Irinotecan plus carboplatin versus etoposide plus carboplatin in extensive disease small cell lung cancer: A randomized phase II trial

Abstract

7046 Background: Superiority of irinotecan/cisplatin combination over etoposide/cisplatin has recently been suggested in a small phase III study in patients with small cell lung cancer (SCLC). This trial compared the efficacy of irinotecan/carboplatin (PI) versus the frequently preferred standard regimen etoposide/carboplatin (PE) in SCLC. Methods: Chemotherapy-naive extensive disease SCLC patients were randomly assigned to receive carboplatin AUC 5 mg x min/mL either in comination with 50 mg/m2 of irinotecan on days 1, 8 and 15 (Arm A) or with etoposide 140mg/m2 days 1–3 (Arm B). In arm A treatment was repeated every 4 weeks, in arm B every 3 weeks. Response assessment was performed after cycles 2, 4 and 6 and every 3 months thereafter. Toxicity was assessed once weekly.Results: 74 patients were randomized. Today 59 patients are already evaluable for response assessment. CR/PR/SD/PD was observed in 10%/61%/6%/23% with PI and 0%/50%/11%/43% with PE. Significant differences in grade 3 and 4 toxicity was ob...