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dc.contributor.authorCramer, Pen
dc.contributor.authorFraser, Gen
dc.contributor.authorSantucci-Silva, Ren
dc.contributor.authorGrosicki, Sen
dc.contributor.authorDilhuydy, M-Sen
dc.contributor.authorJanssens, Aen
dc.contributor.authorLoscertales, Jen
dc.contributor.authorRule, Sen
dc.contributor.authorGoy, Aen
dc.contributor.authorTraina, Sen
dc.contributor.authorChan, EKHen
dc.contributor.authorDiels, Jen
dc.contributor.authorSengupta, Nen
dc.contributor.authorMahler, Men
dc.contributor.authorSalman, Men
dc.contributor.authorHowes, Aen
dc.contributor.authorChanan-Khan, Aen

Health-related quality of life (HRQoL) is an important endpoint, especially in clinical trials for malignancies with a long course of disease, such as chronic lymphocytic leukemia (CLL). Patient-reported outcomes were examined in the randomized, double-blind, placebo-controlled HELIOS study to assess the impact of treatment with the Bruton's tyrosine kinase inhibitor ibrutinib, added to bendamustine plus rituximab (BR) background therapy. Measures included FACIT-Fatigue, EORTC QLQ-C30, QLQ-CLL16, and EQ-5D-5L. Of 578 patients enrolled, 540 (93%) provided FACIT-Fatigue responses at baseline. Most had only a moderate degree of impairment at baseline; mean values did not appear to change over time in either treatment arm, suggesting that adding ibrutinib to BR did not impact health-related quality of life. However, post-hoc analyses showed that subgroups of patients with the worst fatigue, physical functional status, and well-being at baseline had greater improvements in these outcomes with ibrutinib plus BR treatment versus placebo.

dc.format.extent2075 - 2084en
dc.publisherTaylor & Francisen
dc.subjectChronic lymphocytic leukemiaen
dc.subjecthealth-related quality of lifeen
dc.subjectpatient-reported outcomesen
dc.subjectphysical functioningen
dc.titleImprovement of fatigue, physical functioning, and well-being among patients with severe impairment at baseline receiving ibrutinib in combination with bendamustine and rituximab for relapsed chronic lymphocytic leukemia/small lymphocytic lymphoma in the HELIOS study.en
dc.typeJournal Article
plymouth.journalLeukemia and Lymphomaen
plymouth.organisational-group/Plymouth/Faculty of Health
plymouth.organisational-group/Plymouth/Faculty of Health/Peninsula Medical School
plymouth.organisational-group/Plymouth/REF 2021 Researchers by UoA
plymouth.organisational-group/Plymouth/REF 2021 Researchers by UoA/UoA01 Clinical Medicine
plymouth.organisational-group/Plymouth/REF 2021 Researchers by UoA/UoA01 Clinical Medicine/UoA01 Clinical Medicine
plymouth.organisational-group/Plymouth/Research Groups
plymouth.organisational-group/Plymouth/Research Groups/Institute of Translational and Stratified Medicine (ITSMED)
plymouth.organisational-group/Plymouth/Research Groups/Institute of Translational and Stratified Medicine (ITSMED)/CBR
plymouth.organisational-group/Plymouth/Research Groups/Institute of Translational and Stratified Medicine (ITSMED)/CCT&PS
plymouth.organisational-group/Plymouth/Users by role
plymouth.organisational-group/Plymouth/Users by role/Academics
dc.rights.embargoperiodNot knownen
rioxxterms.typeJournal Article/Reviewen

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