Aclacinomycin-A in the induction treatment of childhood AML.

In the cooperative study AML-IGCI-84 27 children with AML (FAB M1 7X, M2 4X, M3 1X, M4 6X and M5 8X; 1 megakaryocytic leukemia) have been treated. The median initial white blood cell count was 18.0 G/l (range 1.8-1,350.0 G/l). 1 or 2 courses of induction therapy were used: I1 (aclacinomycin-A (ACLA-A), VP-16 and ARA-C) and I2 (daunorubicin (DNR), VP-16, and ARA-C). I2 was used only if bone marrow contained greater than 5% blast cells on day 21. I2 and consolidation treatment were identical with the current AML-BFM-83 protocol. 3 deaths before day 21 occurred (2 cerebral hemorrhages, 1 septicemia). 24 patients were evaluable for response, 20 (83.3%) achieved CR, 16 (66.7%) by I1, 4 after I2. 4 patients never reached CR, 3 of them had a PR after I1. M5 patients did badly (2 early deaths, 2 PR, 4 CR). All patients without CR after I1 received the whole AML-BFM-83 protocol. Comparison of the results of the 2 studies revealed a similar CR rate for I1 (our patients) and I2 (BFM data): 80.0% vs. 82.2% (calculated for patients who ever reached CR). CR was reached before consolidation in all our CR patients compared to 82.2% of BFM patients. Early CR may be of long term prognostic significance. Cardiotoxicity of induction may be reduced by substitution of DNR by ACLA-A.