A PHASE-II TRIAL OF COMBINATION OF CPT-11 AND CISPLATIN FOR ADVANCED NON-SMALL-CELL LUNG-CANCER

A phase I trial of the combination of irinotecan (CPT-11) with cisplat in in advanced non-small cell lung cancer (NSCLC) showed a very promis ing response rate of 54% in previously untreated NSCLC patients, This study was conducted to confirm the activity and toxicities of CPT-11 a nd cisplatin combination for previously untreated NSCLC in a multi-ins titutional phase II study. Seventy patients with stage IIIB or IV NSCL C received CPT-11 60 mg m(-2) intravenously (IV) on days 1, 8 and 15, and cisplatin 80 mg m(-2) (IV) on day 1 every 4 weeks. Assessments wer e made of response, survival and toxicities. Sixty-nine were eligible, and evaluable for toxicities and survival, and 64 patients evaluable for response, Thirty-three patients (52%; 95% confidence interval 39-6 4%) achieved an objective response, with one complete response (2%) an d 32 partial responses (50%), The median duration of response was 19 w eeks and the overall median survival time was 44 weeks. The 1-year sur vival rate was 33%. The major toxic effects were leucopenia and diarrh oea. Grade 3 or 4 leucopenia, neutropenia, and diarrhoea occurred in 3 2 patients (46%), 53 patients (80%), and 13 patients (19%) respectivel y A combination of CPT-11 and cisplatin is very effective against non- small-cell lung cancer with acceptable toxicities.