A phase II study of carboplatin and irinotecan in extensive stage small-cell lung cancer.

Objectives: Our study set out to determine the antitumor efficacy of carboplatin and irinotecan as assessed by response rate in persons with chemotherapy-naive extensive-disease, small-cell lung cancer (ED-SCLC). Secondary objectives included progression-free survival (PFS), overall survival, and toxicity findings.
Methods: Patients with previously untreated ED-SCLC, Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2, life expectancy ≥ 3 months, and adequate organ function were eligible. Patients were treated with carboplatin AUC 5 intravenously over 30-60 minutes on day 1, followed by CPT-11(irinotecan) 50 mg/m(2) intravenously over 30-90 minutes on days 1 and 8 every 3 weeks for 4-6 cycles at the discretion of the treating physician.
Results: Fifty-six patients were enrolled, and 50 patients were eligible. The median age of patients was 60.1 years. The most common toxicities were neutropenia, thrombocytopenia, nausea/vomiting, and dehydration. The overall response rate was 58%. Median PFS was 5.3 months, median overall survival was 9.7 months, and 1-year overall survival was 28.7%.
Conclusions: Carboplatin and irinotecan is a safe and reasonable combination for the treatment of patients with ED-SCLC.
(Copyright © 2011 Elsevier Inc. All rights reserved.)