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Phase I and II Clinical and Pharmacological Study of 4-Demethoxydaunorubicin (Idarubicin) in Adult Patients with Acute Leukemia¹

Hematology/Lymphoma [A. N. D., Z. A. A., T. S. G., S. J. K., R. M., B. D. C.] and Developmental Chemotherapy [B. L-J., C. W. Y.] Services, Department of Medicine and the Clinical Pharmacology Laboratory [R. B., L. W.], Memorial Sloan-Kettering Cancer Center, New York, New York 10021, and the section of Medical Oncology, North Shore University Hospital, Manhasset, New York 11030 [D. B., P. S.]

Fifty-two adults treated previously with either acute leukemia (43 patients) or blastic-phase chronic myelogenous leukemia (nine patients) received 4-demethoxydaunorubicin (20 to 45 mg/sq m) i.v. over 2 to 3 days. Three of the ten patients with acute lymphocytic leukemia achieved a complete remission (CR) lasting 5 to 7 weeks. Five of the 28 patients with acute nonlymphocytic leukemia achieved a CR lasting 5 to 80 weeks. All remissions were induced with one course of treatment with a median time to CR of 28 days (range, 22 to 40 days). None of the patients with blastic chronic myelogenous leukemia or secondary leukemia achieved a CR. The drug was well tolerated; mucositis (36%), nausea and vomiting (35%), and hepatic dysfunction (26%) were the most common side effects. Pharmacokinetic observations on five patients demonstrated multiphasic clearance of 4-demethoxydaunorubicin and extensive formation and prolonged retention of 4-demethoxy-13-hydroxydaunorubicin; that metabolite accumulated in plasma on repeated daily dosing. 4-Demethoxydaunorubicin has sufficient antileukemic activity in both acute lymphocytic leukemia and acute nonlymphocytic leukemia to warrant a prospective comparison, in combination regimens, against the conventional anthracyclines, daunorubicin and/or doxorubicin.

¹ Supported in part by NIH Grant CA 05826 and by a grant from Farmitalia Carlo Erba.

² To whom requests for reprints should be addressed, at New York Medical College, Division of Neoplastic Diseases, Valhalla, NY 10595.

Received 12/12/83. Accepted 11/28/84.

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