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

2008; Lippincott Williams & Wilkins; Volume: 31; Issue: 1 Linguagem: Inglês

10.1097/coc.0b013e3181131ca9

1537-453X

Xiaodong Zhang, Lin Shen, Jie Li, Yan Li, Jian Li, Maolin Jin,

Lung Cancer Treatments and Mutations

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/m2 and cisplatin 75 mg/m2 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.