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Daunorubicin in the Therapy of Acute Granulocytic Leukemia¹

Institut de Recherches sur les Leucemies, Paris, France [M. W., C. J., M. B., Je. B.]; Acute Leukemia Group B Operations Office, Buffalo, New York 14203 [O. J. G., J. F. H.]; State University of New York-Downstate Affiliated Hospitals, Brooklyn, New York 11238 [R. L.]; The National Cancer Institute-Baltimore Cancer Research Center, Baltimore, Maryland, 21211 [A. A. S., P. H. W.]; The Mount Sinai Hospital, New York, New York 10029 [J. C., B. H., L. W.]; Roswell Park Memorial Institute, Buffalo, New York 14203 [R. R. E., S. G.]; The Swiss Cooperative Group for Clinical Cancer Research, Bern, Switzerland [K. B.]; New York Hospital-Cornell Medical Center, New York, New York 10021 [R. T. S.]; Rhode Island Hospital, Providence, Rhode Island 02902 [V. B. R.]; Bowman Gray School of Medicine, Winston-Salem, North Carolina 27103 [M. R. C.]; Royal Victoria Hospital, Montreal, Quebec, Canada [L. L.]; Finsen Institute, Copenhagen, Denmark [N. I. N.]; Thomas Jefferson University Hospital, Philadelphia, Pennsylvania 19107 [F. H.]; and Walter Reed General Hospital, Washington, D. C. 20012 [Jo. B.]

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.

¹ 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.).

² Deceased.

³ To whom communications concerning this manuscript should be directed, at: Roswell Park Memorial Institute, 666 Elm Street, Buffalo, N. Y. 14203.

Received 9/12/72. Accepted 1/29/73.