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 Kantarjian, Jorge Cortes, Dong Wook Kim, Pedro Dorlhiac-Llacer, Ricardo Pasquini, John DiPersio, Martin C. Müller, Jerald P. Radich, H. Jean Khoury, Nina Khoroshko, M. Brigid Bradley-Garelik, Chao Zhu, Martin S. Tallman

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137 Scopus citations

Abstract

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.

Original languageEnglish
Pages (from-to)6322-6329
Number of pages8
JournalBlood
Volume113
Issue number25
DOIs
StatePublished - Nov 19 2009

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    Kantarjian, H., Cortes, J., Kim, D. W., Dorlhiac-Llacer, P., Pasquini, R., DiPersio, J., Müller, M. C., Radich, J. P., Khoury, H. J., Khoroshko, N., Bradley-Garelik, M. B., Zhu, C., & Tallman, M. S. (2009). 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. Blood, 113(25), 6322-6329. https://doi.org/10.1182/blood-2008-11-186817