Apatinib combined with docetaxel in second-line treatment of advanced gastric cancer: A prospective randomized controlled clinical study

Abstract

Background: Antiangiogenesis therapy plays an important role in cancer treatment. Apatinib showed good safety and efficacy as third-line therapy for advanced gastric cancer. We conducted this trial to investigate the safety and efficacy of apatinib combined with docetaxel compared with docetaxel in second-line treatment of advanced gastric cancer. Method(s): Patients with advanced or metastatic gastric cancer after failure of first-line chemotherapy were randomized to receive docetaxel (60mg/m2, i.v. gtt, d1, q21d) with or without apatinib (500mg, po, qd). Study treatment was continued as a 21-day cycle until progression or intolerable toxicity. The primary endpoint was progression-free survival (PFS). The secondary endpoints were disease-free control rate (DCR), overall survival (OS) and objective response rate (ORR). All adverse events were reported using CTCAE v4.0. Tumor assessment were performed every 2 cycle. Kaplan-Meier survival analysis was used. Result(s): 59 patients were enrolled. Mean age was 55.4611.48 years in the experiment group (n = 30), and 58.76612.62 years in control group (n = 29). The average progres-sion-free survival (PFS) was 3.2263.65 months in the combined group vs 2.5262.98 months in the docetaxel group (P >0.05), which showed no significant differences. Partial response rate (PR), stable disease rate (SD), and progression disease rate (PD) were 43.33%(n=13), 16.67% (n=5), 40% (n=12)in the combined group, and 13.79% (n = 4), 17.24% (n = 5), 68.97% (n = 20) in the docetaxel group, respectively. Disease control rate in combined group was significantly higher (P Result(s): 59 patients were enrolled. Mean age was 55.4611.48 years in the experiment group (n = 30), and 58.76612.62 years in control group (n = 29). The average progres-sion-free survival (PFS) was 3.2263.65 months in the combined group vs 2.5262.98 months in the docetaxel group (P >0.05), which showed no significant differences. Partial response rate (PR), stable disease rate (SD), and progression disease rate (PD) were 43.33%(n=13), 16.67% (n=5), 40% (n=12)in the combined group, and 13.79% (n = 4), 17.24% (n = 5), 68.97% (n = 20) in the docetaxel group, respectively. Disease control rate in combined group was significantly higher (P Conclusion(s): Combination therapy with apatinib and docetaxel as a second-line treatment exhibits superior activity and manageable toxicity for patients with advanced gastric cancer.