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.
DOI
10.1080/10428194.2017.1416364
Publication Date
2018-01-03
Publication Title
Leukemia and Lymphoma
Volume
59
Issue
9
Publisher
Taylor & Francis
ISSN
1029-2403
Embargo Period
2024-11-19
Additional Links
https://www.ncbi.nlm.nih.gov/pubmed/29295653
Keywords
Chronic lymphocytic leukemia, fatigue, health-related quality of life, ibrutinib, patient-reported outcomes, physical functioning
First Page
2075
Last Page
2084
Recommended Citation
Cramer, P., Fraser, G., Santucci-Silva, R., Grosicki, S., & et al. (2018) '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.', Leukemia and Lymphoma, 59(9), pp. 2075-2084. Taylor & Francis: Available at: https://doi.org/10.1080/10428194.2017.1416364
