Adjuvant capecitabine in resected biliary tract cancer: a real-world data from the BILCAP-Real study (ACABi multicentre cohort)

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Abstract

BACKGROUND & AIMS: Biliary tract cancers (BTCs) are rare, heterogeneous tumors associated with a poor prognosis, even after curative-intent surgery. Adjuvant capecitabine is currently the standard of care; however, real-world data on its efficacy and tolerance are lacking. PATIENTS AND METHODS: This French, retrospective, multicentre study, nested within the ACABi-PRONOBIL observational cohort, assessed adjuvant capecitabine efficacy in patients, with resected intrahepatic, perihilar, distal cholangiocarcinoma, or gallbladder carcinoma. who had not received prior systemic therapy. Patients treated with adjuvant capecitabine after 2017 were compared with patients diagnosed before 2017 and managed with surveillance only. The primary endpoint was overall survival (OS), secondary endpoints were recurrence-free survival (RFS) and toxicity. Inverse probability of treatment weighting (IPTW) in Cox regressions was used to adjust for measured confounding, imbalanced factors between groups. RESULTS: A total of 320 patients were included (197 in the capecitabine group and 123 in the surveillance group). In IPTW analysis, adjuvant capecitabine was not significantly associated with improved RFS (IPTW HR, 0.81, CI 95%, 0.54-1.21; p = 0.304), or OS (IPTW HR, 0.94, CI 95%, 0.58-1.52; p = 0.798). The point estimate for RFS was consistent with the ITT analysis of the BILCAP trial. In the capecitabine group, 49% of patients required at least one dose reduction, and 35.7% discontinued treatment due to mainly grade 3/4 gastrointestinal (13.4%) and cutaneous (25.8%) toxicities. CONCLUSIONS: In this real-world cohort, adjuvant capecitabine was not significantly associated with improved RFS or OS in patients undergoing curative-intent resection for BTC, although a numerical trend in favor of capecitabine for RFS. These findings support the need for refined patient selection strategies and for prospective evaluation of novel adjuvant approaches. CLINICAL TRIAL REGISTRATION: NCT04935853 IMPACT AND IMPLICATIONS: This multicentre real-world study - BILCAP real study provides important complementary evidence to randomized trials by evaluating the effectiveness and tolerability of adjuvant capecitabine for resected biliary tract cancers in routine clinical practice.Although no statistically significant survival benefit was observed, the consistency of the recurrence-free survival estimate with the intention-to-treat results of the BILCAP trial and the observed toxicity profile provide clinically relevant information for physicians, patients, and multidisciplinary teams involved in postoperative treatment decisions.These findings support shared decision-making by helping clinicians balance the potential benefit of delaying recurrence against the risk of treatment-related toxicity, while emphasizing the need for careful patient selection and toxicity management in daily practice.Given the retrospective design and the possibility of residual confounding despite propensity-score adjustment, these results should be interpreted cautiously and primarily serve to inform the design of future biomarker-driven and prospective adjuvant studies rather than to change current clinical practice.

Abstract as published, via PubMed.