Early response with dasatinib or imatinib in chronic myeloid leukemia: 3-year follow-up from a randomized phase 3 trial (DASISION)
Mené sur 519 patients atteints d'une leucémie myéloïde chronique en phase chronique, cet essai de phase III (DASISION) compare, du point de vue des réponses moléculaires et cytogénétiques précoces, l'efficacité du dasatinib et de l'imatinib (durée de suivi : 3 ans)
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 DASISION 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 versus 6 months with dasatinib versus 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 (PFS) and overall survival (OS) 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 PFS and OS, supporting new milestones for optimal response in patients with early CML-CP treated with tyrosine kinase inhibitors. This study was registered at ClinicalTrials.gov: NCT00481247.