Original Article

Clofarabine plus low-dose cytarabine followed by clofarabine plus low-dose cytarabine alternating with decitabine in acute myeloid leukemia frontline therapy for older patients

  1. Stefan Faderl MD1,†,*,
  2. Farhad Ravandi MD1,
  3. Xuelin Huang PhD2,
  4. Xuemei Wang MS2,
  5. Elias Jabbour MD1,
  6. Guillermo Garcia-Manero MD1,
  7. Tapan Kadia MD1,
  8. Alessandra Ferrajoli MD1,
  9. Marina Konopleva MD1,
  10. Gautam Borthakur MD1,
  11. Jan Burger MD1,
  12. Jennie Feliu RN1,
  13. Hagop M. Kantarjian MD1

Article first published online: 26 JAN 2012

DOI: 10.1002/cncr.27429

Issue

Cancer

Cancer

Volume 118, Issue 18, pages 4471–4477, 15 September 2012

Additional Information

How to Cite

Faderl, S., Ravandi, F., Huang, X., Wang, X., Jabbour, E., Garcia-Manero, G., Kadia, T., Ferrajoli, A., Konopleva, M., Borthakur, G., Burger, J., Feliu, J. and Kantarjian, H. M. (2012), Clofarabine plus low-dose cytarabine followed by clofarabine plus low-dose cytarabine alternating with decitabine in acute myeloid leukemia frontline therapy for older patients. Cancer, 118: 4471–4477. doi: 10.1002/cncr.27429

Author Information

  1. 1

    Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas

  2. 2

    Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, Texas

  1. †

    Fax: (713) 794-4297

*Department of Leukemia, Unit 428,The University of Texas MD Anderson Cancer Center, 1400 Holcombe Blvd., Houston, TX 77230

  1. †

    Fax: (713) 794-4297

Publication History

  1. Issue published online: 5 SEP 2012
  2. Article first published online: 26 JAN 2012
  3. Manuscript Accepted: 29 NOV 2011
  4. Manuscript Revised: 22 NOV 2011
  5. Manuscript Received: 6 OCT 2011

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Keywords:

  • acute myeloid leukemia;
  • clofarabine;
  • decitabine;
  • cytarabine;
  • induction therapy

Abstract

BACKGROUND:

Standard therapy for older patients with acute myeloid leukemia (AML) has a poor outcome. The authors have designed a combination of clofarabine plus low-dose cytarabine followed by a prolonged consolidation alternating with decitabine.

METHODS:

Sixty patients with a median age of 70 years (range, 60-81 years) with newly diagnosed AML were included. They received clofarabine 20 mg/m2 intravenously daily for 5 days plus cytarabine 20 mg subcutaneously twice daily for 10 days. Responding patients continued for up to 17 courses of consolidation therapy including decitabine.

RESULTS:

Forty of 59 evaluable patients responded (66%). Complete remission rate was 58%. Median relapse-free survival (RFS) was 14.1 (95% confidence interval [CI], 6.9 to not estimable), and median overall survival (OS) was 12.7 months (95% CI, 8.8 to not estimable). Median OS of responding patients (complete response [CR]/CR with platelet count <100 × 109/L) was 24.2 months (95% CI, 17 to not estimable). Compared with a historical group of patients who received clofarabine plus low-dose cytarabine with a shorter consolidation, RFS was not statistically different. Induction mortality was low (7% at 8 weeks) and toxicities manageable.

CONCLUSIONS:

Clofarabine plus low-dose cytarabine alternating with decitabine in consolidation is active in older patients with newly diagnosed AML. The benefits of a prolonged consolidation remain unproven. Cancer 2012. © 2012 American Cancer Society.

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