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

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, 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.