PMID- 33904895
OWN - NLM
STAT- MEDLINE
DCOM- 20210531
LR  - 20220531
IS  - 2473-9537 (Electronic)
IS  - 2473-9529 (Print)
IS  - 2473-9529 (Linking)
VI  - 5
IP  - 8
DP  - 2021 Apr 27
TI  - Effect of lisocabtagene maraleucel on HRQoL and symptom severity in 
      relapsed/refractory large B-cell lymphoma.
PG  - 2245-2255
LID - 10.1182/bloodadvances.2020003503 [doi]
AB  - CD19-directed chimeric antigen receptor (CAR) T-cell therapy has shown efficacy 
      as a third-line or later treatment in patients with relapsed/refractory large 
      B-cell lymphoma (LBCL). Using the European Organization for Research and 
      Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and the EuroQol 
      5-Dimension 5-Level (EQ-5D-5L) questionnaire, we evaluated the impact of CAR 
      T-cell treatment with lisocabtagene maraleucel (liso-cel) on health-related 
      quality of life (HRQoL) and symptoms in patients with relapsed/refractory LBCL in 
      the ongoing, open-label, nonrandomized TRANSCEND NHL 001 trial. Clinically 
      meaningful improvement was observed in EORTC QLQ-C30 scores for global health 
      status/QoL, based on a minimally important difference of 10 points at 2 to 18 
      months after liso-cel infusion. There were no clinically meaningful changes in 
      physical functioning and pain, whereas clinically meaningful improvements were 
      observed in fatigue at 2, 12, and 18 months. The proportion of patients with 
      clinically meaningful improvement in global health status/QoL was generally 
      higher for treatment responders than for nonresponders. A trend toward decreased 
      mean EQ-5D-5L index scores was observed at 1 month after liso-cel infusion, 
      followed by subsequent increases through 18 months. Mean EQ-5D-5L visual analog 
      scale scores increased from 2 through 18 months. In summary, patients with 
      relapsed/refractory LBCL treated with liso-cel had early, sustained, and 
      clinically meaningful improvements in HRQoL and symptoms that correlated with 
      antitumor activity. This study was registered at www.clinicaltrials.gov as 
      #NCT02631044.
CI  - (c) 2021 by The American Society of Hematology.
FAU - Patrick, Donald L
AU  - Patrick DL
AD  - Department of Health Services, University of Washington, Seattle, WA.
AD  - Fred Hutchinson Cancer Research Center, Seattle, WA.
FAU - Powers, Annette
AU  - Powers A
AD  - Bristol Myers Squibb, Princeton, NJ; and.
FAU - Jun, Monika Parisi
AU  - Jun MP
AD  - Bristol Myers Squibb, Princeton, NJ; and.
FAU - Kim, Yeonhee
AU  - Kim Y
AD  - Bristol Myers Squibb, Seattle, WA.
FAU - Garcia, Jacob
AU  - Garcia J
AD  - Bristol Myers Squibb, Seattle, WA.
FAU - Dehner, Christine
AU  - Dehner C
AD  - Bristol Myers Squibb, Seattle, WA.
FAU - Maloney, David G
AU  - Maloney DG
AD  - Fred Hutchinson Cancer Research Center, Seattle, WA.
LA  - eng
SI  - ClinicalTrials.gov/NCT02631044
PT  - Clinical Trial
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Blood Adv
JT  - Blood advances
JID - 101698425
RN  - 0 (Antigens, CD19)
SB  - IM
MH  - Antigens, CD19
MH  - Humans
MH  - Immunotherapy, Adoptive
MH  - *Lymphoma, Large B-Cell, Diffuse/drug therapy
MH  - *Quality of Life
MH  - Surveys and Questionnaires
PMC - PMC8095132
COIS- Conflict-of-interest disclosure: D.L.P. has received honoraria from Juno 
      Therapeutics, Celgene, Allakos, and Bristol Myers Squibb, and research funding 
      through the University of Washington and Fred Hutchinson Cancer Center. C.D., 
      Y.K., M.P.J., and A.P. are employees of Bristol Myers Squibb and hold stock in 
      the company. J.G. was an employee of Bristol Myers Squibb when the work reported 
      in this article was done and holds stock in the company; his current affiliation 
      is Umoja Biopharma, Seattle, WA. D.G.M. has received honoraria for consulting 
      from A2 Biotherapeutics, Amgen, BioLineRx, Bristol Myers Squibb, Celgene, 
      Genentech, Gilead, Juno Therapeutics, Kite Pharma, MorphoSys, Novartis, and 
      Pharmacyclics and research funding (paid to his institution, Fred Hutchinson 
      Cancer Research Center) from Bristol Myers Squibb, Celgene, Juno Therapeutics, 
      and Kite Pharma; holds stock options in A2 Biotherapeutics and has patents 
      pending (not issued or licenses, no royalties or licenses) from Juno 
      Therapeutics.
EDAT- 2021/04/28 06:00
MHDA- 2021/06/01 06:00
PMCR- 2021/04/27
CRDT- 2021/04/27 12:16
PHST- 2020/09/28 00:00 [received]
PHST- 2021/03/02 00:00 [accepted]
PHST- 2021/04/27 12:16 [entrez]
PHST- 2021/04/28 06:00 [pubmed]
PHST- 2021/06/01 06:00 [medline]
PHST- 2021/04/27 00:00 [pmc-release]
AID - S2473-9529(21)00285-8 [pii]
AID - 2020/ADV2020003503 [pii]
AID - 10.1182/bloodadvances.2020003503 [doi]
PST - ppublish
SO  - Blood Adv. 2021 Apr 27;5(8):2245-2255. doi: 10.1182/bloodadvances.2020003503.