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dc.contributor.authorCochrane, Tara
dc.contributor.authorEnrico, Alicia
dc.contributor.authorGomez-Almaguer, David
dc.contributor.authorHadjiev, Evgueniy
dc.contributor.authorLech-Maranda, Ewa
dc.contributor.authorMasszi, Tamas
dc.contributor.authorNikitin, Eugene
dc.contributor.authorRobak, Tadeusz
dc.contributor.authorWeinkove, Robert
dc.contributor.authorWu, Shang-Ju
dc.contributor.authorSail, Kavita R
dc.contributor.authorPesko, John
dc.contributor.authorPai, Madhavi
dc.contributor.authorKomlosi, Viktor
dc.contributor.authorAnderson, Mary Ann
dc.date.accessioned2021-10-22T04:01:49Z
dc.date.available2021-10-22T04:01:49Z
dc.date.issued2021
dc.identifier.issn1042-8194en_US
dc.identifier.doi10.1080/10428194.2021.1986217en_US
dc.identifier.urihttp://hdl.handle.net/10072/409401
dc.description.abstractVenetoclax, a potent B-cell lymphoma-2 (BCL-2) inhibitor, has demonstrated clinical efficacy in chronic lymphocytic leukemia (CLL). VENICE II is an open-label, single-arm, phase 3b study (NCT02980731) evaluating the impact of venetoclax monotherapy (400 mg once daily) for ≤2 years on health-related quality of life (HRQoL) of patients with relapsed/refractory CLL. The primary endpoint was mean change in the global health status (GHS)/quality of life (QoL) subscale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) from baseline to Week 48. Overall, 210 patients received ≥1 dose of venetoclax; median treatment duration was 67.4 weeks. The primary endpoint was met with mean improvement of +9.3 points (n = 156, 95% confidence interval 6.1-12.5; p=.004) in GHS/QoL. At Week 48, clinically meaningful improvements were observed for role functioning, fatigue, and insomnia domains of EORTC QLQ-C30, suggesting venetoclax monotherapy has a positive impact on HRQoL. No new safety signals were reported.en_US
dc.description.peerreviewedYesen_US
dc.languageengen_US
dc.publisherInforma UK Limiteden_US
dc.relation.ispartofjournalLeuk Lymphomaen_US
dc.subject.fieldofresearchClinical sciencesen_US
dc.subject.fieldofresearchcode3202en_US
dc.subject.keywordsCLLen_US
dc.subject.keywordshealth-related quality of lifeen_US
dc.subject.keywordsrelapsed/refractoryen_US
dc.subject.keywordsvenetoclaxen_US
dc.titleImpact of venetoclax monotherapy on the quality of life of patients with relapsed or refractory chronic lymphocytic leukemia: results from the phase 3b VENICE II trialen_US
dc.typeJournal articleen_US
dc.type.descriptionC1 - Articlesen_US
dcterms.bibliographicCitationCochrane, T; Enrico, A; Gomez-Almaguer, D; Hadjiev, E; Lech-Maranda, E; Masszi, T; Nikitin, E; Robak, T; Weinkove, R; Wu, S-J; Sail, KR; Pesko, J; Pai, M; Komlosi, V; Anderson, MA, Impact of venetoclax monotherapy on the quality of life of patients with relapsed or refractory chronic lymphocytic leukemia: results from the phase 3b VENICE II trial, Leuk Lymphoma, 2021en_US
dcterms.licensehttps://creativecommons.org/licenses/by-nc-nd/4.0/en_US
dc.date.updated2021-10-21T01:24:09Z
dc.description.versionVersion of Record (VoR)en_US
gro.description.notepublicThis publication has been entered in Griffith Research Online as an advanced online version.en_US
gro.rights.copyright© 2021 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group. This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License (http://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited, and is not altered, transformed, or built upon in any way.en_US
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gro.griffith.authorCochrane, Tara


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