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

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.

Keywords:

• Chronic lymphocytic leukemia
• ibrutinib
• patient-reported outcomes
• fatigue
• health-related quality of life
• physical functioning

Acknowledgements

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.

Potential conflict of interest

Disclosure forms provided by the authors are available with the full text of this article online at https://doi.org/10.1080/10428194.2017.1416364

Additional information

Funding

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.