Health-related quality-of-life in treatment-naive CLL/SLL patients treated with zanubrutinib versus bendamustine plus rituximab

Paolo Ghia, Gisoo Barnes, Keri Yang, Constantine S. Tam, Tadeusz Robak, Jennifer R. Brown, Brad S. Kahl, Tian Tian, Andy Szeto, Jason C. Paik, Mazyar Shadman

Research output: Contribution to journalArticlepeer-review

Abstract

Objective: Zanubrutinib is a highly selective, next-generation Bruton’s tyrosine kinase inhibitor. In the phase 3 SEQUOIA trial (NCT03336333), treatment with zanubrutinib resulted in significantly improved progression-free survival compared to bendamustine plus rituximab (BR) in adult patients with treatment-naïve chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) without del(17p). The current analysis compared the effects of zanubrutinib versus BR on patients’ health-related quality-of-life (HRQoL). Methods: In the SEQUOIA trial, patient-reported outcomes (PROs) were assessed at baseline and every 12 weeks (3 cycles) using the EORTC QLQ-C30 and EQ-5D-5L. Descriptive analyses were performed on all the questionnaires’ scales and a mixed model for repeated measures was performed using the key QLQ-C30 endpoints of global health status/QoL (GHS/QoL), physical and role functioning, and symptoms of fatigue, pain, diarrhea, and nausea/vomiting at weeks 12 and 24. Results: Compared with BR-treated patients, those in the zanubrutinib arm experienced greater improvements in HRQoL outcomes at both weeks 12 and 24. By week 24, mean change differences (95% confidence interval) between the arms were significant for GHS/QoL (4.9 [0.9, 9.0]), physical functioning (3.8 [0.8, 6.7]), diarrhea (−6.2 [−10.0, −2.5]), fatigue (−4.5 [−8.9, −0.1]), and nausea/vomiting (−4.5 [−8.9, −0.1]); role functioning (4.8 [−0.2, 9.7]) was marginally better in the zanubrutinib arm and there were no differences in pain symptoms (−0.4 [−4.3, 5.1]) between the arms. Conclusions: During the first 24 weeks of treatment, zanubrutinib was associated with better HRQoL outcomes in patients with treatment-naive CLL/SLL without del(17p) compared to BR. Trial registration: The SEQUOIA trial is registered on clinicaltrials.gov as SEQUOIA trial (NCT03336333).

Original languageEnglish
Pages (from-to)1505-1511
Number of pages7
JournalCurrent Medical Research and Opinion
Volume39
Issue number11
DOIs
StatePublished - 2023

Keywords

  • SEQUOIA
  • Zanubrutinib
  • bendamustine
  • chronic lymphocytic leukemia
  • health-related quality-of-life
  • patient-reported outcomes
  • rituximab
  • small cell lymphocytic lymphoma

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