Improvement 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.
dc.contributor.author | Cramer, P | |
dc.contributor.author | Fraser, G | |
dc.contributor.author | Santucci-Silva, R | |
dc.contributor.author | Grosicki, S | |
dc.contributor.author | Dilhuydy, M-S | |
dc.contributor.author | Janssens, A | |
dc.contributor.author | Loscertales, J | |
dc.contributor.author | Rule, Simon | |
dc.contributor.author | Goy, A | |
dc.contributor.author | Traina, S | |
dc.contributor.author | Chan, EKH | |
dc.contributor.author | Diels, J | |
dc.contributor.author | Sengupta, N | |
dc.contributor.author | Mahler, M | |
dc.contributor.author | Salman, M | |
dc.contributor.author | Howes, A | |
dc.contributor.author | Chanan-Khan, A | |
dc.date.accessioned | 2021-09-21T12:27:42Z | |
dc.date.available | 2021-09-21T12:27:42Z | |
dc.date.issued | 2018-01-03 | |
dc.identifier.issn | 1026-8022 | |
dc.identifier.issn | 1029-2403 | |
dc.identifier.uri | http://hdl.handle.net/10026.1/17909 | |
dc.description.abstract |
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.extent | 2075-2084 | |
dc.format.medium | Print-Electronic | |
dc.language | en | |
dc.language.iso | en | |
dc.publisher | Taylor & Francis | |
dc.subject | Chronic lymphocytic leukemia | |
dc.subject | fatigue | |
dc.subject | health-related quality of life | |
dc.subject | ibrutinib | |
dc.subject | patient-reported outcomes | |
dc.subject | physical functioning | |
dc.title | Improvement 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. | |
dc.type | journal-article | |
dc.type | Journal Article | |
dc.type | Randomized Controlled Trial | |
dc.type | Research Support, Non-U.S. Gov't | |
plymouth.author-url | https://www.ncbi.nlm.nih.gov/pubmed/29295653 | |
plymouth.issue | 9 | |
plymouth.volume | 59 | |
plymouth.publication-status | Published | |
plymouth.journal | Leukemia and Lymphoma | |
dc.identifier.doi | 10.1080/10428194.2017.1416364 | |
plymouth.organisational-group | /Plymouth | |
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.publisher.place | United States | |
dcterms.dateAccepted | 2017-12-02 | |
dc.rights.embargodate | 2021-9-22 | |
dc.identifier.eissn | 1029-2403 | |
dc.rights.embargoperiod | Not known | |
rioxxterms.versionofrecord | 10.1080/10428194.2017.1416364 | |
rioxxterms.licenseref.uri | http://www.rioxx.net/licenses/all-rights-reserved | |
rioxxterms.licenseref.startdate | 2018-01-03 | |
rioxxterms.type | Journal Article/Review |