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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

Hess, Georg ; Rule, Simon ; Jurczak, Wojciech ; Jerkeman, Mats LU ; Santucci Silva, Rodrigo ; Rusconi, Chiara ; Caballero, Dolores ; Joao, Cristina ; Witzens-Harig, Mathias and Bence-Bruckler, Isabelle , et al. (2017) In Leukemia and Lymphoma 58(12). p.2824-2832
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... (More)

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.

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publishing date
type
Contribution to journal
publication status
published
subject
keywords
Bruton’s tyrosine kinase inhibitor, EQ-5D-5L, FACT-Lym, ibrutinib, mantle cell lymphoma, patient-reported outcomes
in
Leukemia and Lymphoma
volume
58
issue
12
pages
2824 - 2832
publisher
Taylor & Francis
external identifiers
  • pmid:28556689
  • wos:000406290000007
  • scopus:85019717990
ISSN
1042-8194
DOI
10.1080/10428194.2017.1326034
language
English
LU publication?
yes
id
7f6a61bd-c916-431b-a8d8-114b693712c1
date added to LUP
2017-06-21 14:52:46
date last changed
2024-07-07 20:11:41
@article{7f6a61bd-c916-431b-a8d8-114b693712c1,
  abstract     = {{<p>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.</p>}},
  author       = {{Hess, Georg and Rule, Simon and Jurczak, Wojciech and Jerkeman, Mats and Santucci Silva, Rodrigo and Rusconi, Chiara and Caballero, Dolores and Joao, Cristina and Witzens-Harig, Mathias and Bence-Bruckler, Isabelle and Cho, Seok-Goo and Zhou, Wenjiong and Goldberg, Jenna D and Trambitas, Cristina and Enny, Christopher and Vermeulen, Jessica and Traina, Shana and Chiou, Chiun Fang and Diels, Joris and Dreyling, Martin}},
  issn         = {{1042-8194}},
  keywords     = {{Bruton’s tyrosine kinase inhibitor; EQ-5D-5L; FACT-Lym; ibrutinib; mantle cell lymphoma; patient-reported outcomes}},
  language     = {{eng}},
  month        = {{05}},
  number       = {{12}},
  pages        = {{2824--2832}},
  publisher    = {{Taylor & Francis}},
  series       = {{Leukemia and Lymphoma}},
  title        = {{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}},
  url          = {{http://dx.doi.org/10.1080/10428194.2017.1326034}},
  doi          = {{10.1080/10428194.2017.1326034}},
  volume       = {{58}},
  year         = {{2017}},
}