4-Demethoxydaunonibicin (Idarubicin) in Combination with 1-β-D-Arabinofuranosylcytosine in the Treatment of Relapsed or Refractory Acute Leukemia

Ellin Berman, Virginia Raymond, Aiman Daghestani, Zalmen A. Arlin, Timothy S. Gee, Sanford Kempin, Counce Hancock, Linda Williams, Yee Wan Stevens, Bayard D. Clarkson, Charles Young

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21 Scopus citations

Abstract

We conducted a Phase I—II trial of 4-demethoxydaunorubicin (idarub-icin, IDR) in combination with 1 -β-D-arabinofuranosy lcytosine (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 nonlym-phocytic 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-hydroxyida-rubicinol 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.

Original languageEnglish
Pages (from-to)477-481
Number of pages5
JournalCancer Research
Volume49
Issue number2
StatePublished - 15 Jan 1989
Externally publishedYes

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