ADJUVANT CAPECITABINE was not significantly associated with improved recurrence-free survival (RFS) or overall survival (OS) after curative-intent resection for biliary tract cancers (BTCs), according to a French multicentre real-world study.
BTCs are a heterogeneous group of malignancies, including intrahepatic, perihilar and distal cholangiocarcinoma and gallbladder carcinoma. Despite surgery offering potentially curative treatment, recurrence rates remain high and long-term survival is poor.
The retrospective study assessed 320 patients in the ACABi-PRONOBIL observational cohort: 197 received adjuvant capecitabine and 123 underwent surveillance.
After adjustment for measured differences between groups, adjuvant capecitabine was not significantly associated with RFS (HR 0.81, 95% CI 0.54–1.21; p=0.304) or OS (HR 0.94, 95% CI 0.58–1.52; p=0.798).
The RFS point estimate did suggest a possible clinical benefit, with an HR of approximately 0.80 across analyses. This estimate was consistent with the intention-to-treat RFS result from the BILCAP trial, although the wide confidence intervals reflected substantial uncertainty.
The study population was older and had more advanced disease than patients in BILCAP, with a median age of 67.9 years compared with 62 years. Intrahepatic cholangiocarcinoma was the most common primary site, accounting for 45.1% of cases.
Treatment tolerability was a notable issue. Dose reductions were required in 49% of patients, with a mean reduction of 32.6%, while 35.7% discontinued treatment, mainly because of grade 3/4 gastrointestinal and cutaneous toxicities.
The retrospective, non-randomised design limits causal interpretation, while missing pathological data and potential selection, information and classification biases may have affected the findings. The study was also restricted to France.
The findings therefore do not support changing current practice but highlight the importance of shared decision-making, patient selection and toxicity management. Prospective trials and biomarker-driven research may help identify which patients with resected BTCs are most likely to benefit from adjuvant treatment, and thus further research may benefit from increased sample sizes and patient age range.
Reference
Noé C et al. Adjuvant capecitabine in resected biliary tract cancer: a real-world data from the BILCAP-Real study (ACABi multicentre cohort). JHEP Rep. 2026;DOI: 10.1016/j.jhepr.2026.101968.
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