A Phase II Study of Paclitaxel and Cisplatin as Salvage Therapy for Patients with Advanced or Metastatic Gastric Cancer

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/m2 by 3-hour infusion on day 1, and cisplatin, 60 mg/m2 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: 2.0～6.0 months), and the median overall survival was 12.6 months (95% CI: 5.5～19.7 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 ≥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. (Cancer Res Treat. 2007; 39:6-9) V