A pilot trial of docetaxel and nedaplatin in cisplatin-pretreated relapsed or refractory esophageal squamous cell cancer.

Objective: This study documents the clinical efficacy and toxicity of docetaxel and nedaplatin in cisplatin-pretreated relapsed or refractory esophageal squamous cell cancer.

Methods: From February 2002 to February 2007, 20 patients with metastatic or locally recurrent or residual disease previously treated with cisplatin-based chemotherapy or chemoradiotherapy were included. The median age was 66.0 (range 52-74) years, and 17 patients had undergone a previous esophagectomy. A total of 36 cycles with docetaxel 60 mg/m2 plus nedaplatin 80 mg/m2 were administered.

Results: The response rate was 25% including one complete response, and the rate of disease stabilization (% of complete response, partial response and stable disease) was 80%. The median progression-free survival was 14 weeks and the median overall survival was 26 weeks. Severe neutropenia occurred in 12 patients (grade 3/4 = 4/8) and 5 out of 20 patients showed severe febrile neutropenia (grade 3/4 = 4/1), whereas no severe non-hematological toxicity was observed.

Conclusions: In conclusion, the combination chemotherapy of docetaxel and nedaplatin did not show drastic clinical efficacy. However, it was considered to be a feasible regimen as tumor dormancy therapy in CDDP-pretreated esophageal cancer, and to have a potent possibility to become a useful second-line chemotherapy for relapsed or refractory esophageal cancer. The control and prevention of severe neutropenia and febrile neutropenia is also very important in use of this regimen.