A Phase II Trial of Paclitaxel and Cisplatin in Patients With Advanced Squamous-Cell Carcinoma of the Esophagus

作者：Xiaodong Zhang, Lin Shen, Jie Li, Yan Li, Jian Li, Maolin Jin · 发表于：American Journal of Clinical Oncology · 年份：2008 · DOI：10.1097/coc.0b013e3181131ca9 · 被引用次数：87 · 研究领域：Esophageal Cancer Research and Treatment、Gastric Cancer Management and Outcomes、Head and Neck Cancer Studies

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% CI, 11.9-22.0) and 10 months (95% CI, 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.