Universität zu Köln

Cramer, Paula, Fraser, Graeme, Santucci-Silva, Rodrigo, Grosicki, Sebastian ORCID: 0000-0003-2644-1050, Dilhuydy, Marie-Sarah, Janssens, Ann, Loscertales, Javier, Rule, Simon, Goy, Andre ORCID: 0000-0001-5125-6522, Traina, Shana, Chan, Eric K. H., Diels, Joris, Sengupta, Nishan, Mahler, Michelle, Salman, Mariya, Howes, Angela and Chanan-Khan, Asher (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. Leuk. Lymphoma, 59 (9). S. 2075 - 2085. ABINGDON: TAYLOR & FRANCIS LTD. ISSN 1029-2403

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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.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Cramer, Paula UNSPECIFIED UNSPECIFIED UNSPECIFIED Fraser, Graeme UNSPECIFIED UNSPECIFIED UNSPECIFIED Santucci-Silva, Rodrigo UNSPECIFIED UNSPECIFIED UNSPECIFIED Grosicki, Sebastian UNSPECIFIED orcid.org/0000-0003-2644-1050 UNSPECIFIED Dilhuydy, Marie-Sarah UNSPECIFIED UNSPECIFIED UNSPECIFIED Janssens, Ann UNSPECIFIED UNSPECIFIED UNSPECIFIED Loscertales, Javier UNSPECIFIED UNSPECIFIED UNSPECIFIED Rule, Simon UNSPECIFIED UNSPECIFIED UNSPECIFIED Goy, Andre UNSPECIFIED orcid.org/0000-0001-5125-6522 UNSPECIFIED Traina, Shana UNSPECIFIED UNSPECIFIED UNSPECIFIED Chan, Eric K. H. UNSPECIFIED UNSPECIFIED UNSPECIFIED Diels, Joris UNSPECIFIED UNSPECIFIED UNSPECIFIED Sengupta, Nishan UNSPECIFIED UNSPECIFIED UNSPECIFIED Mahler, Michelle UNSPECIFIED UNSPECIFIED UNSPECIFIED Salman, Mariya UNSPECIFIED UNSPECIFIED UNSPECIFIED Howes, Angela UNSPECIFIED UNSPECIFIED UNSPECIFIED Chanan-Khan, Asher UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-202160
DOI:	10.1080/10428194.2017.1416364
Journal or Publication Title:	Leuk. Lymphoma
Volume:	59
Number:	9
Page Range:	S. 2075 - 2085
Date:	2018
Publisher:	TAYLOR & FRANCIS LTD
Place of Publication:	ABINGDON
ISSN:	1029-2403
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language QUALITY-OF-LIFE; CANCER-PATIENTS; DRUG DEVELOPMENT; EORTC QLQ-C30; ANEMIA; SCALE; MULTICENTER; ONCOLOGY; TRIALS; VALIDATION Multiple languages Oncology; Hematology Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/20216