91 Delivered dose intensity with an induction chemotherapy (CT) by ifosfamide, etoposide and anthracyclin for patients (PTS) with small cell lung cancer (SCLC): A report by the european lung cancer working party

Abstract

We conducted a randomized trial comparing a maintenance CT versus a simple follow-up in SCLC pts having achieved a complete response after 6 induction CT courses, given at theoretical 3 week intervals, with ifosfamide (IFO) (1.5 mg/m2 dl–3, iv), etoposide (VP) (80 mg/m2 dl–3, iv) and, with a random allocation, epirubicin (EPI) (60 mg/m2 d1) -IVE- versus adriamycin (ADR) (45 mg/m2 d1) -IVA- in a first set of pts or epirubicin (60 mg/m2 dl) -IVE60- versus epirubicin (90 mg/m2) -IVE90- in a second set of pts. The mean absolute delivered dose intensities (ADI) of the anthracyclin in mg/m2/week were as following: First set Second set IVE IVA IVE60 IVE90 At 3 courses n = 47 n = 47 n = 55 n = 54 18.1 13.1 16.4 23.1 At 6 courses n = 40 n = 37 n = 41 n = 38 17.6 13.0 16.1 23.3 Each theoretical schedule was feasible as by Mann-Whitney tests, the distributions of the relative intensities were not statistically different. Comparisons of response rates at 3 courses and of overall survival curves by treatment arm were not statistically different in the 2 series of pts and remained not significant when stratified by relative global dose intensity. However, in responders to the induction CT, using a Cox model, administration of a maintenance CT as well as an increased ADI of the anthracyclin drug -with the equivalence of 60 mg epirubicin to 45 mg adriamycin- (P = 0.03) had a positive impact on survival in both series of pts suggesting a potential benefit of a prolonged treatment when adjusting for the intensity of the first regimen.