Docetaxel and cisplatin combination chemotherapy for advanced gastric cancer failed to 5-fluorouracil-based chemotherapy.

Background :There is no effective treatment in patients with advanced gastric cancer failed to first - line chemotherapy. Taxane is one of new drugs identified as having substantial activity in gastric cance. We performed a phase II trial to evaluate the efficacy and toxicity of docetaxel plus cisplatin regimen as a salvage chemotherapy for advanced gastric cancer failed to 5- fluorouracil (5-FU)-based chemotherapy. Methods : Metastatic or recurrent gastric cancer patients failed to 5-FU-based regimen with an Eastern Cooperative Oncology Group (ECOG) were eligible in this trial. Docetaxel (60 mg/m) was infused over 1 hour, before cisplatin (60 mg/m) infused over 2 hours on day 1, once every 3 weeks until disease progression or unacceptable toxicity was detected. Response to treatment was assessed every two or three cycles. Results : From October 1999 to December 2000, forty-one patients were enrolled in this study. Twenty-eight of forty-one patients were assessable for response. Partial response was observed in seven patients and stable disease in four patients. The response rate was 25.0% (95% confidence interval: 20.4-29.6%) and median duration of response was 22 weeks (range: 11-53 weeks). The median survival of all enrolled patients was 24 weeks (range: 7-65 weeks). For a total of 112 cycles of chemotherapy, grade 3 and 4 toxicity was 8.9% for neutropenia, 4.5% for nausea/vomiting and 1.8% for mucositis. Conclusion :Salvage chemotherapy with docetaxel plus cisplatin regimen in gastric cancer was active with acceptable toxicities.