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

To determine the efficacy and toxicity of irinotecan combined with carboplatin, we conducted a phase II trial. Eligibility criteria were: chemotherapy-naive, small-cell lung cancer (SCLC), good performance status (PS:0-2), age <= 75 years, and adequate organ function. The patients' characteristics were: male/female 56/5; PS 0/1/2 = 19/38/4; median age ( range) 68 years(51-75 years); limited disease (LD)/extensive disease (ED) 27/34. The patients received irinotecan (50 mgm(-2)) on days 1, 8, and 15, and carboplatin (AUC 5, Chatelut formula) on day 1 every 4 weeks. In total, 61 patients were eligible and all were evaluated. In all, 31 patients were treated with four or more courses of chemotherapy. Of the patients, 17 showed a complete response (CR), 34 showed a partial response ( PR), nine had stable disease (SD), and one had progressive disease (PD). The overall response rate was 84% (95% confidence interval (CI), 72-91%; LD 89%, ED 79%) and the CR rate was 28% (95% CI, 17-41%; LD 37%, ED 21%). The median time to tumour progression was 6.1 (LD 6.4, ED 5.4) months. The medial survival time was 15.0 (LD 20.0, ED 9.7) months, and the 2-year and 5-year survival rates were 31.1% (LD 48.1%, ED 17.7%) and 9.5% (LD 11.1%, ED 5.9%), respectively. Grade 3 or 4 leucopenia, neutropenia, thrombocytopenia, anaemia, and diarrhoea occurred in 33, 74, 41, 39, and 13% of cases, respectively. In conclusion, the combination of irinotecan and carboplatin is an active and well-tolerated regimen in cases of SCLC.