Apatinib in combination with docetaxel and S‐1 chemotherapy as first‐line treatment for metastatic gastric cancer

Abstract This study aimed to evaluate the efficacy and safety of apatinib, an oral VEGFR2 tyrosine kinase inhibitor, combined with docetaxel and S‐1 (DS) as first‐line therapy for metastatic gastric cancer (mGC) patients whose median overall survival (mOS) with chemotherapy typically remains below 12 months. In this prospective, multi‐center, single‐arm phase II trial (NCT03154983), patients received docetaxel (75 mg/m 2 , day 1) and S‐1 (body surface area‐based dosing, days 1–14) every 3 weeks, plus daily apatinib (500 mg), for up to 6 planned cycles. 45 patients were enrolled, with a median follow‐up time of 12.4 months. Median progression‐free survival (PFS) and overall survival (OS) were 7.6 months (95% CI: 5.8%–9.4%) and 12.4 months (95% CI: 9.3%–15.5%), respectively in the full analysis set. Patients completing ≥4 cycles achieved a better mOS of 14.5 months (95% CI: 12.0%–17.1%). The objective response rate (ORR) and disease control rate (DCR) were 62.2% (95% CI, 46.5%–76.2%) and 82.2% (95% CI, 67.9%–92.0%), respectively, including one complete response (CR). Grade 3–4 treatment‐related adverse events occurred in 48.9% of patients, most commonly oral mucositis and neutropenia. These findings support apatinib plus DS as a promising biomarker‐independent first‐line treatment strategy for mGC.