A phase II trial of paclitaxel and cisplatin in patients with advanced squamous-cell carcinoma of the esophagus

Objective: To evaluate the response rate, survival, and toxicities of paclitaxel plus cisplatin combination in patients with advanced or metastatic squamous-cell carcinoma of the esophagus. Methods: Thirty-nine patients with definite measurable indices and no prior chemotherapy were enrolled. Patients were treated with paclitaxel 175 mg/m(2) and cisplatin 75 mg/m(2) by 2-hour infusion on day 1. Treatment was repeated every 21 days. Results: Thirty-nine patients were enrolled of which 35 patients were eligible to be evaluated to have had a response. The overall response rate was 48.6% [95% confidence interval (CI), 0.31-0.65 with complete and partial response rates of 2.8% and 45.7%, respectively. The median time to progression was 7 months, and median survival time of all patients was 13 months. There was a significant difference in the median overall survival between the patients who had showed response versus those who had not (P = 0.006). Median survival was 17 (95% Cl, 11.9-22.0) and 10 months (95% Cl, 7.6-12.4), respectively. The 1-year survival probability was 39%. Relief of dysphagia and pain were observed in 86.2% of all the patients. The most common toxicities were neutropenia and alopecia. No grade 4 toxicities and treatment-related deaths were recorded in all patients. Conclusion: Paclitaxel and cisplatin is a promising treatment for patients with squamous-cell carcinoma of the esophagus. The toxicity of this regimen is within acceptable range.