PHASE-II STUDY OF IRINOTECAN COMBINED WITH CISPLATIN IN PATIENTS WITHPREVIOUSLY UNTREATED SMALL-CELL LUNG-CANCER

Purpose: Irinotecan (CPT-11) is effective against small-cell lung canc er (SCLC) as monotherapy. Cisplatin is also a key drug against SCLC. W e conducted a phase II study of CPT-11 combined with cisplatin to eval uate the efficacy and toxicity of this regimen in patients with previo usly untreated SCLC. Patients and Methods: Seventy-five patients with previously untreated SCLC were enrolled onto the study CPT-11 60 mg/m( 2) wets administered intravenously on days 1, 8, and 15 in combination with cisplatin 60 mg/m(2) on day 1 every 28 days, Four courses of che motherapy followed by thoracic irradiation were given to patients with limited disease (LD) and six courses to patients with extensive disea se (ED). Results: The overall response rate was 84%, with a complete r esponse (CR) rate of 29%. Forty patients with LD achieved an overall r esponse rate of 83% and a CR rate of 30% and 35 patients with ED achie ved an overall response rate of 86% and a CR rate of 29%. The median r esponse duration was 8.0 months for LD patients and 6.6 months for ED patients, The median survival was 14.3 months for LD patients and 13.0 months for ED patients. The major grade 3 or 4 toxicities were neutro penia (77%), leukopenia (45%), diarrhea (19%), and anemia (39%), Two p atients died with concomitant neutropenia and diarrhea. Conclusion: Th is is a new active regimen for SCLC, especially ED-SCLC, with acceptab le toxicity. A phase III study that compares CPT-11/cisplatin with eto poside/cisplatin for ED-SCLC is now being conducted, (C) 1998 by Ameri can Society of Clinical Oncology.