SEARCH:   Advanced

Blood, 18 June 2009, Vol. 113, No. 25, pp. 6322-6329. Prepublished online as a Blood First Edition Paper on April 15, 2009; DOI 10.1182/blood-2008-11-186817. This Article Full Text Full Text (PDF) All Versions of this Article: blood-2008-11-186817v1 113/25/6322    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 CrossRef Google Scholar Articles by Kantarjian, H. Articles by Tallman, M. S. PubMed PubMed Citation Articles by Kantarjian, H. Articles by Tallman, M. S. Related Collections Free Research Articles Myeloid Neoplasia Clinical Trials and Observations Social Bookmarking                   What's this?  Previous Article  |  Table of Contents  |  Next Article  CLINICAL TRIALS AND OBSERVATIONS Phase 3 study of dasatinib 140 mg once daily versus 70 mg twice daily in patients with chronic myeloid leukemia in accelerated phase resistant or intolerant to imatinib: 15-month median follow-up Hagop Kantarjian1, Jorge Cortes1, Dong-Wook Kim2, Pedro Dorlhiac-Llacer3, Ricardo Pasquini4, John DiPersio5, Martin C. Müller6, Jerald P. Radich7, H. Jean Khoury8, Nina Khoroshko9, M. Brigid Bradley-Garelik10, Chao Zhu10, and Martin S. Tallman11 1 M. D. Anderson Cancer Center, Houston, TX; 2 St Mary's Hospital, Seoul, South Korea; 3 Hospital das Clinicas, Sao Paulo, Brazil; 4 Hospital De Clinicas De Curitiba, Curitiba, Brazil; 5 Washington University School of Medicine, St Louis, MO; 6 Medizinische Fakultaet Mannheim, University of Heidelberg, Heidelberg, Germany; 7 Fred Hutchinson Cancer Research Center, Seattle, WA; 8 Emory University School of Medicine, Atlanta, GA; 9 National Research Hematology Center, Moscow, Russian Federation; 10 Bristol-Myers Squibb, Wallingford, CT; and 11 Northwestern University Feinberg School of Medicine, Chicago, IL Dasatinib is the most potent BCR-ABL inhibitor, with 325-fold higher potency than imatinib against unmutated BCR-ABL in vitro. Studies have demonstrated the benefits of dasatinib 70 mg twice daily in patients with accelerated-phase chronic myeloid leukemia intolerant or resistant to imatinib. A phase 3 study compared the efficacy and safety of dasatinib 140 mg once daily with the current twice-daily regimen. Here, results from the subgroup with accelerated-phase chronic myeloid leukemia (n = 317) with a median follow-up of 15 months (treatment duration, 0.03-31.15 months) are reported. Among patients randomized to once-daily (n = 158) or twice-daily (n = 159) treatment, rates of major hematologic and cytogenetic responses were comparable (major hematologic response, 66% vs 68%; major cytogenetic response, 39% vs 43%, respectively). Estimated progression-free survival rates at 24 months were 51% and 55%, whereas overall survival rates were 63% versus 72%. Once-daily treatment was associated with an improved safety profile. In particular, significantly fewer patients in the once-daily group experienced a pleural effusion (all grades, 20% vs 39% P < .001). These results demonstrate that dasatinib 140 mg once daily has similar efficacy to dasatinib 70 mg twice daily but with an improved safety profile. This trial is registered at www.clinicaltrials.gov as #CA180-035. CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this?

	Copyright © 2009 by American Society of Hematology         Online ISSN: 1528-0020