1. Treatment‐free remission after dasatinib in patients with chronic myeloid leukaemia in chronic phase with deep molecular response: Final 5‐year analysis of DASFREE
- Author
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Shah, Neil P, García‐Gutiérrez, Valentín, Jiménez‐Velasco, Antonio, Larson, Sarah M, Saussele, Susanne, Rea, Delphine, Mahon, François‐Xavier, Levy, Moshe Yair, Gómez‐Casares, María Teresa, Mauro, Michael J, Sy, Oumar, Martin‐Regueira, Patricia, and Lipton, Jeffrey H
- Subjects
Biomedical and Clinical Sciences ,Cardiovascular Medicine and Haematology ,Clinical Research ,Rare Diseases ,6.1 Pharmaceuticals ,Cancer ,Humans ,Dasatinib ,Protein Kinase Inhibitors ,Treatment Outcome ,Neoplasm Recurrence ,Local ,Leukemia ,Myelogenous ,Chronic ,BCR-ABL Positive ,chronic phase chronic myeloid leukaemia ,dasatinib ,deep molecular response ,major molecular response ,treatment-free remission ,Cardiorespiratory Medicine and Haematology ,Immunology ,Cardiovascular medicine and haematology - Abstract
Patients with chronic myeloid leukaemia in chronic phase (CML-CP) who have a sustained deep molecular response (DMR) are eligible to discontinue treatment and attempt treatment-free remission (TFR). In the DASFREE study (ClinicalTrials.gov; NCT01850004), the 2-year TFR rate after dasatinib discontinuation was 46%; here we present the 5-year update. Patients with a stable DMR after ≥2 years of dasatinib therapy discontinued treatment and were followed for 5 years. At a minimum follow-up of 60 months, in 84 patients discontinuing dasatinib, the 5-year TFR rate was 44% (n = 37). No relapses occurred after month 39 and all evaluable patients who relapsed and restarted dasatinib (n = 46) regained a major molecular response in a median of 1.9 months. The most common adverse event during the off-treatment period was arthralgia (18%, 15/84); a total of 15 withdrawal events were reported in nine patients (11%). At the 5-year final follow-up, almost half of the patients who discontinued dasatinib after a sustained DMR maintained TFR. All evaluable patients who experienced a relapse quickly regained a DMR after restarting dasatinib, demonstrating that dasatinib discontinuation is a viable and potentially long-term option in patients with CML-CP. The safety profile is consistent with the previous report.
- Published
- 2023