High-dose liposomal daunorubicin and high-dose cytarabine combination in patients with refractory or relapsed acute myelogenous leukemia

Jorge Cortes*, Elihu Estey, Susan O'Brien, Francis Giles, Yu Shen, Charles Koller, Miloslav Beran, Deborah Thomas, Michael Keating, Hagop Kantarjian

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

42 Scopus citations

Abstract

BACKGROUND. Liposomal encapsulation of daunorubicin (DaunoXome, DNX; Nexstar Pharmaceutical, Boulder, CO) changes the pharmacology profile to increase delivery to tumor sites and decrease toxicity. The authors investigated the effect of daunorubicin in combination with ara-C in patients with refractory or recurring acute myelogenous leukemia (AML). PATIENTS AND METHODS. Sixty-two patients with refractory or recurring AML received escalating doses of daunorubicin of 75, 100, 125, or 135 mg/m2 daily for 3 days together with ara-C 1 g/m2 intravenous continuous infusion daily for 4 days. RESULTS. Eighteen patients (29%) achieved a complete remission (CR) and 7 (11%) a hematologic improvement (i.e., met all criteria for CR except for platelet count < 100 × 109/L) for an overall response rate of 40%. The dose-limiting toxicity was mucositis in 4 in 9 (44%) patients treated at the 150 mg/m2 dose level, but minimal at 125 mg/m2 (2 of 32, 6%) or 135 mg/m2 (1 of 13, 8%). Cardiotoxicity Grade 2 was observed in 4 patients (6%) and Grade 3 or higher in 4 patients (6%). The median CR duration was 63 weeks, and overall survival rate was 25 weeks, with 28% patients alive after 1 year. CONCLUSIONS. The combination of DNX (or liposomal daunorubicin) and ara-C has significant antileukemia activity with acceptable toxicity. Further studies are warranted to investigate the role of high-dose anthracyclines in frontline AML therapy.

Original languageEnglish (US)
Pages (from-to)7-14
Number of pages8
JournalCancer
Volume92
Issue number1
DOIs
StatePublished - Jul 1 2001

Keywords

  • Acute myeloid leukemia, liposomal daunorubicin, cytarabine, anthracyclines

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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