Daunorubicin was used as the single chemotherapeutic agent in 96 children with acute lymphoblastic leukemia resistant to other agents. On a randomized basis, the doses used were 30, 45, or 60 mg/sq m daily for 5 days, with provision for a second course in those who failed to respond. The marrow remission rates were, respectively, 24, 32, and 41% when the three randomization groups were analyzed. When only those who received a full course of drug during the first 5 days of study were examined, the remission rates at both 45 (43%) and 60 mg/sq m (38%) were superior to that at 30 mg/sq m (18%). The median time lapse from the first dose to remission was 22 days, with the earliest remission occurring in 11 days. The remissions were short. The median was 66 days (range, 8 to 419 days) in this group of patients. The primary toxicity is hematological with severe leukopenia, thrombocytopenia, and bone marrow aplasia. Cardiac toxicity also occurred. This cytotoxic antibiotic has definite antileukemic properties. Daunorubicin may find ultimate use as a component in combination therapy for remission induction of acute lymphoblastic leukemia.
This study was supported by Grants CA 07757 (B. J.), CA 02599 (J. F. H., L. F. S.), CA 05923 (A. R. M., S. L. L.), CA 04457 (J. C., A. R.), CA 08080 (F. K.), CA 05462 (F. I. H.), CA 03927 (R. B. P.), CA 04646 (E. O. B.), CA 03735 (J. H. M.), CA 11028 (A. S.), CA 08025 (M. M. A.), and CA 04326 (R. J. F.) from the National Cancer Institute, USPHS, and Dominion Provincial Grant 6-08 (L. C.). Presented in part at the meeting of the American Society of Hematology, December 5, 1967, Toronto, Ontario, Canada.