Efficacy and safety of capecitabine therapy in patients with Biliary tract cancer: A systematic review and meta-analysis.

BackgroundCapecitabine, an oral fluoropyrimidine prodrug, has demonstrated promising activity in Biliary tract cancers (BTC), but its role in combination chemotherapy is still debated.ObjectiveTo evaluate the efficacy and safety of capecitabine, both alone and in combination, for treating BTC.MethodologyA systematic search was performed in PubMed, Cochrane Central Register of Controlled Trials (CENTRAL), and Google Scholar from the inception to 25th June 2024 to identify the RCTs on capecitabine therapy among BTC patients. Fixed or Random-effects model was used based on heterogeneity identified by using the I² statistic and Cochran's Q test. Quality of the RCTs was evaluated by the modified JADAD scale and RoB-2.ResultsA total of six RCTs comprising 613 patients were included in the study. Pooled results showed no statistically significant differences in progression-free survival (PFS) (Mean Difference [MD]: 0.07, 95% CI: -1.32 to 1.46; P = 0.92) or overall survival (OS) (MD: -0.22, 95% CI: -1.97 to 1.53; P = 0.80) between capecitabine therapy and the control group. No significant differences in adverse events (AEs), including hand-foot syndrome, neutropenia, and thrombocytopenia.ConclusionCapecitabine did not demonstrate a statistically significant benefit in PFS or OS for patients with BTC. The AEs from the capecitabine combination therapy were well-tolerated.