CISPLATIN AND ETOPOSIDE VERSUS CYCLOPHOSPHAMIDE, EPIRUBICIN AND VINCRISTINE IN SMALL-CELL LUNG-CANCER - A RANDOMIZED STUDY

From September 1986 until December 1991, 139 patients with histologica lly-proven small cell lung cancer, age < 75 years, performance status > 40, absence of brain metastases and no previous treatment, were rand omised to receive either CEV cyclophosphamide 1000 mg/m(2) intravenous (i.v.), epirubicin 70 mg/m(2) i.v., vincristine 1.2 mg/m(2) i.v., eve ry 3 weeks or PE (cisplatin 20 mg/m(2) i.v. and etoposide 75 mg/m(2) i .v. for 5 consecutive days, every 3 weeks) for six cycles. After three cycles, responding patients received radiotherapy to the chest (45 Gy /15 sessions) and to the brain (30 Gy/10 sessions-only in patients wit h limited disease achieving complete remission). 3 patients were ineli gible. Patient characteristics included (CEV/PE) total number 66/70, m edian age 60/61 years, median performance status 80/80, extended disea se 33/48 cases (P = 0.04). In evaluable patients, 42/62 (67.7%) respon ded to CEV while 42/58 (72.4%) responded to PE (P = non-significant); respective complete response rates were 16.1 and 29.3% (P = non-signif icant) and respective complete response rates in patients with extende d disease were 9.4 and 28.9% (P = 0.03). Median survival was 10.5 mont hs, without significant differences in the two treatment arms, even af ter adjustment for stage. PE was less well tolerated than CEV. Althoug h PE is more active than CEV in certain subsets of patients, its appar ent inability to improve survival in this and in other studies questio ns its routine use in small cell lung cancer.