Health-related quality of life data from a phase 3, international, randomized, open-label, multicenter study in patients with previously treated mantle cell lymphoma treated with ibrutinib versus temsirolimus

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Abstract

Mantle cell lymphoma (MCL) is a rare, aggressive, incurable B-cell malignancy. Ibrutinib has been shown to be highly active for patients with relapsed/refractory (R/R) MCL. The RAY trial (MCL3001) was a phase 3, randomized, open-label, multicenter study that compared ibrutinib with temsirolimus in patients with R/R MCL. Active disease is frequently associated with impaired functional status and reduced well-being. Therefore, the current study employed two patient-reported outcome instruments, the Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) and the EQ-5D-5L, to assess symptoms, well-being, health status, and health-related quality of life of patients on treatment within the RAY trial. We found that patients on ibrutinib had substantial improvement in FACT-Lym subscale and total scores, and had improvement in EQ-5D-5L utility and VAS scores compared with temsirolimus patients, indicating a superior well-being. These improvements in well-being correlated with clinical response, indicating that better health-related quality of life was associated with decreased disease burden.

Detaljer

Författare
  • Georg Hess
  • Simon Rule
  • Wojciech Jurczak
  • Mats Jerkeman
  • Rodrigo Santucci Silva
  • Chiara Rusconi
  • Dolores Caballero
  • Cristina Joao
  • Mathias Witzens-Harig
  • Isabelle Bence-Bruckler
  • Seok-Goo Cho
  • Wenjiong Zhou
  • Jenna D Goldberg
  • Cristina Trambitas
  • Christopher Enny
  • Jessica Vermeulen
  • Shana Traina
  • Chiun Fang Chiou
  • Joris Diels
  • Martin Dreyling
Enheter & grupper
Externa organisationer
  • University of Mainz
  • Plymouth University
  • Jagellonian University
  • Skåne University Hospital
  • Instituto de Ensino e Pesquisa São Lucas
  • Niguarda Hospital
  • University Hospital of Salamanca
  • Champalimaud Foundation
  • University Hospital Heidelberg
  • Janssen Research & Development LLC
  • Janssen Inc.
  • Janssen Pharmaceutica
  • University Hospital Munich
Forskningsområden

Ämnesklassifikation (UKÄ) – OBLIGATORISK

  • Cancer och onkologi

Nyckelord

Originalspråkengelska
Sidor (från-till)2824-2832
TidskriftLeukemia and Lymphoma
Volym58
Utgivningsnummer12
StatusPublished - 2017
PublikationskategoriForskning
Peer review utfördJa