Abstract
BACKGROUND: Platinum doublets are standard first-line treatment for stage IV non-small cell lung cancer (NSCLC) without targetable driver mutations. Oxaliplatin is more potent than cisplatin, requiring fewer DNA adducts to provide equivalent cytotoxicity. The objective of this study was to evaluate the efficacy and safety of oxaliplatin combined with docetaxel as a first-line treatment for stage IV NSCLC. METHODS: This was a prospective, single-center, phase II trial. Patients with chemotherapy-naive NSCLC received 60 mg/m(2) docetaxel (day 1) and 70 mg/m(2) oxaliplatin (day 2) every three weeks for up to six cycles. The primary endpoint was objective response rate (ORR), and the secondary endpoints were progression-free survival (PFS), overall survival (OS), and safety. Treatment response was evaluated according to Response Evaluation Criteria in Solid Tumors version 1.1. RESULTS: Thirty-three patients were enrolled and a response evaluation was available in 31 patients. There were 11 patients with a partial response, 15 with stable disease, and five with progressive disease. Two patients ceased further treatment after the first cycle of chemotherapy. Thus, the ORR was 33.3% in the 33 patients of the intention-to-treat population. Median PFS was 3.6 months (95% confidence interval [CI], 2.8-4.5), and median OS was 10.9 months (95% CI, 8.2-13.6). The most common hematologic toxicity was neutropenia. Grade 3-4 neutropenia occurred in 51.5% of patients. CONCLUSION: The results suggest that the combination of oxaliplatin and docetaxel is effective in patients with NSCLC with reasonable toxicity.