PRODIGE-24

NCT01526135 📎

Regimen

Experimental
Modified FOLFIRINOX (oxaliplatin 85 mg/m2 + irinotecan 150 mg/m2 + leucovorin 400 mg/m2 + 5-FU 2400 mg/m2 46h infusion) q2w x 12 cycles (6 months).
Control
Gemcitabine 1000 mg/m2 weekly x 3 of 4 weeks x 6 cycles.

Population

Resected pancreatic ductal adenocarcinoma (PDAC), R0 or R1, post-surgery within 3-12 weeks, ECOG PS 0-1, French-Canadian multicenter.

Key finding

PRODIGE-24 established adjuvant mFOLFIRINOX as the new standard of care for fit patients after PDAC resection, nearly doubling 5-year OS vs gemcitabine. Results adopted immediately into NCCN/ESMO guidelines and remain the reference regimen for fit (ECOG 0-1) resected patients.

Source: PMID 30575490

Timeline

    Guideline citations

    • NCCN PANCREATIC (p.118)