ABC-02

Regimen

Experimental
Cisplatin 25 mg/m2 d1, d8 + gemcitabine 1000 mg/m2 d1, d8 q3w (GemCis), up to 8 cycles
Control
Gemcitabine 1000 mg/m2 d1, d8, d15 q4w monotherapy, up to 8 cycles

Population

Advanced (unresectable or metastatic) biliary tract cancer — intrahepatic cholangiocarcinoma ~39%, extrahepatic cholangiocarcinoma ~20%, gallbladder cancer ~38%, ampullary carcinoma ~3%; UK multicenter; treatment-naive

Key finding

ABC-02 is the foundational 1L advanced BTC trial that established GemCis as the standard of care for over a decade. The 3.6-month median OS improvement and HR of 0.64 were highly significant and reproducible (BT22 Japanese confirmatory trial also positive). Tolerability was broadly acceptable. The trial set the backbone that TOPAZ-1, KEYNOTE-966, and SWOG-1815 would all build upon. One key caveat: the survival was still only 11.7 months median, illustrating the unmet need that drove the subsequent IO combination era.

Source: PMID 20375404

Timeline

    Guideline citations

    • NCCN BTC (p.70)