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

Abstract

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/m2, and cisplatin 70 mg/m2 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.

Keywords: Stomach Neoplasms, Paclitaxel