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

Paula Cramer, Graeme Fraser, Rodrigo Santucci-Silva, Sebastian Grosicki, Marie Sarah Dilhuydy, Ann Janssens, Javier Loscertales, Simon Rule, Andre Goy, Shana Traina, Eric K.H. Chan, Joris Diels, Nishan Sengupta, Michelle Mahler, Mariya Salman, Angela Howes, Asher A Chanan Khan

Research output: Contribution to journalArticle

1 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)1-10
Number of pages10
JournalLeukemia and Lymphoma
DOIs
StateAccepted/In press - Jan 4 2018

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Keywords

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

ASJC Scopus subject areas

  • Hematology
  • Oncology
  • Cancer Research

Cite this

Cramer, P., Fraser, G., Santucci-Silva, R., Grosicki, S., Dilhuydy, M. S., Janssens, A., Loscertales, J., Rule, S., Goy, A., Traina, S., Chan, E. K. H., Diels, J., Sengupta, N., Mahler, M., Salman, M., Howes, A., & Chanan Khan, A. A. (Accepted/In press). 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, 1-10. https://doi.org/10.1080/10428194.2017.1416364