ABSTRACT
The aim of this study is to evaluate the activity and toxicity of the combination docetaxel and irinotecan as first-line therapy for advanced non-small-cell lung cancer [NSCLC]. Twenty-two chemotherapy-naive patients with stage IIIB with pleural effusion or stage IV NSCLC received irinotecan 50 mg/m[2] on days 1, 8, and 15, and docetaxel 50 mg/m[2] on day 2, every 28 days until disease progression. Median follow-up was 10 months [range: 2-28 months]. The overall response rate was 36.4% [8/22 patients; 95% confidence interval: 16.8-56.0], with no complete responses. Median time to disease progression was 5 months [range: 1-24 months] and median overall survival was 10 months [range: 2-28]. Grade 3-4 diarrhea was observed in 2 patients [9.1%]. Grade 3-4 neutropenia occurred in 2 patients [9.1%]: 1 episode of febrile neutropenia in one patient, and 1 death due to neutropenic sepsis in another patient. One patient received transfusion for grade 4 anemia. Irinotecan showed a moderate response rate and overall survival of clinical interest. Diarrhea was the main toxicity. This regimen may be suitable for patients unable to tolerate cisplatin-based therapy, for elderly and/or for patients with poor performance status, and should be investigated in a larger trial