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

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

American Journal of Clinical Oncology: February 2008 - Volume 31 - Issue 1 - p 29-33
doi: 10.1097/COC.0b013e3181131ca9
Original Article: Thoracic
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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.

From the Department of Gastrointestinal Medicine, Peking University School of Oncology, Beijing Institute for Cancer Research, Beijing Cancer Hospital, Beijing, China.

Reprints: Xiaodong Zhang, MD, Department of Gastrointestinal Medicine, Beijing Cancer Hospital, No. 52 Fucheng Rd., Haidian District, Beijing 100036, China.

© 2008 Lippincott Williams & Wilkins, Inc.