PHASE-II TRIAL OF COMBINATION CHEMOTHERAPY WITH CISPLATIN, CARBOPLATIN AND ETOPOSIDE IN STAGE IIIB AND STAGE-IV SMALL-CELL LUNG-CANCER

Purpose: A phase II trial combining cisplatin, carboplatin and etoposi de was conducted in previously untreated patients with stage IIIB and IV small-cell lung cancer, in an attempt to increase response rates an d prolong survival. Methods: Previously untreated patients with small- cell lung cancer, with measurable disease, aged less than or equal to 72 years, performance status less than or equal to 2, and adequate hem atologic, hepatic and renal function were enrolled in the study. They were treated with 80 mg/m(2) cisplatin on day 1, 100 mg/m(2) carboplat in on days 2, 3 and 8, and 50 mg/m(2) etoposide on days 1, 2, 3 and 8. Results: A total of 46 patients (20 with stage IIIB and 26 with stage IV disease) were enrolled in the study. A total of 186 courses of che motherapy were given, and the dose was reduced in 27 courses (15%). Th e chemotherapy was repeated for four or more courses in 30 patients. T here were 10 complete responses and 32 partial responses, for a total response rate of 91% (95% confidence interval, 79% to 98%). The median survival time and 2-year survival rates were 18 months and 22% for st age IIIB disease, and 14 months and 15% for stage IV disease. Major si de effects were hematologic: leukopenia! anemia, and thrombocytopenia of grade 3 or more occurred in 45%, 46%, and 43% of patients, respecti vely. Conclusions: The three-drug regimen of cisplatin, carboplatin an d etoposide is feasible and active against small-cell lung cancer.