Second-line FOLFOX chemotherapy versus active symptom control for advanced biliary tract cancer (ABC-06): a phase 3, open-label, randomised, controlled trial.
This is the report of a phase 3 study assessing the efficacy and safety of FOLFOX in patients with previously treated advanced biliary tract cancer (BTC). 162 patients were randomized 1:1 to receive FOLFOX or active symptom control (ASC). Median overall survival (OS) was 6.2 months for FOLFOX vs 5.3 months for ASC (adjusted HR 0.69; 95%CI 0.50–0.97; p=0.031). OS rate in the FOLFOX group was 50.6% at 6 months and 25.9% at 12 months vs 35.5% at 6 months and 11.4% at 12 months in the ASC group. Median progression-free survival in the FOLFOX arm was 4.0 months. Grade 3 adverse events (AEs) were reported in 56 (69%) of 81 patients in the FOLFOX arm and in 42 (52%) of 81 patients in the ASC arm. Most common grade 3 FOLFOX-related AEs were neutropenia (12%), fatigue or lethargy (11%), and infection (10%).