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 - Funding Information:
This study was funded by Janssen Research & Development. We thank the patients who participated in this trial and their families, and the global study investigators and study staff at each of the clinical sites. The authors would like to thank RJ Wirth and Jim McGinley from Vector Psychometric Group for conducting the linear regression analysis, Charles Phelps and Pushpike Thilakarathne of Janssen for providing statistical support, and Chiun-Fang Chiou and Jay Trudeau of Janssen for their critical review of the manuscript.
Funding Information:
Writing assistance was provided by Jean Turner and Safeer Mughal of PAREXEL, and was funded by Janssen Global Services.
Funding Information:
Writing assistance was provided by Jean Turner and Safeer Mughal of PAREXEL, and was funded by Janssen Global Services. PC has received research grants from Gilead, GlaxoSmithKline, F. Hoffmann-La Roche, Janssen-Cilag, and Novartis; honoraria for scientific talks from F. Hoffmann-La Roche and Janssen-Cilag; honoraria for advisory boards from AbbVie, AstraZeneca, Janssen-Cilag and Novartis; and travel grant support from Astellas, Gilead, F. Hoffmann-La Roche, Janssen-Cilag, and Mundipharma. GF has received grants and personal fees from Celgene and Janssen; and personal fees from Abbvie and Lundbeck. M-SD has received personal fees and non-financial support from Abbvie, Gilead, and Janssen. JL has received fees for speaker bureaus and advisory boards from Abbvie, Gilead, Janssen, and Roche. SR has received grants and personal fees from Janssen and Pharmacyclics. AG has received fees for speaker bureaus and advisory boards from Johnson & Johnson/Pharmacyclics and Takeda; consultancy and advisory board fees from Celgene; research support and consultancy fees from Genentech; and honoraria from Acerta. ST, EKHC, NS, MM, MS, and AH are employees of Janssen. JD is an employee and equity owner of Janssen. RS-S, SG, AJ, and AC-K declare no conflicts of interest. This study was funded by Janssen Research & Development. We thank the patients who participated in this trial and their families, and the global study investigators and study staff at each of the clinical sites. The authors would like to thank RJ Wirth and Jim McGinley from Vector Psychometric Group for conducting the linear regression analysis, Charles Phelps and Pushpike Thilakarathne of Janssen for providing statistical support, and Chiun-Fang Chiou and Jay Trudeau of Janssen for their critical review of the manuscript.
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 -