A Phase I/II Study Comparing Regimen Schedules of Gemcitabine and Docetaxel in Japanese Patients with Stage IIIB/IV Non-small Cell Lung Cancer

Objective: Gemcitabine and docetaxel are non-platinum agents with activity in non-small cell lung cancer (NSCLC). This study was conducted to determine and evaluate the recommended regimen of gemcitabine–docetaxel and evaluated its efficacy and safety in chemonaive Japanese NSCLC patients. Methods: In phase I, patients with stage IIIB/IV NSCLC were randomized and received either gemcitabine on days 1 and 8 plus docetaxel on day 1 or gemcitabine on days 1 and 8 plus docetaxel on day 8. The recommended regimen was the dose level preceding the maximum tolerated dose; once determined, patients were enrolled in phase II. Efficacy and toxicity were evaluated in all patients. Results: Twenty-five patients were enrolled in phase I and six patients were given the recommended regimen; gemcitabine 1000 mg/m2 on days 1 and 8 plus docetaxel 50 mg/m2 on day 8. An additional 34 patients were enrolled into phase II and administered with the recommended regimen. The response rate was 32.2% [95% confidence interval (CI) 20.6–45.6%] overall and 30.0% (95% CI 16.6–46.5%) in patients with the recommended regimen (40 patients). Although grade 3 interstitial pneumonia was observed in two patients (5.0%) who received the recommended regimen, both recovered shortly after steroid treatment. No unexpected events were observed throughout this study. Conclusions: Gemcitabine 1000 mg/m2 on days 1 and 8 plus docetaxel 50 mg/m2 on day 8 has comparable efficacy and more tolerable toxicities than previously reported platinum-based regimens. These results should be verified by a phase III study.