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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 p.1-9
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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keywords
Bruton’s tyrosine kinase inhibitor, EQ-5D-5L, FACT-Lym, ibrutinib, mantle cell lymphoma, patient-reported outcomes
in
Leukemia and Lymphoma
pages
1 - 9
publisher
Taylor & Francis
external identifiers
  • scopus:85019717990
  • wos:000406290000007
ISSN
1042-8194
DOI
10.1080/10428194.2017.1326034
language
English
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yes
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7f6a61bd-c916-431b-a8d8-114b693712c1
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2017-06-21 14:52:46
date last changed
2017-09-18 11:42:12
@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},
  keyword      = {Bruton’s tyrosine kinase inhibitor,EQ-5D-5L,FACT-Lym,ibrutinib,mantle cell lymphoma,patient-reported outcomes},
  language     = {eng},
  month        = {05},
  pages        = {1--9},
  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},
  year         = {2017},
}