Treatment of Acute Myeloid Leukemia (AML) in Adults 50 to 70 Years, Study of Two Anthracyclines and the Interest of Maintenance Treatment With Interleukin 2

Patients from 50 to 70 years with de novo AML were randomized to receive ARAC 200 mg / m² / d IV x 7 d with either DNR 80 mg/m²/dx3d (arm 1) or IDA 12 mg / m²/d x 3 d (arm 2) or 4 d (arm 3). The pts received a failing course of remedial Mitoxantrone involving x 2 and j ARAC 1g / m 2 x / d x 4 days The pts in CR then received 2 courses of consolidation with, according to initial randomization either DNR 80 mg / m² IDA 12 mg / sqm x 1 d (1st treatment) or 2 d (2nd treatment) and ARAC 1 gsm 2/jx x 4 days The pts in CR were then randomized persistent IL2 (5 million IU / m² x 5 d / month in SC for 12 months) or no treatment.

Inclusion criteria

• Patient from 50 to 70 years
• AML de Novo
• No prior therapy for AML
• Absence of severe infection (WHO grade greater than 2), independent of the AML
• Cardiac function determined by radionucleotide or echography within normal limits.
• total bilirubin less than or equal 2N and Serum creatinin less than or equal 2N
• ECOG performance status 0 to 3
• Signed informed consent.

Exclusion criteria

• M3-AML
• history of neoplasia treated by radiotherapy or chemotherapy
• Myelodysplasia diagnosed more than 6 months before the diagnosis of AML
• Prior treatment for AML
• Uncontrolled infection
• Other active malignancy
• Patient unable to undergo regular surveillance