A phase II study of paclitaxel and cisplatin as salvage therapy for patients with advanced or metastatic gastric cancer

一项评估紫杉醇和顺铂作为晚期或转移性胃癌患者挽救治疗的II期研究

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Abstract

PURPOSE: To evaluate the therapeutic activity and safety of paclitaxel and cisplatin combination chemotherapy in patients with advanced or metastatic gastric cancers that are unresponsive to primary chemotherapy. MATERIALS AND METHODS: Advanced or metastatic gastric cancer patients unresponsive to first line chemotherapy were entered into this trial. The treatment regimen consisted of paclitaxel, 175 mg/m(2) by 3-hour infusion on day 1, and cisplatin, 60 mg/m(2) by 1 hour infusion on day 1, with the treatment repeated every 3 weeks. RESULTS: 37 patients were entered in this study, with 32 fully evaluable for response. 4 (13%), 13 (40%) and 15 (47%) patients achieved a partial response, stable disease and progressed, respectively. The median time to progression was 4.0 months (95% CI: 2.0 approximately 6.0 months), and the median overall survival was 12.6 months (95% CI: 5.5 approximately 19.7 months), with a 1-year survival rate of 54%. Of a total of 135 cycles of chemotherapy, grades 3 and 4 hematological toxicities were neutropenia (14%) and anemia (3%). Grade >or=2 neuropathy was observed in 6 patients (17%). CONCLUSION: The combination of paclitaxel and cisplatin is an effective and tolerable salvage treatment modality for advanced gastric cancer.

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