Currently, S-1 combined with oxaliplatin (SOX) is widely used in the first-line treatment of advanced gastric cancer in China. Apatinib has demonstrated encouraging anti-cancer activity in gastric cancer within both in vitro and in vivo models. We evaluated the efficacy and safety of apatinib combined with SOX in initially treated patients with metastatic gastric cancer.
In this single arm study, patients with unresectable metastatic gastric adenocarcinoma was enrolled to received chemotherapy with apatinib (500mg, once daily) and SOX regimen. Oxaliplatin was administered at a dose of 130 mg/m2 on day 1, and S-1 (40–60 mg depending on patient’s body surface area) was given orally twice daily for 2 consecutive weeks followed by a 1-week rest. The primary end point was response rates, Secondary endpoints were safety, median progression-free survival and median overall survival.
Thirty-one eligible patients were enrolled between January 2016 and September 2017. Two patients achieved a complete response and 19 patients had partial response. The objective response rates was 67.7%. Seven patients had stable disease and the disease control rates was 90.3%. Disease progression was seen in 3 cases (9.7%). Progression-free survival was 5.9 months (95% confidence interval: 3.2–12.6) and median overall survival was 13.6 months (95% confidence interval: 7.3–22.1). The most common grade 3 to 4 hematologic adverse events (AE) were leucopenia (12.9%), neutropenia (38.7%), thrombocytopenia (6.5%) and anaemia (25.8%), nonhematologic AE were nausea (12.9%), anorexia (32.3%), hand-foot syndrome (6.5%), hypertension (9.7%) and proteinuria (3.2%). No treatment-related death was documented during the drug administration.
Apatinib plus SOX is effective for initially treated metastatic gastric cancer with more favorable safety.
Clinical trial identification
Legal entity responsible for the study
Has not received any funding.
Approved by the hospital ethics committee of the first affiliated hospital of Sun Yat-sen University (SYU).
All authors have declared no conflicts of interest.