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4-Demethoxydaunorubicin (Idarubicin) in Combination with 1-ß-D-Arabinofuranosylcytosine in the Treatment of Relapsed or Refractory Acute Leukemia¹

Hematology/Lymphoma and Developmental Chemotherapy Services, Department of Medicine [E.B., V.R., T.S.G., S.K., B.D.C.] and Clinical Pharmacology Laboratory [L.W., Y.-W.S., C.Y.], The Memorial Sloan-Kettering Cancer Center, and Cornell University Medical College, New York, New York 10021

We conducted a Phase I–II trial of 4-demethoxydaunorubicin (idarubicin, IDR) in combination with 1-ß-D-arabinofuranosylcytosine (ara-C) in 51 patients with relapsed or refractory acute nonlymphocytic leukemia, acute lymphocytic leukemia, or chronic myelogenous leukemia in blast crisis. Only 1 of 12 patients treated at the first dose level (idarubicin, 10 mg/m²/day for 3 days and ara-C, 25 mg/m² i.v. bolus followed by 200 mg/m² continuous infusion daily for 5 days) achieved aplasia and complete remission. The dose of idarubicin was subsequently increased to 10 mg/m²/day for 4 days with the ara-C dose held constant. Complete remission incidence for this dose schedule was: 7 of 31 patients with acute nonlymphocytic leukemia, 0 of 5 patients with acute lymphocytic leukemia, 0 of 1 patient with chronic myelogenous leukemia in blast crisis, and 1 of 2 patients with biphenotypic leukemia. Nonhematological toxicity included nausea, vomiting, mucositis, and abnormal liver function tests. Detailed pharmacological studies were performed to determine whether ara-C altered IDR metabolism or that of its main metabolite, 13-hydroxyidarubicinol or IDR clearance. A high degree of variability among patients was apparent and no consistent effect could be demonstrated. In summary, 9 of 37 patients (24%) with relapsed or refractory ANLL, including 1 patient with biphenotypic leukemia, achieved remission. We conclude that idarubicin in combination with ara-C is an active combination in patients with relapsed or refractory leukemia.

¹ Supported in part By NIH Grants CA 05826 and CA 08748 and by grants from Farmitalia Carlo Erba and Adria Laboratories.

² To whom requests for reprints should be addressed.

³ Present address: 773 North Main St., Meadville, PA 16335.

⁴ Present address: Department of Oncology, New York Medical College, Valhalla, NY.

⁵ Present address: 1 Cyanamid Plaza, Wayne, NJ 07470.

Received 1/14/88. Revised 9/14/88. Accepted 10/12/88.

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