Carboplatin and docetaxel in advanced non-small-cell lung cancer: results of a multicenter phase II study

Background: To evaluate the efficacy of carboplatin and docetaxel combination in patients with advanced non-small-cell lung cancer. Methods: In a phase II study, patients with inoperable stage IIIB or stage IV non-small-cell lung cancer (ECOG performance status of 0 or 1) were treated with the combination of carboplatin AUC 5 mg/ml.min and docetaxel 80 mg/m(2) administered once every 3 weeks. Results: A total of 45 patients were accrued to the study. The median age was 62 years and adenocarcinoma was the most common histology. Patients received a median of four cycles of chemotherapy. The objective response rate was 29% with a median survival of 11.9 months among evaluable patients. The 1-year survival rate was 47%. Febrile neutropenia (17%) was the most common hematological toxicity associated with the regimen whereas grade 3 fatigue (4%) was the major nonhematological toxicity. Conclusions: The combination of carboplatin plus docetaxel is well tolerated and is effective for the treatment of patients with previously untreated advanced or metastatic non-small-cell lung cancer.