Efficacy and safety of capecitabine-containing neoadjuvant chemotherapy for breast cancer: a meta-analysis of randomized controlled trials

Neoadjuvant chemotherapy (NAC) contained capecitabine in breast cancer remains controversial, thus, we conducted a meta-analysis to evaluate the efficacy and safety of this regimen. Methods: We searched the PubMed, Cochrane Library and EMBASE before December 2015. Randomized controlled trials (RCTs) that evaluated anthracycline/taxane-based NAC with or without capecitabine were included. Results: A total of 7 RCTs involving 3979 patients were included. The efficacy outcomes suggested that disease-free survival (DFS), overall survival (OS), pathological complete response (pCR), overall response rate (ORR) and breast-conserving surgery (BCS) rates were not significantly improved in the neoadjuvant chemotherapy contained capecitabine group compared to the control group (DFS: HR = 0.95, 95% CI: 0.80 to 1.12, P = 0.53; OS: HR = 0.95, 95% CI: 0.77 to 1.17, P = 0.61; pCR: HR = 1.06, 95% CI: 0.89 to 1.27, P = 0.49; ORR: HR = 1.00, 95% CI: 0.96 to 1.06, P = 0.86; BCS: HR = 0.99, 95% CI: 0.94 to 1.04, P = 0.60). Pooled OR values suggested that NAC containing capecitabine significantly increased the grade 3 to 4 adverse events (AEs) incidence of febrile neutropenia (OR = 1.49, 95% CI: 1.10 to 2.01, P = 0.010) and hand-foot syndrome (OR = 7.16, 95% CI: 3.09 to 16.60, P< 0.00001). Conclusions: Capecitabine-containing NAC regimen for breast cancer did not significantly improve the efficacy in DFS, OS, pCR, ORR and BCS, while increased the incidence of grade 3-4 AEs of febrile neutropenia and hand-foot syndrome. Thus, in short time the addition of capecitabine to NAC anthracycline/taxane-based regimen might not change clinical practice.