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Objective The aim of this study was to evaluate the efficacy and safety profile of DeFazio (S-1) combined with oxaliplatin against unresectable advanced or metastatic gastric cancer. Methods Oxaliplatin was given intravenously at 130 mg/m2 for 2 h on d1 and S-1 was administered bid. at 80 mg/m2/day on d1-14 followed by a 7-day rest during the 3-week schedule. Results All 62 patients were assessed for efficacy and adverse events. The response and disease control rates were 47.3% and 80.8%, respectively. The median time to progression was 7.8 months, and the median overall survival was 11.6 months. The grade 3/4 adverse events were hematological toxicities, including neutropenia (11.3%), thrombocytopenia (9.7%) and gastrointestinal reactions (6.5%). Conclusion The SOX regimen (oxaliplatin, 130 mg/m2 d1; S-1, 80 mg/m2/day, bid. d1-14, q3w) provide a favorable efficacy and safety profile in patients with advanced gastric cancer.
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