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 M. Paietta, Martha Wadleigh, Richard A. Larson, Peter Emanuel, Martin Tallman, Jeff Lipton, A. Robert Turner, Michael Deininger, Brian J. Druker

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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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Leukemia, Myeloid, Chronic Phase
Cytogenetics
Survival
Toxicity
Recurrence
Imatinib Mesylate
Dasatinib
Thrombocytopenia
Protein-Tyrosine Kinases

ASJC Scopus subject areas

  • Hematology
  • Biochemistry
  • Cell Biology
  • Immunology

Cite this

Radich, J. P., Kopecky, K. J., Appelbaum, F. R., Kamel-Reid, S., Stock, W., Malnassy, G., ... 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

A randomized trial of dasatinib 100 mg versus imatinib 400 mg in newly diagnosed chronic-phase chronic myeloid leukemia. / Radich, Jerald P.; Kopecky, Kenneth J.; Appelbaum, Frederick R.; Kamel-Reid, Suzanne; Stock, Wendy; Malnassy, Greg; Paietta, Elisabeth M.; Wadleigh, Martha; Larson, Richard A.; Emanuel, Peter; Tallman, Martin; Lipton, Jeff; Turner, A. Robert; Deininger, Michael; Druker, Brian J.

In: Blood, Vol. 120, No. 19, 08.11.2012, p. 3898-3905.

Research output: Contribution to journalArticle

Radich, JP, Kopecky, KJ, Appelbaum, FR, Kamel-Reid, S, Stock, W, Malnassy, G, Paietta, EM, Wadleigh, M, Larson, RA, Emanuel, P, Tallman, M, Lipton, J, Turner, AR, Deininger, M & Druker, BJ 2012, 'A randomized trial of dasatinib 100 mg versus imatinib 400 mg in newly diagnosed chronic-phase chronic myeloid leukemia', Blood, vol. 120, no. 19, pp. 3898-3905. https://doi.org/10.1182/blood-2012-02-410688
Radich JP, Kopecky KJ, Appelbaum FR, Kamel-Reid S, Stock W, Malnassy G et al. A randomized trial of dasatinib 100 mg versus imatinib 400 mg in newly diagnosed chronic-phase chronic myeloid leukemia. Blood. 2012 Nov 8;120(19):3898-3905. https://doi.org/10.1182/blood-2012-02-410688
Radich, Jerald P. ; Kopecky, Kenneth J. ; Appelbaum, Frederick R. ; Kamel-Reid, Suzanne ; Stock, Wendy ; Malnassy, Greg ; Paietta, Elisabeth M. ; Wadleigh, Martha ; Larson, Richard A. ; Emanuel, Peter ; Tallman, Martin ; Lipton, Jeff ; Turner, A. Robert ; Deininger, Michael ; Druker, Brian J. / A randomized trial of dasatinib 100 mg versus imatinib 400 mg in newly diagnosed chronic-phase chronic myeloid leukemia. In: Blood. 2012 ; Vol. 120, No. 19. pp. 3898-3905.
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