@article{3085111, title = "A multicenter phase II study of the combination of irinotecan and gemcitabine in previously treated patients with small-cell lung cancer", author = "Agelaki, S and Syrigos, K and Christophylakis, C and Boukovinas, J and and Varthalitis, J and Pavlakou, G and Athanasiadis, A and Kouroussis, C and and Vardakis, N and Maltezakis, G and Milaki, G and Georgoulias, V and Lung and Canc Subgroup HORG", journal = "DIAGNOSTIC ONCOLOGY", year = "2004", volume = "66", number = "3", pages = "192-196", publisher = "Karger", doi = "10.1159/000077994", keywords = "irinotecan (CPT-11); gemcitabine; pretreated small-cell lung cancer", abstract = "Objective: To evaluate efficacy and toxicity of the combination of irinotecan and gemcitabine in pretreated patients having small-cell lung cancer. Patients and Methods: Thirty-one patients ( median age 60 years, performance status 0-1 in 87% and 2 in 13% of the patients) with limited or extensive-stage disease, refractory or relapsing after at least one prior chemotherapy regimen, received gemcitabine 1,000 mg/m(2) on days 1 and 8 and irinotecan 300 mg/m(2) on day 8, every 21 days. Sixteen (52%) patients had sensitive and 15 (48%) refractory disease. Fifteen patients (48%) had received 62 prior regimens. Results: All patients were evaluable for toxicity and 26 for response analysis. A median of three ( range 1-6) cycles per patient was administered. Three partial responses were documented for an overall response rate of 10% (95% CI 0.73-20.09), and disease stabilization was obtained in 7 patients (22%; intention-to-treat analysis). Two of the responders had refractory, and 1 had sensitive disease. The median time to progression was 4.5 months, the median duration of responses was 2.5 months, and the median survival time was 6 months. Grade 3-4 ( WHO) neutropenia was observed in 9 patients (29%), grade 3-4 thrombocytopenia in 4 (13%), and grade 3-4 diahrrea in 3 patients (10%). Three patients experienced febrile neutropenia. No toxic deaths occurred. Conclusions: The combination showed modest activity in this patient group with a poor prognosis. Thus we believe it merits further investigation in the treatment of patients with small-cell lung cancer who have failed one prior chemotherapy regimen. Copyright (C) 2004 S. Karger AG, Basel." }