Japanese experience with second-line chemotherapy with low-dose (60 mg/m²) docetaxel in patients with advanced non-small-cell lung cancer

Abstract.

Purpose: To assess the efficacy and toxicity of relatively low-dose docetaxel (60 mg/m²) for previously treated advanced non-small-cell lung cancer (NSCLC). Patients and methods: Patients with advanced (clinical stage IIIA–IV) NSCLC who had previously undergone at least one series of chemotherapy were enrolled. Previous paclitaxel use was allowed, but docetaxel was not. Docetaxel was administered at an initial dose of 60 mg/m² intravenously on day 1 over 90 min every 3 weeks. Results: From June 1997 to November 1999, 22 patients were entered into this study. The total number of cycles delivered to 22 patients was 53, with a median per patient of 2. Four patients achieved a partial response (PR), and the overall response rate was 18.2% (95% confidence interval 5.1–40.3%). The median time to progression was 13.7 weeks. The median survival time was 7.8 months, and the 1-year survival rate was 25%. About 73% of patients experienced grade 3 or 4 neutropenia. Neutropenic fever was observed in four patients (18%). Non-hematologic toxicities were generally mild. No treatment-related deaths occurred. Conclusions: Although the validity of the results of this study is limited due to the small and monoracial study population examined, low-dose (60 mg/m²) docetaxel for previously treated advanced NSCLC appears to yield antitumor activity and survival benefit comparable to those obtained with the conventional dose (100 mg/m²).