Clinical Value of Capecitabine-Based Combination Adjuvant Chemotherapy in Early Breast Cancer: A Meta-Analysis of Randomized Controlled Trials.

Capecitabine has consistently demonstrated high efficacy and acceptable tolerability in salvage chemotherapy for advanced breast cancer. However, there remains no consensus on its role in adjuvant chemotherapy for early breast cancer (EBC). To estimate the value of capecitabine-based combination adjuvant treatment in EBC, eight randomized controlled trials with 14,072 participants were analyzed. The efficacy and safety outcomes included disease-free survival (DFS), overall survival (OS), relapse, breast cancer-specific survival (BCSS), and grades 3-5 adverse events. Capecitabine-based combination adjuvant chemotherapy demonstrated a 16% increase in BCSS (HR = 0.84, 95% CI = 0.71-0.98, p = 0.03) in the overall analysis and a 22% improvement in DFS (HR = 0.78, 95% CI = 0.64-0.96, p = 0.02) in the hormone receptor-negative (HR-) subgroup. However, there were no significant differences in DFS (HR = 0.96, 95% CI = 0.89-1.05, p = 0.38), OS (HR = 0.91, 95% CI = 0.82-1.00, p = 0.06), or relapse between capecitabine-based and capecitabine-free combination adjuvant chemotherapy. Analogous results were observed in the subgroup analyses of HR+, HER2-, HER2+, and triple-negative EBC. Regarding safety, reduced myelosuppression and hand-foot syndrome development were observed in capecitabine-treated patients. Capecitabine-based combination adjuvant chemotherapy might provide some BCSS benefit compared with capecitabine-free regimens in EBC, but the absolute survival gain is small, and the survival benefit appears to be restricted to patients with HR- EBC, which may indicate a target population for capecitabine-based combination adjuvant chemotherapy.