TY - JOUR
T1 - 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
AU - Cramer, Paula
AU - Fraser, Graeme
AU - Santucci-Silva, Rodrigo
AU - Grosicki, Sebastian
AU - Dilhuydy, Marie Sarah
AU - Janssens, Ann
AU - Loscertales, Javier
AU - Rule, Simon
AU - Goy, Andre
AU - Traina, Shana
AU - Chan, Eric K.H.
AU - Diels, Joris
AU - Sengupta, Nishan
AU - Mahler, Michelle
AU - Salman, Mariya
AU - Howes, Angela
AU - Chanan-Khan, Asher
N1 - Publisher Copyright:
© 2018, © 2018 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.
PY - 2018/9/2
Y1 - 2018/9/2
N2 - 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.
AB - 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.
KW - Chronic lymphocytic leukemia
KW - fatigue
KW - health-related quality of life
KW - ibrutinib
KW - patient-reported outcomes
KW - physical functioning
UR - http://www.scopus.com/inward/record.url?scp=85040980708&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85040980708&partnerID=8YFLogxK
U2 - 10.1080/10428194.2017.1416364
DO - 10.1080/10428194.2017.1416364
M3 - Article
C2 - 29295653
AN - SCOPUS:85040980708
SN - 1042-8194
VL - 59
SP - 2075
EP - 2084
JO - Leukemia and Lymphoma
JF - Leukemia and Lymphoma
IS - 9
ER -