Objective   To investigate the efficacy and safety of paclitaxel combined with apatinib in comparison with paclitaxel alone as the second-line treatment for gastric cancer.

  Methods  Patients with advanced gastric cancer who had been treated at Chifeng Municipal Hospital, Chifeng Clinical Medical School of inner Mongolia Medical University, from March 2017 to March 2018 were enrolled. Inclusion criteria were human epidermal growth factor receptor-2(HER-2)-negative cancer and progression after the first-line treatment with fluorouracil combined with platinum. Patients were divided into groups administered with a single drug and combination of drugs. The single-drug group was administered with paclitaxel chemotherapy, while the combined-drug group with the paclitaxel combined with apatinib treatment. In both groups, the primary endpoint of observation was progression-free survival (PFS), while the secondary endpoint was the disease control rate (DCR), overall response rate (ORR), and safety.

  Results  A total of 60 patients were enrolled, including 30 patients in each of single- and combined-drug groups. PFS was significantly better in the combined-drug group than in the single-drug group (P < 0.001). DCR and ORR were higher in the combined-drug group than in the single-drug group, but without statistical significance (P>0.05). The incidence of hypertension was significantly higher in the combined-drug group than in the single-drug group (P < 0.05), while the incidence of other adverse reactions showed no significant difference between the groups (P>0.05).

  Conclusions  Paclitaxel combined with apatinib mesylate is superior to paclitaxel alone in the second-line treatment of gastric cancer. PFS, DCR, and ORR are superior with paclitaxel combined with apatinib mesylate than with paclitaxel alone. Although DCR and ORR in the combined-drug group were not significantly different from those in the single-drug group, the PFS was significantly longer in the combined-drug group, and the toxic and side effects of paclitaxel combined with apatinib mesylate were tolerable and safe.