Dasatinib dose optimisation based on therapeutic drug monitoring reduces pleural effusion rates in chronic myeloid leukaemia patients.
Adolescent
Adult
Aged
Aged, 80 and over
Antineoplastic Agents
/ administration & dosage
Dasatinib
/ administration & dosage
Dose-Response Relationship, Drug
Drug Monitoring
Female
Humans
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
/ drug therapy
Male
Middle Aged
Pleural Effusion
/ chemically induced
Prospective Studies
Protein Kinase Inhibitors
/ administration & dosage
Treatment Outcome
Young Adult
chronic leukaemia
pharmacology
tyrosine kinases
Journal
British journal of haematology
ISSN: 1365-2141
Titre abrégé: Br J Haematol
Pays: England
ID NLM: 0372544
Informations de publication
Date de publication:
07 2021
07 2021
Historique:
received:
14
02
2021
accepted:
11
05
2021
pubmed:
2
7
2021
medline:
21
12
2021
entrez:
1
7
2021
Statut:
ppublish
Résumé
Dasatinib is a second-generation BCR-ABL1 tyrosine kinase inhibitor approved for patients with chronic myeloid leukaemia (CML). Dasatinib 100 mg per day is associated with an increased risk of pleural effusion (PlEff). We randomly evaluated whether therapeutic drug monitoring (TDM) may reduce dasatinib-associated significant adverse events (AEs) by 12 months (primary endpoint). Eligible patients started dasatinib at 100 mg per day followed by dasatinib (C)min assessment. Patients considered overdosed [(C)min ≥ 3 nmol/l) were randomised between a dose-reduction strategy (TDM arm) and standard of care (control arm). Out of 287 evaluable patients, 80 patients were randomised. The primary endpoint was not met due to early haematological AEs occurring before effective dose reduction. However, a major reduction in the cumulative incidence of PlEff was observed in the TDM arm compared to the control arm (4% vs. 15%; 11% vs. 35% and 12% vs. 39% at one, two and three years, respectively (P = 0·0094)). Molecular responses were superimposable in all arms. Dasatinib TDM during treatment initiation was feasible and resulted in a significant reduction of the incidence of PlEff in the long run, without impairing molecular responses. (NCT01916785; https://clinicaltrials.gov).
Substances chimiques
Antineoplastic Agents
0
Protein Kinase Inhibitors
0
Dasatinib
RBZ1571X5H
Banques de données
ClinicalTrials.gov
['NCT01916785']
Types de publication
Clinical Trial, Phase II
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
393-402Commentaires et corrections
Type : CommentIn
Informations de copyright
© 2021 British Society for Haematology and John Wiley & Sons Ltd.
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