TY - JOUR
T1 - Early response with dasatinib or imatinib in chronic myeloid leukemia
T2 - 3-year follow-up from a randomized phase 3 trial (DASISION)
AU - Jabbour, Elias
AU - Kantarjian, Hagop M.
AU - Saglio, Giuseppe
AU - Steegmann, Juan Luis
AU - Shah, Neil P.
AU - Boqué, Concepción
AU - Chuah, Charles
AU - Pavlovsky, Carolina
AU - Mayer, Jiří
AU - Cortes, Jorge
AU - Baccarani, Michele
AU - Kim, Dong Wook
AU - Bradley-Garelik, M. Brigid
AU - Mohamed, Hesham
AU - Wildgust, Mark
AU - Hochhaus, Andreas
PY - 2014/1/23
Y1 - 2014/1/23
N2 - 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.
AB - 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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U2 - 10.1182/blood-2013-06-511592
DO - 10.1182/blood-2013-06-511592
M3 - Article
C2 - 24311723
AN - SCOPUS:84893136765
SN - 0006-4971
VL - 123
SP - 494
EP - 500
JO - Blood
JF - Blood
IS - 4
ER -