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Treatment-free remission after dasatinib in patients with chronic myeloid leukaemia in chronic phase with deep molecular response: final 5-year analysis of DASFREE: original paper

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 discontin...

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Main Authors: Shah, Neil P. (Author) , García-Gutiérrez, Valentín (Author) , Jiménez-Velasco, Antonio (Author) , Larson, Sarah M. (Author) , Saußele, Susanne (Author) , Rea, Delphine (Author) , Mahon, François-Xavier (Author) , Levy, Moshe Yair (Author) , Gómez-Casares, María Teresa (Author) , Mauro, Michael J. (Author) , Sy, Oumar (Author) , Martin-Regueira, Patricia (Author) , Lipton, Jeffrey H. (Author)
Format: Article (Journal)
Language:English
Published: September 2023
In: British journal of haematology
Year: 2023, Volume: 202, Issue: 5, Pages: 942-952
ISSN:1365-2141
DOI:10.1111/bjh.18883
Online Access:Verlag, kostenfrei, Volltext: https://doi.org/10.1111/bjh.18883
Verlag, kostenfrei, Volltext: https://onlinelibrary.wiley.com/doi/abs/10.1111/bjh.18883
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Author Notes:Neil P. Shah, Valentín García-Gutiérrez, Antonio Jiménez-Velasco, Sarah M. Larson, Susanne Saussele, Delphine Rea, François-Xavier Mahon, Moshe Yair Levy, María Teresa Gómez-Casares, Michael J. Mauro, Oumar Sy, Patricia Martin-Regueira, Jeffrey H. Lipton
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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.
Item Description:Online veröffentlicht: 29. Mai 2023
Gesehen am 29.02.2024
Physical Description:Online Resource
ISSN:1365-2141
DOI:10.1111/bjh.18883

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