• Cancer · Apr 2006

    Randomized Controlled Trial Multicenter Study

    Decitabine improves patient outcomes in myelodysplastic syndromes: results of a phase III randomized study.

    • Hagop Kantarjian, Issa Jean-Pierre J JP, Craig S Rosenfeld, John M Bennett, Maher Albitar, John DiPersio, Virginia Klimek, James Slack, Carlos de Castro, Farhad Ravandi, Richard Helmer, Lanlan Shen, Stephen D Nimer, Richard Leavitt, Azra Raza, and Hussain Saba.
    • Department of Leukemia, University of Texas M. D. Anderson Cancer Center, Houston, Texas 77030, USA. hkantarj@mdanderson.org
    • Cancer. 2006 Apr 15; 106 (8): 1794-803.

    BackgroundAberrant DNA methylation, which results in leukemogenesis, is frequent in patients with myelodysplastic syndromes (MDS) and is a potential target for pharmacologic therapy. Decitabine indirectly depletes methylcytosine and causes hypomethylation of target gene promoters.MethodsA total of 170 patients with MDS were randomized to receive either decitabine at a dose of 15 mg/m2 given intravenously over 3 hours every 8 hours for 3 days (at a dose of 135 mg/m2 per course) and repeated every 6 weeks, or best supportive care. Response was assessed using the International Working Group criteria and required that response criteria be met for at least 8 weeks.ResultsPatients who were treated with decitabine achieved a significantly higher overall response rate (17%), including 9% complete responses, compared with supportive care (0%) (P < .001). An additional 12 patients who were treated with decitabine (13%) achieved hematologic improvement. Responses were durable (median, 10.3 mos) and were associated with transfusion independence. Patients treated with decitabine had a trend toward a longer median time to acute myelogenous leukemia (AML) progression or death compared with patients who received supportive care alone (all patients, 12.1 mos vs. 7.8 mos [P = 0.16]; those with International Prognostic Scoring System intermediate-2/high-risk disease, 12.0 mos vs. 6.8 mos [P = 0.03]; those with de novo disease, 12.6 mos vs. 9.4 mos [P = 0.04]; and treatment-naive patients, 12.3 mos vs. 7.3 mos [P = 0.08]).ConclusionsDecitabine was found to be clinically effective in the treatment of patients with MDS, provided durable responses, and improved time to AML transformation or death. The duration of decitabine therapy may improve these results further.2006 American Cancer Society

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