As reported in the Journal of Clinical Oncology by Bridgewater et al, long-term follow-up of the phase III BILCAP study has shown a continued survival benefit with adjuvant capecitabine therapy in patients with curatively resected biliary tract cancer.
In the multicenter trial, 447 patients with curatively resected cholangiocarcinoma or muscle-invasive gallbladder cancer were randomly assigned between March 2006 and December 2014 to receive adjuvant capecitabine (n = 223) or observation (n = 224). Capecitabine was given at 1,250 mg/m2 twice daily on days 1 to 14 of 3-week cycles for 24 weeks. The primary outcome measure was overall survival; the current analysis is a prespecified analysis of long-term outcomes.
Key Findings
At data cutoff (January 2021), median follow-up was 106 months (95% confidence interval [CI] = 98–108 months). In the intention-to-treat population, median overall survival was 49.6 months (95% CI = 35.1–59.1 months) in the capecitabine group vs 36.1 months (95% CI = 29.7–44.2 months) in the observation group, with a hazard ratio of 0.84 (95% CI = 0.67–1.06) in analysis adjusted for the stratification factors of disease site, resection status, and performance status. In a protocol-specified sensitivity analysis adjusting for stratification factors, nodal status, grade, and sex, the hazard ratio was 0.74 (95% CI = 0.59–0.94).
In the per-protocol population, consisting of 210 capecitabine patients and 220 observation patients, median overall survival was 52.3 months (95% CI = 36.5–63.3 months) with capecitabine vs 36.1 months (95% CI = 29.6–42.5 months) with observation, with a hazard ratio of 0.79 (95% CI = 0.63–1.00) in analysis adjusting for stratification factors.
Median recurrence-free survival in the intention-to-treat population was 24.3 months (95% CI = 18.6–34.6 months) in the capecitabine group vs 17.4 months (95% CI = 11.8–23.0 months) in the observation group; the hazard ratio was 0.81 (95% CI = 0.65–1.01) in analysis adjusting for stratification factors. Recurrence-free survival at 5 years was 34% (95% CI = 28%–40%) in the capecitabine group and 31% (95% CI = 25%–37%) in the observation group. Among a total of 306 patients with recurrence-free survival events, 10 first experienced events over 5 years from random assignment, with the greatest risk of recurrence appearing to be at 24 months for patients in both the capecitabine and observation groups.
The investigators concluded, “This long-term analysis supports the previous analysis from the BILCAP trial, suggesting that capecitabine can improve overall survival in patients with resected biliary tract cancer when used as adjuvant chemotherapy after surgery and should be considered as the standard of care.”
John Bridgewater, MD, PhD, of UCL Cancer Institute, London, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: The study was funded by Cancer Research UK and by an unrestricted educational grant from F. Hoffmann-La Roche AG. For full disclosures of the study authors, visit ascopubs.org.
