tolerated except asymptomatic neutropenia

  7. Efficacy Results from the European Study Group for Pancreatic Cancer (ESPAC) 1 and 3 Trials ‡ Median follow-up: 47 months Median follow-up: 34 months Neoptolemos JP et al. N Engl J Med 2004;350:1200-10; Neoptolemos JP et al. JAMA 2010;304(10):1073-81.

  8. Case presented by Dr Schwartz 44 yo woman with 4 mo hx of abdominal pain Imaging = pancreatic mass in body/tail 9/1/10: Distal pancreatectomy = well-circumscribed 6 cm adeno CA with perineural invasion, no nodes, but 4mm liver lesion  mets 9/27/10: CA19-9 >6,000 and PET/CT extensive liver involvement  FOLFIRINOX as per ACCORD trial 3 cycles complete – disease responding and CA19-9 ↓85% Well tolerated except asymptomatic neutropenia

  9. Results of a Phase 1/2 Study of Nab-Paclitaxel Plus Gemcitabine in Patients with Advanced Pancreatic Cancer with SPARC and CA19-9 Correlatives Ramanathan R et al. Proc ESMO 2010;Abstract 743P.

  10. Efficacy of Nab Paclitaxel + Gemcitabine for Advanced Pancreatic Cancer • All evaluable patients had >20% decrease in CA19-9 levels • Survival collated with SPARC signature (13.6 versus 8.1 months in low vs high risk, p-value = 0.02) Ramanathan R et al. Proc ESMO 2010;Abstract 743P.

  11. Phase II Trial Schema: Hedgehog Inhibitors (GDC-0449) for Metastatic Adenocarcinoma of the Pancreas Accrual: N = 80 (open) Gemcitabine 1000 mg/m2 + nab paclitaxel 125 mg/m2 d1, 8, 15 q4wk (cycle 1)  Gemcitabine 1000 mg/m2 + nab paclitaxel 125 mg/m2 d1, 8, 15 q4wk + GDC-0449 150 mg qd (subsequent cycles) No prior radiotherapy, surgery, chemotherapy or investigational drug therapy No brain metastases ECOG PS 0-1 Primary Endpoint: 2-year progression-free survival Secondary Endpoints: 2-year overall survival, tumor response, hedgehog signaling pathway downregulation, pancreatic cancer stem cells in tissue and peripheral blood www.ClinicalTrials.gov, March 2011.

  12. Gemcitabine plus erlotinib (GE) followed by capecitabine (C) versus capecitabine plus erlotinib (CE) followed by gemcitabine (G) in advanced pancreatic cancer (APC): A randomized, cross-over phase III trial of the Arbeitsgemeinschaft Internistische Onkologie (AIO). Boeck et al. Proc ASCO 2010;Abstract LBA4011.

  13. GAMMA: Phase III Trial on Gemcitabine and AMG 479 in Advanced Pancreatic Adenocarcinoma AMG 479 12 mg/kg d1 and 15 q4wk + Gemcitabine 1000 mg/m2 d1, 8, 15 q4wk Accrual: N = 825 (open) No prior chemotherapy or radiotherapy No CNS metastases No external biliary drain Placebo d1 and 15 q4wk + Gemcitabine 1000 mg/m2 d1, 8, 15 q4wk R AMG 479 20 mg/kg d1 and 15 q4wk + Gemcitabine 1000 mg/m2 d1, 8, 15 q4wk Primary Endpoint: 2-year overall survival Secondary Endpoints: 2-year progression-free survival, objective response rate, time to disease progression, disease control rate and adverse events www.ClinicalTrials.gov, March 2011.

  14. National GI Tumor BoardClinical Investigators Provide Their Perspectives on Current Cases of Gastrointestinal CancerFriday, January 21, 20117:00 PM – 9:30 PMSan Francisco, California ModeratorNeil Love, MD Faculty Charles D Blanke, MD David Cunningham, MD Steven A Curley, MD Eileen M O’Reilly, MD Eric Van Cutsem, MD, PhD Andrew X Zhu, MD, PhD

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