IDARUBICIN TO INTENSIFY THE CONDITIONING REGIMENS OF AUTOLOGOUS BONE-MARROW TRANSPLANTATION FOR PATIENTS WITH ACUTE MYELOID-LEUKEMIA IN FIRST COMPLETE REMISSION

In an effort to reduce the relapse rate after unpurged autologous bone marrow transplantation (ABMT) in patients with acute myeloid leukemia (AML) in first complete remission (CR1), the, standard conditioning r egimens (cyclophosphamide/busulphan and cyclophosphamide/TBI) were int ensified by adding idarubicin, Seventeen patients received a continuou s infusion of 21 mg idarubicin/m(2)/day for 2 consecutive days in addi tion to the standard preparative regimen, Thirteen patients served as a historical control group. The 2-year disease-free survival (DFS) of 82% in the study group was significantly (P = 0.047) better compared t o 46% DFS in the control group. The relapse rate (RR) was also signifi cantly lower (7% vs 45%; P = 0.035) in the study group. The median tim e to reach a white cell count (WCC) of 0.5 x 10(9)/l was 20 days in th e study group vs 17 days (P=NS) in the control group. The median time until recovery of the platelet counts to 20 x 10(9)/l was 152 days in the study group vs 57 days (P = NS) in the control group, The hypolasi a in the study group resulted in a trend towards a higher need for tra nsfusions: a median number of 38 units of erythrocytes vs 23 units in the control group (P = NS) and 23 units of platelet vs 18 units in the control group (P = NS), This pilot study suggests that addition of id arubicin to the standard conditioning regimens may improve DFS and ove rall survival (OS) of patients with AML treated with ABMT in CR1, Thes e results should be confirmed in a prospective randomized study.