BCAT

Regimen

Experimental
Gemcitabine 1000 mg/m2 d1, d8, d15 q4w × 6 cycles (24 weeks)
Control
Observation

Population

Resected extrahepatic bile duct cancer (ECC only — excludes GBC and ICC), R0 resection, Japan multicenter; all patients are Japanese; median age ~68 years

Key finding

BCAT unambiguously failed: gemcitabine monotherapy provided zero OS benefit over observation in resected ECC in a well-conducted Japanese phase 3 trial. Notably, BCAT enrolled only extrahepatic bile duct cancers, making it the most subtype-specific adjuvant RCT in BTC. The complete absence of any trend toward benefit (HR 1.01) definitively excludes gemcitabine mono from adjuvant recommendations for this subtype. This null result, combined with PRODIGE-12, led to the hypothesis that more potent regimens (doublet platinum-based, or the JCOG1202 oral fluoropyrimidine approach) might be needed.

Source: PMID 29405274

Timeline

    Guideline citations

    • NCCN BTC (p.14)