Randomized phase III trial comparing FOLFIRINOX (F: 5FU/leucovorin [LV], irinotecan [I], and oxaliplatin [O]) versus gemcitabine (G) as first-line treatment for metastatic pancreatic adenocarcinoma (MPA): Preplanned interim analysis results of the PRODIGE 4/ACCORD 11 trial.

4010 Background: In a randomized phase II trial of F vs G in 88 MPA patients (pts), we reported that F induces a response rate > 30% (Ychou, ASCO 2007). Because the trial met its planned objectives, it has been pursued as a phase III to compare overall survival (OS). Methods: Chemotherapy-naive pts aged 18-75 years with histologically/cytologically-confirmed measurable MPA were randomized to receive F (O 85 mg/m2 d1 + I 180 mg/m2 d1 + LV 400 mg/m2 d1 followed by 5FU 400 mg/m2 bolus d1 and 2,400 mg/m2 46h continuous infusion biweekly) or G (1g/m2 IV weekly x7, 1 w rest, then weekly × 3q4w). Eligibility included adequate organ function, performance status (PS) 0-1, no prior chemotherapy or radiotherapy. Pts were stratified by centre, PS, and primary tumor location (head vs. other). The primary endpoint was OS. With a planned sample size of 360 pts, the trial was designed to detect an improvement from 7 to 10 months (m) median survival (HR = 0.70) with 80% power and α = 0.05. Results: 342 pts were enrolled b...