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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 (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 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 Citing Articles via Google Scholar Google Scholar Articles by Kantarjian, H. Articles by Tallman, M. S Search for Related Content PubMed PubMed Citation Articles by Kantarjian, H. Articles by Tallman, M. S Social Bookmarking                   What's this?  Previous Article  |  Next Article  Submitted November 12, 2008 Accepted March 13, 2009 Phase III 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 Kantarjian*, Jorge Cortes, Dong-Wook Kim, Pedro Dorlhiac-Llacer, Ricardo Pasquini, John DiPersio, Martin C Muller, Jerald P Radich, H Jean Khoury, Nina Khoroshko, M Brigid Bradley-Garelik, Chao Zhu, and Martin S Tallman MD Anderson Cancer Center, Houston, TX, United States St Mary's Hospital, Seoul, Korea, Republic of Hospital das Clinicas, Sao Paolo, Brazil Hospital De Clinicas De Curitiba, Curitiba, Brazil Washington University School of Medicine, St. Louis, MO, United States Medizinische Fakultaet Mannheim, University of Heidelberg, Mannheim, Germany Fred Hutchinson Cancer Research Center, Seattle, WA, United States Emory University School of Medicine, Atlanta, GA, United States National Research Hematology Center, Moscow, Russian Federation Bristol-Myers Squibb, Wallingford, CT, United States Northwestern University Feinberg School of Medicine, Chicago, IL, United States * Corresponding author; email: hkantarj{at}mdanderson.org. 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 (CML-AP) intolerant or resistant to imatinib. A phase III study compared the efficacy and safety of dasatinib 140 mg once-daily with the current twice-daily regimen. Here, results from the subgroup with CML-AP (n = 317) with a median follow-up of 15 months (treatment duration 0.03-31.15 months) are reported. Among patients randomized to once- (n = 158) or twice-daily (n = 159) treatment, rates of major hematologic (HR) and cytogenetic (MCyR) responses were comparable (major HR: 66% vs 68%; MCyR: 39% vs 43%, respectively). Estimated progression-free survival rates at 24 months were 51% and 55%, while overall survival rates were 63% vs 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. Trial number: CA180-035 (This trial is registered at www.clinicaltrials.gov) CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this?

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