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- Title
Treatment‐free remission after dasatinib in patients with chronic myeloid leukaemia in chronic phase with deep molecular response: Final 5‐year analysis of DASFREE.
- Authors
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; Lipton, Jeffrey H.
- Abstract
Summary: 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.
- Subjects
CHRONIC myeloid leukemia; DASATINIB
- Publication
British Journal of Haematology, 2023, Vol 202, Issue 5, p942
- ISSN
0007-1048
- Publication type
Article
- DOI
10.1111/bjh.18883