A phase II study of biweekly paclitaxel and cisplatin chemotherapy for recurrent or metastatic esophageal squamous cell carcinoma: ERCC1 expression predicts response to chemotherapy.

Recurrent or metastatic esophageal cancer has poor prognosis. This study was to assess the efficacy and safety of biweekly paclitaxel and cisplatin combination for patients with recurrent or metastatic esophageal squamous cell carcinoma. The excision repair cross-complementation group 1 (ERCC1) expression to predict response is also assessed. Forty-six eligible patients were enrolled. Paclitaxel was given at 150 mg/m(2) over 3 h on day 1, and cisplatin was given at 50 mg/m(2) on day 2, every 2 weeks as one cycle. ERCC1 protein expression was assessed by immunohistochemistry staining. The overall response rate was 56.5 % (26/46, 95 % CI 42.2-70.8 %). Progression-free survival was 5.6 months (95 % CI, 2.8-8.4 months), and the median actuarial survival time was 17.0 months (95 % CI, 12.3-21.7 months). There was a significant difference in median actuarial survival between the patients with a response compared to the non-responders (22.8 months vs. 7.4 months, P < 0.0001). Overall survival at 1 year was 65.0 %, and at 2 years was 34.0 %, respectively. The most frequent toxicity for all patients was neutropenia (37.0 and 23.9 % for grades 3 and 4, respectively). Patients with ERCC1 negative tumors had a higher treatment response than the ERCC1 positive group (radiological response rates; 92.3 % vs.50 %, P = 0.013). Biweekly chemotherapy with paclitaxel and cisplatin was found to be active and generally well tolerated. Our study indicates that the expression of ERCC1 evaluated by immunohistochemistry is a promising predictive marker for response in patients with metastatic ESCC receiving cisplatin-paclitaxel regimen.