Transcript Document
National GI Tumor Board Clinical Investigators Provide Their Perspectives on Current Cases of Gastrointestinal Cancer Friday, January 21, 2011 7:00 PM – 9:30 PM San Francisco, California Moderator Neil 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 Copyright © 2011 Research To Practice. All rights reserved. Case presented by Dr Polkinghorn • 22 yo woman, married, teacher • 7/2010: Abdominal pain workup reveals cystic mass in pancreas and multiple hepatic lesions – Biopsy = pancreatic adenocarcinoma – FOLFIRINOX - no response, substantial toxicity • Switched to gemcitabine and erlotinib – Again, substantial toxicity – Scans are “stable” in pancreas and liver mets, small in spleen lesions • BRCA testing - negative Copyright © 2011 Research To Practice. All rights reserved. Copyright © 2011 Research To Practice. All rights reserved. Case presented by Dr Polkinghorn • 22 yo woman, married, teacher • 7/2010: Abdominal pain workup reveals cystic mass in pancreas and multiple hepatic lesions – Biopsy = pancreatic adenocarcinoma – FOLFIRINOX - no response, substantial toxicity • Switched to gemcitabine and erlotinib – Again, substantial toxicity – Scans are “stable” in pancreas and liver mets, small in spleen lesions • BRCA testing - negative 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. PRODIGE 4/ACCORD 11: Efficacy FOLFIRINOX (n = 171) Gemcitabine (n = 171) Hazard ratio (p-value) 70.2% (0.6% + 31% + 38.6%) 50.9% (0% + 9.4% + 41.5%) — (0.0003) 15.2% 34.5% — Progression-free survival 6.4 months 3.3 months 0.47 (<0.0001) Overall survival 11.1 months 6.8 months 0.57 (<0.0001) Efficacy Parameter Disease control rate (CR + PR + SD) Progression 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. Copyright © 2011 Research To Practice. All rights reserved. PRODIGE 4/ACCORD 11: Selected Grade 3/4 Adverse Events (AE) FOLFIRINOX (n = 167) Gemcitabine (n = 169) p-value Febrile neutropenia 5.4 0.6 0.009 Thrombocytopenia 9.1 2.4 0.008 Peripheral neuropathy 9.0 0 0.0001 Vomiting 14.5 4.7 0.002 Diarrhea 12.7 1.2 0.0001 ALT 7.3 18.6 0.0022 AE (% per patient) FOLFIRINOX regimen is more toxic, but toxicity is manageable Conroy T et al. Proc ASCO 2010;Abstract 4010. Copyright © 2011 Research To Practice. All rights reserved. National GI Tumor Board Clinical Investigators Provide Their Perspectives on Current Cases of Gastrointestinal Cancer Friday, January 21, 2011 7:00 PM – 9:30 PM San Francisco, California Moderator Neil 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 Copyright © 2011 Research To Practice. All rights reserved. Case presented by Dr Polkinghorn • 22 yo woman, married, teacher • 7/2010: Abdominal pain workup reveals cystic mass in pancreas and multiple hepatic lesions – Biopsy = pancreatic adenocarcinoma – FOLFIRINOX - no response, substantial toxicity • Switched to gemcitabine and erlotinib – Again, substantial toxicity – Scans are “stable” in pancreas and liver mets, small in spleen lesions • BRCA testing - negative Copyright © 2011 Research To Practice. All rights reserved. A phase II trial of nab-paclitaxel in patients with advanced pancreatic cancer who have progressed on gemcitabine-based therapy Hosein JP et al. Proc ASCO 2010;Abstract 4120. Copyright © 2011 Research To Practice. All rights reserved. Nab-paclitaxel monotherapy after gemcitabine based therapy Efficacy (n = 19) Time point (months) PFS OS 3 31.6% 73.7% 6 15.8% 57.9% 9 5.3% 47.4% 12 5.3% 36.8% 1.6 months 7.3 months Median Hosein PJ et al. Proc ASCO 2010;Abstract 4120 Copyright © 2011 Research To Practice. All rights reserved. Case presented by Dr Polkinghorn • 22 yo woman, married, teacher • 7/2010: Abdominal pain workup reveals cystic mass in pancreas and multiple hepatic lesions – Biopsy = pancreatic adenocarcinoma – FOLFIRINOX - no response, substantial toxicity • Switched to gemcitabine and erlotinib – Again, substantial toxicity – Scans are “stable” in pancreas and liver mets, small in spleen lesions • BRCA testing - negative Copyright © 2011 Research To Practice. All rights reserved.