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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.

Author(s): Faderl S, Ravandi F, Huang X, Garcia-Manero G, Ferrajoli A, Estrov Z, Borthakur G, Verstovsek S, Thomas DA, Kwari M, Kantarjian HM

Affiliation(s): Department of Leukemia, University of Texas M.D. Anderson Cancer Center, Houston, Texas, United States.

Publication date & source: 2008-06-18, Blood., [Epub ahead of print]

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/m(2) intravenously daily for 5 days +/- cytarabine 20 mg/m(2) 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.

Page last updated: 2008-06-22

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