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  • 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

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    Cochrane517365-Published.pdf (2.442Mb)
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    Version of Record (VoR)
    Author(s)
    Cochrane, Tara
    Enrico, Alicia
    Gomez-Almaguer, David
    Hadjiev, Evgueniy
    Lech-Maranda, Ewa
    Masszi, Tamas
    Nikitin, Eugene
    Robak, Tadeusz
    Weinkove, Robert
    Wu, Shang-Ju
    Sail, Kavita R
    Pesko, John
    Pai, Madhavi
    Komlosi, Viktor
    Anderson, Mary Ann
    Griffith University Author(s)
    Cochrane, Tara
    Year published
    2021
    Metadata
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    Abstract
    Venetoclax, 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 ...
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    Venetoclax, 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.
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    Journal Title
    Leuk Lymphoma
    DOI
    https://doi.org/10.1080/10428194.2021.1986217
    Copyright Statement
    © 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.
    Note
    This publication has been entered in Griffith Research Online as an advanced online version.
    Subject
    Clinical sciences
    CLL
    health-related quality of life
    relapsed/refractory
    venetoclax
    Publication URI
    http://hdl.handle.net/10072/409401
    Collection
    • Journal articles

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