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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 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 Citation Map 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. Related Collections Neoplasia Free Research Articles Clinical Trials and Observations Social Bookmarking                   What's this?  Previous Article  |  Table of Contents  |  Next Article  CLINICAL TRIALS AND OBSERVATIONS A randomized study of clofarabine versus clofarabine plus low-dose cytarabine as front-line therapy for patients aged 60 years and older with acute myeloid leukemia and high-risk myelodysplastic syndrome Stefan Faderl1, Farhad Ravandi1, Xuelin Huang2, Guillermo Garcia-Manero1, Alessandra Ferrajoli1, Zeev Estrov1, Gautam Borthakur1, Srdan Verstovsek1, Deborah A. Thomas1, Monica Kwari1, and Hagop M. Kantarjian1 Departments of1 Leukemia and 2 Biostatistics, University of Texas M. D. Anderson Cancer Center, Houston 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 conducted an adaptively randomized study of lower-dose clofarabine with or without low-dose cytarabine in previously untreated patients with AML aged 60 years and older. Patients received 30 mg/m2 clofarabine intravenously daily for 5 days with or without 20 mg/m2 cytarabine subcutaneously daily for 14 days as induction. Consolidation consisted of 3 days of clofarabine with or without 7 days of cytarabine. Seventy patients were enrolled. The median age was 71 years (range, 60-83 years). Sixteen patients received clofarabine and 54 the combination. Overall, 56% achieved complete remission (CR). CR rate was significantly higher with the combination (63% vs 31%; P = .025). Induction mortality was 19% with the combination versus 31% with clofarabine alone (P = .276). The combination showed better event-free survival (7.1 months vs 1.7 months; P = .04), but not overall survival (11.4 months vs 5.8 months; P = .1). Clofarabine plus low-dose cytarabine has a higher response rate than clofarabine alone with comparable toxicity. This trial is registered at www.clinicaltrials.gov as no. NCT00088218 [ClinicalTrials.gov] . CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this? This article has been cited by other articles: 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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