Copyright © 2011 Research To Practice. All rights reserved. Case presented by Dr Schwartz 44 yo woman with 4 mo hx of abdominal pain –Imaging = pancreatic.

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Copyright © 2011 Research To Practice. All rights reserved. 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

Copyright © 2011 Research To Practice. All rights reserved. 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.

Copyright © 2011 Research To Practice. All rights reserved. Conroy T et al. Proc ASCO 2010;Abstract AE (% per patient) FOLFIRINOX (n = 167) Gemcitabine (n = 169)p-value Febrile neutropenia Thrombocytopenia Peripheral neuropathy Vomiting Diarrhea ALT FOLFIRINOX regimen is more toxic, but toxicity is manageable PRODIGE 4/ACCORD 11: Selected Grade 3/4 Adverse Events (AE)

Copyright © 2011 Research To Practice. All rights reserved. Conroy T et al. Proc ASCO 2010;Abstract Efficacy Parameter FOLFIRINOX (n = 171) Gemcitabine (n = 171) Hazard ratio (p-value) Disease control rate (CR + PR + SD) 70.2% (0.6% + 31% %) 50.9% (0% + 9.4% %) — (0.0003) Progression15.2%34.5%— Progression-free survival 6.4 months3.3 months0.47 (<0.0001) Overall survival11.1 months6.8 months0.57 (<0.0001) FOLFIRINOX recommended as new standard of care for metastatic pancreatic cancer with bilirubin <1.5 ULN and PS 0-1 PRODIGE 4/ACCORD 11: Efficacy Median follow-up: 26.6 months

Copyright © 2011 Research To Practice. All rights reserved. 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); Refinement of adjuvant therapy for pancreatic cancer O’Reilly EM et al. JAMA 2011; 304(10);

Copyright © 2011 Research To Practice. All rights reserved. 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

Copyright © 2011 Research To Practice. All rights reserved. TrialMedian Overall Survival ESPAC-1 ‡ Chemoradiotherapy No chemoradiotherapy Chemotherapy No chemotherapy 15.9 mos 17.9 mos 20.1 mos 15.5 mos ESPAC-3 5-FU/folinic acid Gemcitabine 23.0 mos 23.6 mos Efficacy Results from the European Study Group for Pancreatic Cancer (ESPAC) 1 and 3 Trials Neoptolemos JP et al. N Engl J Med 2004;350: ; Neoptolemos JP et al. JAMA 2010;304(10): ‡ Median follow-up: 47 months Median follow-up: 34 months

Copyright © 2011 Research To Practice. All rights reserved. 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

Copyright © 2011 Research To Practice. All rights reserved. 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.

Copyright © 2011 Research To Practice. All rights reserved. Ramanathan R et al. Proc ESMO 2010;Abstract 743P. Efficacy (n = 67) Complete response4% Partial response42% Stable disease >16 weeks18% Median survival (all arms)10.3 months 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) Efficacy of Nab Paclitaxel + Gemcitabine for Advanced Pancreatic Cancer

Copyright © 2011 Research To Practice. All rights reserved. No prior radiotherapy, surgery, chemotherapy or investigational drug therapy No brain metastases ECOG PS 0-1 Phase II Trial Schema: Hedgehog Inhibitors (GDC- 0449) for Metastatic Adenocarcinoma of the Pancreas Gemcitabine 1000 mg/m 2 + nab paclitaxel 125 mg/m 2 d1, 8, 15 q4wk (cycle 1)  Gemcitabine 1000 mg/m 2 + nab paclitaxel 125 mg/m 2 d1, 8, 15 q4wk + GDC mg qd (subsequent cycles) Accrual: N = 80 (open) 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 March 2011.

Copyright © 2011 Research To Practice. All rights reserved. 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.

Copyright © 2011 Research To Practice. All rights reserved. No prior chemotherapy or radiotherapy No CNS metastases No external biliary drain GAMMA: Phase III Trial on Gemcitabine and AMG 479 in Advanced Pancreatic Adenocarcinoma AMG mg/kg d1 and 15 q4wk + Gemcitabine 1000 mg/m 2 d1, 8, 15 q4wk R Placebo d1 and 15 q4wk + Gemcitabine 1000 mg/m 2 d1, 8, 15 q4wk Accrual: N = 825 (open) AMG mg/kg d1 and 15 q4wk + Gemcitabine 1000 mg/m 2 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 March 2011.

Copyright © 2011 Research To Practice. All rights reserved. Faculty National GI Tumor Board Clinical Investigators Provide Their Perspectives on Current Cases of Gastrointestinal Cancer Friday, January 21, :00 PM – 9:30 PM San Francisco, California Moderator Neil Love, MD Eileen M O’Reilly, MD Eric Van Cutsem, MD, PhD Andrew X Zhu, MD, PhD Charles D Blanke, MD David Cunningham, MD Steven A Curley, MD