Front-line treatment of advanced non-small cell lung cancer with irinotecan and docetaxel: A multicentre phase II study

Purpose : To evaluate the efficacy and tolerance of the irinotecan plus docetaxel combination in patients with advanced non-small cell lung cancer (NSCLC). Patients and methods : Thirty-nine chemotherapy-naive patients with advanced NSCLC were treated with irinotecan 200mg/m(2) followed by docetaxel 80mg/m(2) intravenously on day 1 with granulocyte colony-stimulating factor (150 mu g/m(2)) Support from day 2 to 9. Treatment was repeated every 3 weeks. Results : A partial response was achieved in 9 (23%; 95% confidence interval 9.85-36.3%) patients; stable and progressive disease were observed in 10 (25.6%) and 20 (51.4%) patients, respectively. The median duration of response was 7.1 months and the median time to tumor progression 3 months. The median survival time was 10.8 months and the 1-year survival 42.2%. Four (10.3%) patients developed grade 4 neutropenia and all but one were complicated with fever; there was no treatment-related death. Nine (23.1%) patients developed grade 3 or 4 diarrhea while grade 2 or 3 fatigue occurred in nine (23.1%), and grade 3 mucositis in two (2.6%). Conclusion : The combination of irinotecan/docetaxel is a relatively active non-ptatinum-based chemotherapy regimen with manageable toxicity, which could be given in an outpatient basis; this regimen merits to be further studied in order to improve its tolerance and evaluate its clinical relevance in patients who can not tolerate platinum-based doublets. (c) 2005 Elsevier Ireland Ltd. All rights reserved.