Mature Results of a Phase II Trial of Gemcitabine/Paclitaxel Given Every 2 Weeks in Patients with Advanced Non–Small-Cell Lung Cancer

PurposeThis phase II study evaluated the efficacy and toxicity of gemcitabine/paclitaxel given every 2 weeks in patients with advanced-stage non–small-cell lung cancer. Treatment with 1 previous chemotherapy regimen was allowed. Patients received gemcitabine 3000 mg/m2 intravenously over 30 minutes and paclitaxel 150 mg/m2 over 3 hours every 2 weeks.Patients and MethodsForty-five patients were enrolled: 31 patients were chemotherapy naive and 14 patients were previously treated. The median age was 61 years, and the majority of patients had adenocarcinoma and stage IV disease. The minimum follow-up was 4.5 years. The response rate was 27% for all 45 patients and 32% for the 38 patients who were response evaluable.ResultsThe response rate was 26% (31% response evaluable) for the patients who were chemotherapy-naive and 29% (33% response evaluable) for the patients who were previously treated. For the entire group, the median time to progression was 3.3 months; median overall survival was 9.4 months, and the 1-year and 2-year survival rates were 38% and 13%, respectively. The overall survival and time to progression durations were not significantly different between patients who were chemotherapy-naive and patients who were previously treated. The toxicities associated with treatment were minimal, with only 1 episode of grade 4 neutropenia and a low incidence of significant nonhematologic toxicity.ConclusionGemcitabine/paclitaxel is active in the treatment of non–smallcell lung cancer. The every-2-week schedule is likely to be responsible for the low level of toxicity seen with this regimen and could be used as the basis for the addition of other agents in future clinical trials.