TREATMENT OF ACUTE MYELOGENOUS LEUKEMIA IN PATIENTS AGED 50-65 - IDARUBICIN IS MORE EFFECTIVE THAN ZORUBICIN FOR REMISSION INDUCTION AND PROLONGED DISEASE-FREE SURVIVAL CAN BE OBTAINED USING A UNIQUE CONSOLIDATION COURSE

From December 1987 to June 1992, 251 patients aged 50-65 with de novo acute myelogenous leukaemia (AML) were recruited to a multi-institutio nal randomized clinical trial. Induction therapy consisted of Ara-C (2 00 mg/m(2), continuous infusion, days 1-7) with either zorubicin (ZRB) (200 mg/m(2), i.v., days 1-4) or idarubicin (IDR) (8 mg/m(2), i.v., d ays 1-5). Consolidation therapy consisted of a single course of intens ive chemotherapy with high-dose Ara-C (3 g/m(2), 3 h infusion, q 12 h, days 1-4) and m-Amsa (100 mg/m(2)/d, i.v., days 5-7). The complete re mission (CR) rate was (73%) with Ara-C/IDR versus (60%) with Ara-C/ZRB (P = 0.033). In multivariate analysis, factors found to be significan t in predicting CR were normal karyotype and treatment with IDR. With a median follow-up of 73 months, the median disease-free survival (DFS ) duration of all CR patients and the probability of CR at 6 years wer e 17 months and 29%. In multivariate analysis the only factor associat ed with an increased DFS duration was a normal karyotype. The median e vent-free survival (EFS) duration for all evaluable patients and the m edian overall survival duration for all eligible patients were respect ively 7 and 12 months without any difference between induction arms. T he study shows that in patients aged 50-65 idarabicin is more effectiv e than zorubicin for remission induction. However, the type of anthrac ycline did not influence overall survival duration. Using a unique con solidation course, we observed a prolonged DFS which compares favourab ly with results obtained with more prolonged consolidation therapy or maintenance treatment.