Phase II study of capecitabine plus cisplatin in patients with gastric cancer.

A phase II study was conducted to assess the efficacy and toxicity of combination therapy with capecitabine and cisplatin in patients with de-novo advanced gastric cancer, and in patients with refractory/recurrent gastric cancer after previous nonplatinum-based therapy. Sixty-four patients were enrolled in the study. Of these, 50 patients had untreated gastric cancer, and 14 had received previous therapy with nonplatinum-based therapy. All patients received oral capecitabine 1250 mg/m2 twice daily, days 1-14, and intravenous cisplatin 60 mg/m2 on day 1. This cycle was repeated every 3 weeks. Among the 50 previously untreated patients, three achieved complete response, and 19 had partial response, giving a response rate of 44% in the intention-to-treat population. The median time to progression and median overall survival were 6 months [95% confidence interval (CI): 1.4-10.6] and 9 months (95% CI: 5.7-12.3), respectively. In patients who had received previous therapy, clinical usefulness was evaluated resulting in response rate of 14%, disease control rate of 28.5%, and median overall survival of 4 months (95% CI: 3.1-4.9). The principal grade 3/4 adverse events were neutropenia (20%), anemia (14%). No neutropenic fever or treatment-related deaths. Capecitabine in combination with cisplatin is effective and well tolerated as first-line treatment in patients with advanced gastric cancer. Unfortunately, we could not positively suggest the usefulness of the same combination regimen as salvage therapy in patients with progressive or recurrent disease after nonplatinum-based therapy.