PHASE-II STUDY OF PROLONGED ORAL ETOPOSIDE IN COMBINATION WITH INTRAVENOUS CISPLATIN IN ADVANCED NONSMALL CELL LUNG-CANCER

The objectives of the study were to evaluate the combination of cispla tin and prolonged oral etoposide for response rate, survival, and toxi city. The treatment regimen consisted of etoposide (50 mg/m(2)/day) p. o. for 21 consecutive days and cisplatin (100 mg/m(2)) i.v. on day 1 e very 28 days for up to six courses. Patients with Stage IIIB or IV non -small cell lung cancer who had not received prior chemotherapy and ha d an ECOG performance status of 0-2 were eligible if they had normal b one marrow, liver and renal functions. Patients were followed weekly f or toxicity including complete blood counts. The total number of patie nts entered in the study was 60, of whom 56 were male and four female, 40 white and 20 African Americans. Median age was 64 years (range, 39 -77). Performance status 0, 1, and 2 was present in five, 39, and 16 p atients, respectively. Fourteen patients had Stage IIIB and 46 Stage I V disease. A total of 142 treatment courses were administered (median 2, range 1-6). Three patients had a complete response and 19 patients had a partial response for an objective response rate of 37% (95% conf idence interval, 31-43%). Median survival was 5 months (range, 1-39+). Neutropenia was the major toxicity with Grade 4 occurring in 25 patie nts after the first course. The following percent of patients experien ced severe or life-threatening hematologic toxicity (Grade 3 and 4 com bined) over all courses: leukopenia, 73%; neutropenia, 73%; anemia, 42 %; and thrombocytopenia, 37%. Three patients died of neutropenic sepsi s. This regimen of prolonged etoposide with cisplatin is active in adv anced non-small cell lung cancer, but has substantial toxicity.