BILCAP: capecitabine compared with observation in resected biliary tract cancer
Six months of capecitabine tablets after surgery for bile duct or gallbladder cancer lengthened survival by about a year in the per-protocol analysis, and became the standard adjuvant treatment despite narrowly missing its primary endpoint.
Overview
Phase 3 trial of 447 patients with completely resected cholangiocarcinoma (intrahepatic, perihilar or distal) or gallbladder cancer randomised to eight cycles of capecitabine or observation.
In the intention-to-treat analysis median overall survival was 51.1 versus 36.4 months (hazard ratio 0.81, not significant); in the prespecified per-protocol analysis it was 53 versus 36 months (hazard ratio 0.75, significant), and the adjusted analysis and long-term follow-up supported benefit.
- Intention to treat: median overall survival 51.1 vs 36.4 months; hazard ratio 0.81 (not significant).
- Per protocol: 53 vs 36 months; hazard ratio 0.75.
Adjuvant capecitabine is the standard after resection of intrahepatic and extrahepatic cholangiocarcinoma and gallbladder cancer, endorsed by ASCO and ESMO guidelines.
- Primary endpoint not met in the intention-to-treat population.
- Whether gemcitabine-cisplatin or chemo-immunotherapy adjuvant regimens are better is under study.
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