Treatment of adult acute myeloid leukemia: Results of 7-year clinical trials

Aim. Comparison of effectiveness of induction regimens varying in intensity and maintenance variants in patients with acute myeloid leukemia (AML) inc luded in a randomised multicenter trial. Materials and methods. Clinical trial 1 enrolled 185 AML patients. Vepezide -free induction was used in 85 patients (group 1), induction with vepezide - in 99 patients (group 2). 223 AML patients enter ed trial 2. Of them 37 p atients were treated for 3 years 7+3 with daumorubicin in the dose 45 mg/m( 2) in the induction phase (group 1), 85 and 101 patients received 7+3 with daunorubicin for a year in the dose 45 mg/m(2) and 60 mg/m(2), respectively , (group 2 and 3). Results. For group 1 in trial 1 the, remission rate, early lethality, resis tance were, respectively, 60, 20 and 20%, respectively. For group 2 in tria l 1 - 66, 22 and 12%, respectively. 5-year recurrence-free survival reached 32 and 37% for group 1 and 2 respectively. For trial 2 relevant figures ma de up 75.5, 16.2, 8.1% for group 1; 60, 17.6 and 22.4% for group 2; 63, 20. 8 and 16% for group 3, respectively. The 3.5-year recurrence-free survival in groups 1, 2 and 3, was 16, 46 and 50%, respectively. For both trials, th e differences between the groups were insignificant. Conclusion. The results evidence that the treatment can be shorter (not 3 b ut 1 year or even 6 months), the induction more intensive (the dose of anth racycline antibiotics can be elevated up to 60 mg/m(2) without a rise in ea rly lethality).