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Background  The role of capecitabine in neoadjuvant and adjuvant chemotherapy for early-stage triple-negative breast cancer (TNBC) is highly controversial. Our meta-analysis was designed to further elucidate the effects of capecitabine on survival in early-stage TNBC patients and its safety.    Methods  PubMed, Embase, and papers presented at several main conferences were searched up to December 19, 2019, to investigate capecitabine-based versus capecitabine-free neoadjuvant and adjuvant chemotherapy in TNBC patients. Heterogeneity was assessed using  I  2  test, combined with hazard ratios (HRs) and odds ratios (ORs) with 95% confidence intervals (CI) computed for disease-free survival (DFS), overall survival (OS), and over grade 3 adverse events (AEs).    Results  A total of 9 randomized clinical trials and 3842 TNBC patients were included. Overall, the combined capecitabine regimens in neoadjuvant and adjuvant chemotherapy showed significantly improved DFS (HR = 0.75; 95% CI, 0.65–0.86;  P  < 0.001) and OS (HR = 0.63; 95% CI, 0.53–0.77;  P  < 0.001). In subgroup analysis, there were improvements in DFS in the groups with addition of capecitabine (HR = 0.64; 95% CI, 0.53–0.78;  P  < 0.001), adjuvant chemotherapy (HR = 0.73; 95% CI, 0.63–0.85;  P  < 0.001), and lymph node positivity (HR = 0.62; 95% CI, 0.44–0.86;  P  = 0.005). Capecitabine regimens were related to higher risks of diarrhea (OR = 2.88, 95% CI 2.23–3.74,  P  < 0.001), stomatitis (OR = 2.01, 95% CI 1.53–2.64,  P  < 0.001) and hand–foot syndrome (OR = 8.67, 95% CI 6.70–11.22,  P  < 0.001).    Conclusion  This meta-analysis showed that neoadjuvant and adjuvant chemotherapy combined with capecitabine significantly improved both DFS and OS in early-stage TNBC patients with tolerable AEs. There were benefits to DFS in the groups with the addition of capecitabine, adjuvant chemotherapy, and lymph node positivity.    Supplementary Information  The online version contains supplementary material available at 10.1186/s12885-021-07791-y.

bmc cancer

The role of capecitabine-based neoadjuvant and adjuvant chemotherapy in early-stage triple-negative breast cancer: a systematic review and meta-analysis