A Comparison of Gemcitabine in Two Doses for Stage III or IV Non-small Cell Lung Cancer: a Multi-Institutional Phase II Study

Purpose: Since the combination of cisplatin plus gemcitabine (CG) had a significant survival advantage for the treatment of patients with chemotherapynave advanced or metastatic non-small cell lung cancer (NSCLC), CG combination have been evaluated with different schedules. However, the best schedule is still unclear. We designed to compare the efficacy and toxicity of CG combination chemotherapy in two different doses of gemcitabine (1,000 or 1,250 mg/m 2 3-weekly). Materials and Methods: We randomized patients with stage III or IV NSCLC into either gemcitabine 1,250 mg/m 2 or gemcitabine 1,000 mg/m 2 . Patients received cisplatin 60 mg/m 2 intravenously on day1 of each 3-week cycle. Gemcitabine was administered intravenously on days 1 and 8 of each 3-week cycle. Results: From April 2002 until July 2004, 125 patients were enrolled from four university hospitals (55 patients in the gemcitabine 1,000 mg/m 2 arm and 70 patients in the gemcitabine 1,250 mg/m 2 arm). Response rates were not significantly different in both arms (56.4% vs. 55.7%). However, grade 3 neutropenia was significantly lower in gemcitabine 1,000 mg/m 2 arm compared to gemcitabine 1,250 mg/m 2 arm (11.0% vs.