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A randomized trial of dasatinib 100 mg vs imatinib 400 mg in newly diagnosed chronic phase chromic 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, Brian J. Druker

Abstract

Tyrosine kinase inhibitor (TKI) therapy with imatinib (IM), dasatinib (DAS), or nilotinib is very effective in chronic phase chronic myeloid leukemia (CML). 253 patients with newly diagnosed chronic phase CML were randomized to IM 400 mg/qd or DAS 100 mg/qd. The proportion of patients achieving 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 progression-free survival was similar in the two arms. Among patients who achieved hematologic CR, 3 year relapse-free survival was 91% with DAS and 88% with IM 400mg. Grade 3 and 4 toxicities were most commonly hematologic, including thrombocytopenia in 18% and 8% of DAS and IM patients, respectively. DAS induced more CCyR and deeper molecular responses after 12 months, compared to IM 400mg, and with a median follow up of 3.0 years there have been very few deaths, relapses or progressions in the two arms. In summary, DAS compared to IM appeared to have more short-term cytogenetic and molecular response, more hematological toxicity, and similar overall survival. This trial is registered at www.clinicaltrials.gov as NCT00070499.

  • Submitted February 14, 2012.
  • Accepted July 18, 2012.