AMEBICA

Regimen

Experimental
Modified FOLFIRINOX: oxaliplatin 85 mg/m2 + irinotecan 180 mg/m2 + leucovorin 400 mg/m2 + 5-FU 400 mg/m2 bolus + 5-FU 2400 mg/m2 46h infusion, q2w
Control
GemCis: gemcitabine 1000 mg/m2 + cisplatin 25 mg/m2 d1, d8 q3w

Population

Advanced BTC (unresectable/metastatic), 1L treatment-naive; ICC ~55%, ECC ~20%, GBC ~22%, ampullary ~3%; France multicenter (PRODIGE/FFCD); predominantly Caucasian

Key finding

AMEBICA/PRODIGE-38 showed that mFOLFIRINOX is not superior to GemCis as 1L therapy for advanced BTC. Neither PFS nor OS favored the triplet, and toxicity was numerically higher with mFOLFIRINOX (Grade 3-4 adverse events ~72% vs ~60%). This is a phase 2 RCT designed as a selection/screening trial rather than a definitive superiority trial. The negative result is consistent with SWOG-1815's finding that adding cytotoxic complexity to the GemCis backbone is not beneficial in unselected BTC. However, mFOLFIRINOX remains of interest for specific high-volume disease contexts and as a salvage backbone.

Source: PMID 34662180

Timeline

    Guideline citations

    • NCCN BTC (p.100)