Multicenter phase 2 trial of first-line apatinib plus docetaxel and S-1 for metastatic gastric cancer

The median overall survival (OS) for patients with metastatic gastric cancer (mGC) with chemotherapy typically remains below 12 months. A multicenter phase 2 trial in China evaluated the combination of afatinib (VEGFR2 TKI) with docetaxel and S-1 chemotherapy as first-line treatment for mGC. Patients received up to 6 three-week cycles of apatinib 500 mg once daily with docetaxel on day 1 and S-1 on days 1-14. Forty-five patients were enrolled, with a median follow-up of 12.4 months. The objective response rate and disease control rate were 62.2% and 82.2%, respectively, including one complete response. Grade 3-4 treatment-related adverse events occurred in 48.9% of patients, most commonly oral mucositis and neutropenia. Median progression-free survival and overall survival were 7.6 months (95% CI 5.8-9.4) and 12.4 months (9.3-15.5), respectively, with patients completing 4 or more cycles achieving a median overall survival of 14.5 months (12.0-17.1). The authors conclude that these findings support this regimen as first-line therapy for mGC.