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Capecitabine compared with observation in resected biliary tract cancer (BILCAP): A randomised, controlled, multicentre, phase 3 study

The Lancet Oncology Mar 30, 2019

Primrose JN, et al. - Researchers assessed overall survival in relation to adjuvant capecitabine (1,250 mg/m2 twice daily on days 1-14 of a 21-day cycle, for eight cycles) vs observation after surgery for biliary tract cancer. This study included patients who were aged 18 years or older who have a histologically confirmed diagnosis of cholangiocarcinoma or muscle-invasive gallbladder cancer for which they had a macroscopically complete resection (which includes liver resection, pancreatic resection, or, less commonly, both) with curative intent, as well as an Eastern Cooperative Oncology Group performance status of less than 2. Excluded patients were those with incomplete recovery from previous surgery or who had previous chemotherapy or radiotherapy for biliary tract cancer. Although the intention-to-treat population experienced no improvement in the overall survival (primary endpoint) but improved overall survival could be achieved in patients with resected biliary tract cancer who were treated with capecitabine as adjuvant chemotherapy following surgery, as revealed in the prespecified sensitivity and per-protocol analyses. Also, the safety profile was manageable. Based on these findings, capecitabine could be considered as standard of care as well as its use in this setting was supported.

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