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Immune modulation of minimal residual disease in early chronic phase chronic myelogenous leukemia: a randomized trial of frontline high-dose imatinib mesylate with or without pegylated interferon alpha-2b and granulocyte-macrophage colony-stimulating factor.

Author(s): Cortes J, Quintas-Cardama A, Jones D, Ravandi F, Garcia-Manero G, Verstovsek S, Koller C, Hiteshew J, Shan J, O'Brien S, Kantarjian H

Affiliation(s): Department of Leukemia, The University of Texas M. D. Anderson Cancer Center, Houston, Texas 77030, USA. jcortes@mdanderson.org

Publication date & source: 2011-02-01, Cancer., 117(3):572-80. Epub 2010 Sep 30.

Publication type: Clinical Trial, Phase II; Randomized Controlled Trial

BACKGROUND: Most patients with chronic myelogenous leukemia (CML) harbor residual disease, as evidenced by molecular techniques even after treatment with high-dose imatinib (ie, 800 mg/d). Interferon alpha (IFN alpha) is efficacious in CML likely due to its immunomodulatory properties, and is synergistic in vitro with imatinib and granulocyte macrophage-colony stimulating factor (GM-CSF). METHODS: A study was undertaken to determine whether adding pegylated (PEG) IFN alpha-2b and GM-CSF to high-dose imatinib may improve the complete molecular response rate in patients with CML in chronic phase. Ninety-four patients were treated with imatinib 800 mg/d for the first 6 months, then randomly assigned to continue high-dose imatinib alone (n = 49) or in combination with PEG IFN alpha-2b 0.5 mug/kg/wk and GM-CSF 125 mg/m(2) 3x weekly (n = 45). RESULTS: The median follow-up for all patients was 54 months (range, 7-70 months). There were no differences in the rates of complete cytogenetic response (87% vs 90%; P = 1.0), or of major (77% vs 77%; P = 1.0) or complete (11% vs 13%; P = 1.0) molecular response (on the international scale) at 12 months between the 2 arms, or at any time during the study. Adverse events led to PEG IFN alpha-2b discontinuation in all patients. CONCLUSIONS: The addition of PEG IFN alpha-2b and GM-CSF to high-dose imatinib therapy does not improve significantly the cytogenetic or molecular response rates compared with high-dose imatinib alone. The high dropout rate in the PEG IFN alpha-2b arm may have compromised its potential immunomodulatory benefit. Copyright (c) 2010 American Cancer Society.

Page last updated: 2011-12-09

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