Abstract: AIM: To investigate the efficacy and safety of apatinib combined with capecitabine in the treatment of advanced triple-negative breast cancer (TNBC) as third-line therapy. METHODS: Sixty advanced TNBC patients, who have failed to receive second-line palliative chemotherapy, were enrolled in the Department of Oncology, Anqing Hospital Affiliated to Anhui Medical University from February 2016 to September 2019. Patients were divided into observation group (n=30, received apatinib combined with capecitabine) and control group (n=30, received capecitabine) randomly. The objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), 1-year survival rate, overall survival (OS) and adverse events between the two groups were observed and compared. RESULTS:ORR was 26.67% and DCR was 86.67% in the observation group, while 6.67% and 60.00% in the control group, respectively. ORR and DCR in the observation group were better than those in the control group (P=0.038; 0.020). Meanwhile, the median PFS was 7.0 months in the observation group, while it was 5.0 months in the control group, which indicated that the observation group exhibited a higher PFS than the control group (P=0.000). The 1-year survival rate and the median OS was 55.30% and 13.0 months in the observation group respectively, while those were 46.30% and 12.0 months in the control group respectively, the OS showed no significant differences between the two groups (P=0.258). In addition, we also found that there was significant differences in the adverse reaction such as hypertension between the two groups (P=0.000), yet it was mild and tolerable after symptomatic treatment. CONCLUSION:Apatinib combined with capecitabine in the advanced TNBC maintenance treatment has a certain survival benefit for those who failed in second-line therapy, and adverse reactions are tolerable and controllable.

Key words: apatinib, antiangiogenic drugs, capecitabine, triple-negative breast cancer