Adjuvant capecitabine after resection of biliary tract cancer: long-term outcomes of the BILCAP study

Patients with biliary tract cancer (BTC) have poor outcomes, with five-year overall survival rate less than 10%. The multicenter phase 3 BILCAP study in the UK randomized BTC patients after curative intent resection to adjuvant oral capecitabine (eight three-week cycles) or observation. With median 106 months follow-up, in the ITT analysis the median OS was 49.6 months in the capecitabine group versus 36.1 months in de observation group (HR 0.84; 95% CI 0.67-1.06). In a protocol-specified sensitivity analysis, adjusting for minimization factors, nodal status, grade, and sex, the OS HR was 0.74 (95% CI 9,59-0,94). The authors conclude that the study suggests that adjuvant capecitabine can improve OS in patients with resected BTC.