TY - JOUR
T1 - 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
AU - Hess, Georg
AU - Rule, Simon
AU - Jurczak, Wojciech
AU - Jerkeman, Mats
AU - Santucci Silva, Rodrigo
AU - Rusconi, Chiara
AU - Caballero, Dolores
AU - Joao, Cristina
AU - Witzens-Harig, Mathias
AU - Bence-Bruckler, Isabelle
AU - Cho, Seok Goo
AU - Zhou, Wenjiong
AU - Goldberg, Jenna D.
AU - Trambitas, Cristina
AU - Enny, Christopher
AU - Vermeulen, Jessica
AU - Traina, Shana
AU - Chiou, Chiun Fang
AU - Diels, Joris
AU - Dreyling, Martin
N1 - Funding Information:
This study was funded by Janssen Research and Development. Writing assistance was provided by Michelle Olsher, PhD (PAREXEL, Hackensack, NJ) and was funded by Janssen Global Services, LLC.
Publisher Copyright:
© 2017 Informa UK Limited, trading as Taylor & Francis Group.
PY - 2017/12/2
Y1 - 2017/12/2
N2 - 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.
AB - 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.
KW - Bruton’s tyrosine kinase inhibitor
KW - EQ-5D-5L
KW - FACT-Lym
KW - ibrutinib
KW - mantle cell lymphoma
KW - patient-reported outcomes
UR - http://www.scopus.com/inward/record.url?scp=85019717990&partnerID=8YFLogxK
U2 - 10.1080/10428194.2017.1326034
DO - 10.1080/10428194.2017.1326034
M3 - Article
C2 - 28556689
AN - SCOPUS:85019717990
SN - 1042-8194
VL - 58
SP - 2824
EP - 2832
JO - Leukemia and Lymphoma
JF - Leukemia and Lymphoma
IS - 12
ER -
