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 Chanan-Khan

Research output: Contribution to journalArticlepeer-review

5 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)2075-2084
Number of pages10
JournalLeukemia and Lymphoma
Volume59
Issue number9
DOIs
StatePublished - Sep 2 2018

Keywords

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

ASJC Scopus subject areas

  • Hematology
  • Oncology
  • Cancer Research

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