PRODIGE 4/ACCORD 11 — FOLFIRINOX Versus Gemcitabine for Metastatic Pancreatic Cancer

Phase 2/3 · 2011 · Pancreatic Cancer

Design

Randomized trial comparing FOLFIRINOX (5-FU/leucovorin, irinotecan, oxaliplatin) versus gemcitabine monotherapy in first-line metastatic disease.

Population

Untreated metastatic pancreatic adenocarcinoma with ECOG performance status 0-1.

Primary Endpoint

overall survival (OS)

Key Result

Median OS 11.1 vs 6.8 months (HR 0.57); median PFS 6.4 vs 3.3 months, at the cost of greater toxicity.

Guideline Impact

NCCN category 1 first-line for metastatic pancreatic cancer (good PS)