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Dasatinib dose optimisation based on therapeutic drug monitoring reduces pleural effusion rates in chronic myeloid leukaemia patients

dc.rights.licenseopenen_US
dc.contributor.authorROUSSELOT, Philippe
dc.contributor.authorMOLLICA, Luigina
dc.contributor.authorGUILHOT, Joelle
dc.contributor.authorGUERCI, Agnes
dc.contributor.authorNICOLINI, Franck E.
dc.contributor.authorETIENNE, Gabriel
dc.contributor.authorLEGROS, Laurence
dc.contributor.authorCHARBONNIER, Aude
dc.contributor.authorCOITEUX, Valerie
dc.contributor.authorDARTIGEAS, Caroline
dc.contributor.authorESCOFFRE-BARBE, Martine
dc.contributor.authorROY, Lydia
dc.contributor.authorCONY-MAKHOUL, Pascale
dc.contributor.authorDUBRUILLE, Viviane
dc.contributor.authorGARDEMBAS, Martine
dc.contributor.authorHUGUET, Francoise
dc.contributor.authorREA, Delphine
dc.contributor.authorCAYSSIALS, Emilie
dc.contributor.authorGUILHOT, Francois
dc.contributor.authorBERGERON, Anne
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorMOLIMARD, Mathieu
dc.contributor.authorMAHON, Francois-Xavier
dc.contributor.authorCAYUELA, Jean-Michel
dc.contributor.authorBUSQUE, Lambert
dc.contributor.authorBOUCHET, Stephane
dc.date.accessioned2021-08-24T08:29:53Z
dc.date.available2021-08-24T08:29:53Z
dc.date.issued2021-06-30
dc.identifier.issn0007-1048en_US
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/110197
dc.description.abstractEnDasatinib 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).
dc.language.isoENen_US
dc.subject.enPharmacology
dc.subject.enChronic leukaemia
dc.subject.enTyrosine kinases
dc.title.enDasatinib dose optimisation based on therapeutic drug monitoring reduces pleural effusion rates in chronic myeloid leukaemia patients
dc.typeArticle de revueen_US
dc.identifier.doi10.1111/bjh.17654en_US
dc.subject.halSciences du Vivant [q-bio]/Santé publique et épidémiologieen_US
dc.identifier.pubmed34195988en_US
bordeaux.journalBritish Journal of Haematologyen_US
bordeaux.page393-402en_US
bordeaux.volume194en_US
bordeaux.hal.laboratoriesBordeaux Population Health Research Center (BPH) - UMR 1219en_US
bordeaux.issue2en_US
bordeaux.institutionUniversité de Bordeauxen_US
bordeaux.institutionINSERMen_US
bordeaux.teamPharmacoEpi-Drugsen_US
bordeaux.peerReviewedouien_US
bordeaux.inpressnonen_US
bordeaux.identifier.funderIDBristol-Myers Squibben_US
hal.identifierhal-03324903
hal.version1
hal.date.transferred2021-08-24T08:29:57Z
hal.exporttrue
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