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, Andreas Hochhaus, 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, Andreas Hochhaus
Abstract
This 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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Source: PubMed