Efficacy and safety of adjuvant low-dose apatinib combined with SOX regimen versus SOX regimen in patients with resectable locally advanced gastric cancer: a cohort study

Objective Apatinib combined with S‐1 and oxaliplatin (SOX) synergistically improves the prognosis of advanced gastric cancer patients, but its application as an adjuvant regimen has rarely been reported. This study aimed to investigate the efficacy and safety of adjuvant low-dose apatinib combined with SOX versus SOX alone in patients with resectable locally advanced gastric cancer. Methods This cohort study included 110 patients with locally advanced gastric cancer (pTNM stage III) who underwent radical surgery. Among these patients, 70 patients received adjuvant low-dose apatinib (250 mg/day) combined with SOX regimen (named apatinib + SOX group), and 40 patients received adjuvant SOX regimen alone (named SOX group). Disease-free survival (DFS) and adverse events were recorded. Results DFS was longer in apatinib + SOX group versus SOX group ( P = 0.004). Specifically, the median DFS was not reached, and the 1-year/2-year cumulating DFS rates reached 75.7%/61.4% in apatinib + SOX group, whereas the median DFS was 15.0 (95% confidence interval: 10.0–20.0) months, and the 1-year/2-year accumulating DFS rates were 57.5%/35.0% in SOX group. After adjustment by multivariate Cox regression, apatinib + SOX (versus SOX) was independently related to prolonged DFS (hazard ratio = 0.316, P < 0.001). Moreover, hypertension showed a higher tendency in apatinib + SOX group compared to SOX group (22.9% versus 10.0%, P = 0.093), but did not reach statistical significance. However, incidences of other adverse events were not different between the two groups including: nausea and vomiting ( P = 1.000), fatigue ( P = 0.709), leukopenia ( P = 0.103), pain ( P = 0.564), thrombocytopenia ( P = 0.113), anorexia ( P = 0.564), and anemia ( P = 0.686). Conclusion Low-dose apatinib combined with SOX may be a feasible adjuvant regimen in patients with resectable locally advanced gastric cancer.