A randomized trial of dasatinib 100 mg versus imatinib 400 mg in newly diagnosed chronic-phase chronic myeloid leukemia

Jerald P. Radich, Kenneth J. Kopecky, Frederick R. Appelbaum, Suzanne Kamel-Reid, Wendy Stock, Greg Malnassy, Elisabeth Paietta, Martha Wadleigh, Richard A. Larson, Peter Emanuel, Martin Tallman, Jeff Lipton, A. Robert Turner, Michael Deininger, Brian J. Druker

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122 Scopus citations

Abstract

Tyrosine kinase inhibitor therapy with imatinib (IM), dasatinib (DAS), or nilotinib is very effective in chronic-phase chronic myeloid leukemia. Two hundred fiftythree patients with newly diagnosed chronic-phase chronic myeloid leukemia were randomized to IM 400 mg/day or DAS 100 mg/day. The proportion of patients achieving a complete cytogenetic remission rate was superior with DAS (84% vs 69%), as was the 12-month molecular response by the proportions of patients achieving > 3-log, > 4-log, and > 4.5-log reduction in BCR-ABL transcript levels. Overall and progressionfree survival was similar in the 2 arms. Among patients who achieved hematologic CR, 3-year relapse-free survival was 91% with DAS and 88% with IM 400 mg. Grade 3 and 4 toxicities were most commonly hematologic, including thrombocytopenia in 18% and 8% of DAS and IM patients, respectively. DAS induced more complete cytogenetic response and deeper molecular responses after 12 months, compared with IM 400 mg, and with a median follow-up of 3.0 years there have been very few deaths, relapses, or progressions in the 2 arms. In summary, DAS compared with IM appeared to have more short-term cytogenetic and molecular response, more hematologic toxicity, and similar overall survival. This trial is registered at www. clinicaltrials.gov as NCT00070499.

Original languageEnglish (US)
Pages (from-to)3898-3905
Number of pages8
JournalBlood
Volume120
Issue number19
DOIs
StatePublished - Nov 8 2012

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ASJC Scopus subject areas

  • Biochemistry
  • Immunology
  • Hematology
  • Cell Biology

Cite this

Radich, J. P., Kopecky, K. J., Appelbaum, F. R., Kamel-Reid, S., Stock, W., Malnassy, G., Paietta, E., Wadleigh, M., Larson, R. A., Emanuel, P., Tallman, M., Lipton, J., Turner, A. R., Deininger, M., & Druker, B. J. (2012). A randomized trial of dasatinib 100 mg versus imatinib 400 mg in newly diagnosed chronic-phase chronic myeloid leukemia. Blood, 120(19), 3898-3905. https://doi.org/10.1182/blood-2012-02-410688