PRODIGE-4

NCT00112658 📎

Regimen

Experimental
FOLFIRINOX (oxaliplatin 85 mg/m2 + irinotecan 180 mg/m2 + leucovorin 400 mg/m2 + 5-FU 400 mg/m2 bolus + 2400 mg/m2 46h infusion) q2w until progression.
Control
Gemcitabine 1000 mg/m2 weekly x 7 of 8 weeks, then 3 of 4 weeks until progression.

Population

Metastatic PDAC, first-line, ECOG PS 0-1, age ≤75, bilirubin ≤1.5x ULN, French multicenter.

Key finding

PRODIGE-4/ACCORD-11 (Conroy 2011 NEJM) redefined first-line metastatic PDAC with a nearly 4.3-month OS gain over gemcitabine — the largest single-trial OS improvement in the history of metastatic PDAC. Established FOLFIRINOX as new 1L standard for fit patients (ECOG 0-1, age ≤75).

Source: PMID 21561347

Timeline

    Guideline citations

    • NCCN PANCREATIC (p.142)