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Blood, 1 September 2008, Vol. 112, No. 5, pp. 1638-1645. Prepublished online as a Blood First Edition Paper on June 18, 2008; DOI 10.1182/blood-2007-11-124602. This Article Full Text (PDF) All Versions of this Article: blood-2007-11-124602v1 112/5/1638    most recent Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Rights and Permissions Citing Articles Citing Articles via HighWire Citing Articles via CrossRef Citing Articles via Google Scholar Google Scholar Articles by Faderl, S. Articles by Kantarjian, H. M Search for Related Content PubMed PubMed Citation Articles by Faderl, S. Articles by Kantarjian, H. M Social Bookmarking                   What's this?  Previous Article  |  Next Article  Submitted November 19, 2007 Accepted May 8, 2008 A randomized study of clofarabine versus clofarabine plus low-dose cytarabine as frontline therapy for patients age 60 years with acute myeloid leukemia and high-risk myelodysplastic syndrome Stefan Faderl*, Farhad Ravandi, Xuelin Huang, Guillermo Garcia-Manero, Alessandra Ferrajoli, Zeev Estrov, Gautam Borthakur, Srdan Verstovsek, Deborah A Thomas, Monica Kwari, and Hagop M Kantarjian Department of Leukemia, University of Texas M.D. Anderson Cancer Center, Houston, Texas, United States Department of Biostatistics, University of Texas M.D. Anderson Cancer Center, Houston, Texas, United States * Corresponding author; email: sfaderl{at}mdanderson.org. Clofarabine is a novel nucleoside analog with activity in adult AML. We previously reported the feasibility of clofarabine and cytarabine combinations in AML. Questions remain as to (1) the therapeutic advantage of this combination; and (2) the role of lower doses of clofarabine and cytarabine in older patients. We have therefore conducted an adaptively randomized study of lower dose clofarabine +/- low-dose cytarabine in previously untreated patients with AML 60 years. Patients received clofarabine 30 mg/m2 intravenously daily for 5 days +/- cytarabine 20 mg/m2 subcutaneously daily for 14 days as induction. Consolidation courses comprised 3 days of clofarabine +/- 7 days of cytarabine. Seventy patients were enrolled. The median age was 71 years (range 60 to 83 years). Sixteen patients received clofarabine and 54 the combination. Overall, 56% achieved complete remission (CR). CR rate was significantly higher with the combination (63% versus 31%, p= 0.025). Induction mortality was 19% with the combination versus 31% with clofarabine alone (p=0.276). The combination showed better event-free survival (7.1 months versus 1.7 months, p=.04), but not overall survival (11.4 months versus 5.8 months, p=.1). Clofarabine plus low dose cytarabine has a higher response rate than clofarabine alone with a comparable toxicity profile. CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this? This article has been cited by other articles: K. Bauer, N. Skoetz, C. Brillant, C. Herbst, I. Monsef, S. Kluge, and A. Engert Tenth Biannual Report of the Cochrane Haematological Malignancies Group--Focus on Acute Myeloid Leukemia J Natl Cancer Inst, October 21, 2009; 101(20): E1 - E1. [Full Text] [PDF] H. D. Klepin and L. Balducci Acute Myelogenous Leukemia in Older Adults Oncologist, March 1, 2009; 14(3): 222 - 232. [Abstract] [Full Text] [PDF] B. D. Shah and J. E. Lancet Frontline Treatment of Acute Myeloid Leukemia: Are We Making Progress? ASCO Educational Book, January 1, 2009; 2009(1): 372 - 377. [Abstract] [Full Text] [PDF]

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