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Randomized Controlled Trial Multicenter Study
Early response with dasatinib or imatinib in chronic myeloid leukemia: 3-year follow-up from a randomized phase 3 trial (DASISION).
- Elias Jabbour, Hagop M Kantarjian, Giuseppe Saglio, Juan Luis Steegmann, Neil P Shah, Concepción Boqué, Charles Chuah, Carolina Pavlovsky, Jirí Mayer, Jorge Cortes, Michele Baccarani, Dong-Wook Kim, M Brigid Bradley-Garelik, Hesham Mohamed, Mark Wildgust, and Andreas Hochhaus.
- The University of Texas MD Anderson Cancer Center, Houston, TX;
- Blood. 2014 Jan 23; 123 (4): 494-500.
AbstractThis analysis explores the impact of early cytogenetic and molecular responses on the outcomes of patients with chronic myeloid leukemia in chronic phase (CML-CP) in the phase 3 DASatinib versus Imatinib Study In treatment-Naive CML patients trial with a minimum follow-up of 3 years. Patients with newly diagnosed CML-CP were randomized to receive 100 mg dasatinib (n = 259) or 400 mg imatinib (n = 260) once daily. The retrospective landmark analysis included patients evaluable at the relevant time point (3, 6, or 12 months). Median time to complete cytogenetic response was 3 vs 6 months with dasatinib vs imatinib. At 3 and 6 months, the proportion of patients with BCR-ABL transcript levels ≤10% was higher in the dasatinib arm. Deeper responses at 3, 6, and 12 months were observed in a higher proportion of patients on dasatinib therapy and were associated with better 3-year progression-free survival and overall survival in both arms. First-line dasatinib resulted in faster and deeper responses compared with imatinib. The achievement of an early molecular response was predictive of improved progression-free survival and overall survival, supporting new milestones for optimal response in patients with early CML-CP treated with tyrosine kinase inhibitors. This study was registered at www.clinicaltrials.gov as NCT00481247.
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