Abstract: Objective To compare the efficacy and safety of vinorelbine （NVB） plus capecitabine （XLD） and vinorelbine （NVB） plus compound tegafur capsule （S-1） in advanced breast cancer patients after anthracyclinetaxane failure. Methods From June 2012 to June 2014， 64 metastatic breast cancer patients with anthracycline-taxane failure from our hospital were enrolled. According to the treatment regimes， 33 patients received NVB plus XLD regime （NX group） and 31 patients received NVB plus S-1 regime （NS group）. All patients in NX group were given 25 mg／m2 of NVB on day 1 and 8 plus 2 000 mg／m2 of XLD daily from day 1 to 14. All patients in NS group received 25 mg／m2 of NVB at day 1 and day 8 plus oral S-1 twice every day from day 1 to 14. The dose of S-1 was determined according to the body surface area as follows：≤1.25 m2， 40 mg； 1.25 to ＜1.5 m2， 50 mg； and≥1.5 m2， 60 mg. Three weeks was a cycle. Response to chemotherapy was assessed by RECIST criteria 1.1 after 2 cycles. Toxicity was evaluated according to Common Terminology Criteria for Adverse Events （CTCAE） v4.0. Patients were followed up for survival.
Results All the 64 patients were evaluable for response. In NX group， there were 3 cases of CR， 13 cases of PR， 12 cases of SD and 5 cases of PD with the response rate （RR） and disease control rate （DCR） of 48.5％ and 84.8％. In NS group， there were 3 cases of CR， 13 cases of PR， 8 cases of SD and 7 cases of PD with RR and DCR of 51.6％ and 77.4％. No significant difference was observed on RR and DCR between both groups （P＞0.05）. The median progressionfree survival were 7.8 months and 7.2 months in the NX group and NS group， and there was no significant difference between both group （P＞0.05）. The main adverse reactions of both groups were myelosuppression and digestive tract reaction， mainly of grade 1-2， which could be tolerated. The incidence of hand foot syndrome in group NX was higher than that in NS group （45.5％ vs. 16.1％）， and the difference was statistically significant （P＜0.05）. Conclusion Similar clinical efficacy is achieved in the therapy of metastatic breast cancer with NVB plus XLD or S-1. The side effects are mild and tolerable， and the incidence of hand foot syndrome is lower in NVB plus S-1 regimen. Both regimens were worthy of clinical promotion.