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% 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.


CONCLUSIONS
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.
Zhang
Xiaodong
X
Department of Gastrointestinal Medicine, Peking University School of Oncology, Beijing Institute for Cancer Research, Beijing Cancer Hospital, Beijing, China.
Shen
Lin
L
Li
Jie
J
Li
Yan
Y
Li
Jian
J
Jin
Maolin
M
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001859:Bone Neoplasms / Q000188:drug therapy / Q000556:secondary; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000556:secondary; D017024:Chemotherapy, Adjuvant; D002945:Cisplatin / Q000008:administration & dosage; D004938:Esophageal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008113:Liver Neoplasms / Q000188:drug therapy / Q000556:secondary; D008175:Lung Neoplasms / Q000188:drug therapy / Q000556:secondary; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy; D017239:Paclitaxel / Q000008:administration & dosage; D015996:Survival Rate
D017239:Paclitaxel; D002945:Cisplatin