The Efficacy of Paclitaxel and Cisplatin Combination Chemotherapy for the Treatment of Metastatic or Recurrent Gastric Cancer: a Multicenter Phase II Study

BACKGROUND: Although many treatments for advanced gastric cancer have been developed, only poor treatment results have generally been obtained. We performed a prospective study on the combination chemotherapy of paclitaxel and cisplatin (PC). The primary objectives of the study were elucidating the disease response and evaluating the drug regimen's safety. METHODS: Patients with metastatic or recurrent gastric cancer received intravenous paclitaxel 175 mg/m(2), and cisplatin 70 mg/m(2) on day 1. This cycle was repeated every 3 weeks. RESULTS: From January 2000 to March 2004, 37 patients from 3 different hospitals were enrolled in this study. A total of 135 treatment cycles (median: 3 cycles) were administered. The responses were evaluable in 34 patients; 24 patients received this regimen as their first-line treatment for metastatic cancer and the other patients received it as their second-line treatment for recurrent cancer. The objective response rate (RR) was 26.5% (95% CI: 11.7-41.3) with two complete responses, and stable disease was observed in 41.1% of the patients. Importantly, an RR of 33.3% (95% CI: 0.6-66.0) was achieved for the eight patients who received this regimen as a first-line treatment. The median follow up duration was 14 months for all the patients, and the median time to progression was 6 months (95% CI: 1.9-10.2). The overall survival time was 8.9 months (95% CI: 7.0-11.0) with a 1-year survival rate of 18.7% (95% CI: 5.6-31.8). The most common toxicity was neutropenia. CONCLUSION: PC exhibited promising activity against gastric cancer for the previously untreated patients as a first-line treatment with an acceptable toxicity profile.