Phase II study of irinotecan combined with carboplatin in previously untreated non-small-cell lung cancer

Purpose: Irinotecan, a topoisomerase I inhibitor, is an effective agent for non-small-cell lung cancer (NSCLC). To determine the efficacy and toxicity of irinotecan and carboplatin, we conducted a phase II study in 61 patients with advanced NSCLC. Methods: Every 4 weeks, the patients received irinotecan 50 mg/m(2) ( days 1, 8 and 15) and carboplatin ( day 1) with a target AUC of 5 mg min/ml using the Chatelut formula. Results: All patients were evaluable for toxicity, and of 59 patients evaluable for response, 20 achieved a partial response and 26 showed no change. The overall response rate was 34% (95% confidence interval 23 - 48%). Grade 3 or 4 anemia, leukopenia, neutropenia, thrombocytopenia and diarrhea occurred in 32%, 32%, 60%, 25%, and 7%, respectively. The median survival time and 1-year, and 2-year survival rates were 10.0 months, 37.6%, and 15.2%, respectively. Conclusions: Irinotecan with carboplatin is effective for advanced NSCLC and safe.