Blood Journal
Leading the way in experimental and clinical research in hematology

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

  1. Jerald P. Radich1,*,
  2. Kenneth J. Kopecky2,
  3. Frederick R. Appelbaum1,
  4. Suzanne Kamel-Reid3,
  5. Wendy Stock4,
  6. Greg Malnassy4,
  7. Elisabeth Paietta5,
  8. Martha Wadleigh6,
  9. Richard A. Larson4,
  10. Peter Emanuel7,
  11. Martin Tallman8,
  12. Jeff Lipton9,
  13. A. Robert Turner10, and
  14. Brian J. Druker11
  1. 1 Fred Hutchinson Cancer Research Center, Seattle, WA, United States;
  2. 2 SWOG Statistical Center, Seattle, WA, United States;
  3. 3 Princess Margaret Hospital, Toronto, ON, Canada;
  4. 4 University of Chicago, Chicago, IL, United States;
  5. 5 Montefiore Medical Center North Division, Bronx, NY, United States;
  6. 6 Dana-Farber Cancer Insitute, Boston, MA, United States;
  7. 7 University of Arkansas for Medical Sciences, Little Rock, AR, United States;
  8. 8 Memorial Sloan Kettering Center, New York, NY, United States;
  9. 9 University of Toronto, Toronto, ON, Canada;
  10. 10 Cross Cancer Institute, Edmonton, AB, Canada;
  11. 11 Oregon Health Sciences Center, Portland, OR, United States
  1. * Corresponding author; email: jradich{at}


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 as NCT00070499.

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