Daunorubicin was administered i.v. to patients with acute granulocytic leukemia in a variety of concurrently compared schedules of dosage. In the first design, 129 patients received 60 mg/sq m/day for scheduled courses of 3, 5, or 7 days. In one-half of the patients, drug was discontinued before the fifth scheduled dose. Five of 13 children sustained complete remission, as did 4 of 6 adults with promyelocytic leukemia. Complete remission rates of 16 to 29% were seen in the three regimens. Remissions lasted a median of 4 months irrespective of the type of antimetabolite maintenance treatment. Hematological toxicity was severe in two-thirds of patients, and cardiac toxicity was encountered in 8%. Capital alopecia occurred in nearly all patients.

A second study of 211 patients was then undertaken in which daunorubicin produced 34% complete remission in patients treated with 60 mg/sq m/day for 5 days, 20% in patients treated twice weekly, and 16% when treated weekly. In 39 previously untreated adults who received daunorubicin by the 5-day schedule, 43% reached complete remission. Hematological and cardiac toxicity were both less severe than previously, even in the 5-day schedule, perhaps attributable to greater experience with use of the drug.

Daunorubicin is an antibiotic of value equal or superior to that of any single drug in the treatment of acute myelocytic leukemia.

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This investigation was supported by USPHS research grants to the members of Acute Leukemia Group B: CA-10456 (O. J. G.), CA-05923 (R. L.), CA-04457 (J. C.), CA-02599 (R. R. E.), CA-07968 (R. T. S.), CA-08025 (V. B. R.), CA-03927 (M. R. C.), CA-05462 (F. H.).

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