Please use this identifier to cite or link to this item: https://hdl.handle.net/20.500.12530/39910
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dc.contributor.authorHochhaus, A
dc.contributor.authorMasszi, T
dc.contributor.authorGiles, F J
dc.contributor.authorRadich, J P
dc.contributor.authorRoss, D M
dc.contributor.authorGómez Casares, M T
dc.contributor.authorHellmann, A
dc.contributor.authorStentoft, J
dc.contributor.authorConneally, E
dc.contributor.authorGarcía-Gutiérrez, V
dc.contributor.authorGattermann, N
dc.contributor.authorWiktor-Jedrzejczak, W
dc.contributor.authorle Coutre, P D
dc.contributor.authorMartino, B
dc.contributor.authorSaussele, S
dc.contributor.authorMenssen, H D
dc.contributor.authorDeng, W
dc.contributor.authorKrunic, N
dc.contributor.authorBedoucha, V
dc.contributor.authorSaglio, G
dc.date.accessioned2019-07-01T06:28:04Z-
dc.date.available2019-07-01T06:28:04Z-
dc.date.issued2017
dc.identifier.citationLeukemia.2017 07;(31)7:1525-1531
dc.identifier.urihttps://hdl.handle.net/20.500.12530/39910-
dc.description.abstractThe single-arm, phase 2 ENESTfreedom trial assessed the potential for treatment-free remission (TFR; i.e., the ability to maintain a molecular response after stopping therapy) following frontline nilotinib treatment. Patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase with MR4.5 (BCR-ABL1⩽0.0032% on the International Scale (BCR-ABL1IS)) and ⩾2 years of frontline nilotinib therapy were enrolled. Patients with sustained deep molecular response during the 1-year nilotinib consolidation phase were eligible to stop treatment and enter the TFR phase. Patients with loss of major molecular response (MMR; BCR-ABL1IS⩽0.1%) during the TFR phase reinitiated nilotinib. In total, 215 patients entered the consolidation phase, of whom 190 entered the TFR phase. The median duration of nilotinib before stopping treatment was 43.5 months. At 48 weeks after stopping nilotinib, 98 patients (51.6%; 95% confidence interval, 44.2-58.9%) remained in MMR or better (primary end point). Of the 86 patients who restarted nilotinib in the treatment reinitiation phase after loss of MMR, 98.8% and 88.4%, respectively, regained MMR and MR4.5 by the data cutoff date. Consistent with prior reports of imatinib-treated patients, musculoskeletal pain-related events were reported in 24.7% of patients in the TFR phase (consolidation phase, 16.3%).
dc.language.isoeng
dc.rightsopenAccess-
dc.subject.meshAdult
dc.subject.meshAged
dc.subject.meshAged, 80 and over
dc.subject.meshFemale
dc.subject.meshHumans
dc.subject.meshLeukemia, Myelogenous, Chronic, BCR-ABL Positive
dc.subject.meshMale
dc.subject.meshMiddle Aged
dc.subject.meshProtein Kinase Inhibitors
dc.subject.meshPyrimidines
dc.subject.meshQuality of Life
dc.titleTreatment-free remission following frontline nilotinib in patients with chronic myeloid leukemia in chronic phase: results from the ENESTfreedom study.
dc.typeArtículo
dc.identifier.pubmedID28218239
dc.format.volume31
dc.format.page1525-1531
dc.identifier.e-issn1476-5551
dc.identifier.journalLeukemia
dc.identifier.doi10.1038/leu.2017.63
dc.format.number7
dc.identifier.pmcPMC5508077
dc.pubmedtypeClinical Trial, Phase II
dc.pubmedtypeJournal Article
dc.pubmedtypeResearch Support, Non-U.S. Gov't
Appears in Collections:Fundaciones e Institutos de Investigación > IIS H. U. Ramón y Cajal > Artículos

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