Clofarabine and cytarabine combination as induction therapy for acute myeloid leukemia (AML) in patients 50 years of age or older

Stefan Faderl, Srdan Verstovsek, Jorge Cortes, Farhad Ravandi, Miloslav Beran, Guillermo Garcia-Manero, Alessandra Ferrajoli, Zeev Estrov, Susan O'Brien, Charles Koller, Francis J. Giles, William Wierda, Monica Kwari, Hagop M. Kantarjian

Research output: Contribution to journalArticle

125 Scopus citations

Abstract

Outcome of patients with acute myeloid leukemia (AML) who are older than 60 years of age remains unsatisfactory, with low remission rates and poor overall survival. We have previously established the activity of clofarabine plus cytarabine in AML relapse. We have now conducted a phase 2 study of clofarabine plus cytarabine in patients aged 50 years or older with previously untreated AML. Clofarabine was given at 40 mg/m2 as a 1-hour intravenous infusion for 5 days (days 2 to 6) followed 4 hours later by cytarabine at 1 g/m2/d as a 2-hour intravenous infusion for 5 days (days 1 to 5). Of 60 patients, 29 (48%) had secondary AML, 30 (50%) had abnormal karyotypes (monosomy 5 and/or 7 in 15 [25%]), and 11 (21%) showed FLT3 abnormalities. The overall response (OR) rate was 60% (52% CR, 8% CRp). Four patients (7%) died during induction. Adverse events were mainly grade 2 or lower and included diarrhea, nausea, vomiting, mucositis, skin reactions, liver test abnormalities, and infusion-related facial flushing and headaches. Myelosuppression was common. Clofarabine plus cytarabine has activity in adult AML, achieving a good CR rate. However, survival does not appear to be improved compared with other regimens. Modifications of this combination in AML therapy of older patients warrant further evaluation.

Original languageEnglish (US)
Pages (from-to)45-51
Number of pages7
JournalBlood
Volume108
Issue number1
DOIs
StatePublished - Jul 1 2006
Externally publishedYes

ASJC Scopus subject areas

  • Biochemistry
  • Immunology
  • Hematology
  • Cell Biology

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    Faderl, S., Verstovsek, S., Cortes, J., Ravandi, F., Beran, M., Garcia-Manero, G., Ferrajoli, A., Estrov, Z., O'Brien, S., Koller, C., Giles, F. J., Wierda, W., Kwari, M., & Kantarjian, H. M. (2006). Clofarabine and cytarabine combination as induction therapy for acute myeloid leukemia (AML) in patients 50 years of age or older. Blood, 108(1), 45-51. https://doi.org/10.1182/blood-2005-08-3294