PMID- 37646670
OWN - NLM
STAT- MEDLINE
DCOM- 20240304
LR  - 20240304
IS  - 1592-8721 (Electronic)
IS  - 0390-6078 (Print)
IS  - 0390-6078 (Linking)
VI  - 109
IP  - 3
DP  - 2024 Mar 1
TI  - Lisocabtagene maraleucel for second-line relapsed or refractory large B-cell 
      lymphoma: patient-reported outcomes from the PILOT study.
PG  - 857-866
LID - 10.3324/haematol.2023.283162 [doi]
AB  - In the single-arm, open-label, multicenter, phase II PILOT study, second-line 
      treatment with the chimeric antigen receptor (CAR) T-cell therapy lisocabtagene 
      maraleucel (liso-cel) in patients with relapsed or refractory (R/R) large B-cell 
      lymphoma (LBCL) for whom hematopoietic stem cell transplantation (HSCT) was not 
      intended resulted in high response rates, durable responses, and a safety profile 
      consistent with previous reports. Here, we analyzed changes in health-related 
      quality of life (HRQOL) in patients who received liso-cel in PILOT. Patients 
      received liso-cel, an autologous, CD19-directed, 4-1BB CAR T-cell product 
      administered at equal target doses of CD8+ and CD4+ CAR+ T cells, for a total 
      target dose of 100x10(6) CAR+ T cells. HRQOL, a secondary endpoint of PILOT, was 
      assessed as prespecified using three patient-reported outcome instruments (EORTC 
      QLQ-C30; FACT-LymS; EQ-5D-5L). Evaluable datasets for the EORTC QLQ-C30, 
      FACT-LymS, and EQ-5D-5L health utility index, and visual analog scale (EQ-VAS) 
      included 56 (92%), 49 (80%), 55 (90%), and 54 (89%) patients, respectively. 
      Clinically meaningful improvement was achieved across most post-treatment visits 
      for EORTC QLQ-C30 fatigue and FACT-LymS. Overall mean changes from baseline 
      through day 545 showed significant improvements in EORTC QLQ-C30 fatigue, pain, 
      and appetite loss, FACT-LymS, and EQ VAS. In within-patient analyses, clinically 
      meaningful improvements or maintenance in scores were observed in most patients 
      at days 90, 180, 270, and 365. HRQOL was maintained or improved in patients who 
      received liso-cel as second-line therapy in PILOT. These findings support 
      liso-cel as a preferred second-line treatment in patients with R/R LBCL not 
      intended for HSCT (clinicaltrials gov. Identifier: NCT03483103).
FAU - Gordon, Leo I
AU  - Gordon LI
AD  - Northwestern University, Feinberg School of Medicine, Robert H. Lurie 
      Comprehensive Cancer Center, Chicago, IL. l-gordon@northwestern.edu.
FAU - Liu, Fei Fei
AU  - Liu FF
AD  - Bristol Myers Squibb, Princeton, NJ.
FAU - Braverman, Julia
AU  - Braverman J
AD  - Bristol Myers Squibb, Princeton, NJ.
FAU - Hoda, Daanish
AU  - Hoda D
AD  - Intermountain Healthcare, Loveland Clinic for Blood Cancer Therapy, Salt Lake 
      City, UT.
FAU - Ghosh, Nilanjan
AU  - Ghosh N
AD  - Levine Cancer Institute, Atrium Health, Charlotte, NC.
FAU - Hamadani, Mehdi
AU  - Hamadani M
AD  - BMT and Cellular Therapy Program, Medical College of Wisconsin, Milwaukee, WI.
FAU - Hildebrandt, Gerhard C
AU  - Hildebrandt GC
AD  - Markey Cancer Center, University of Kentucky, Lexington, KY.
FAU - Peng, Lily
AU  - Peng L
AD  - Bristol Myers Squibb, Seattle, WA.
FAU - Guo, Shien
AU  - Guo S
AD  - Evidera, Bethesda, MD.
FAU - Shi, Ling
AU  - Shi L
AD  - Evidera, Bethesda, MD.
FAU - Sehgal, Alison
AU  - Sehgal A
AD  - University of Pittsburgh Medical Center, Hillman Cancer Center, Pittsburgh, PA.
LA  - eng
SI  - ClinicalTrials.gov/NCT03483103
PT  - Journal Article
PT  - Multicenter Study
DEP - 20240301
PL  - Italy
TA  - Haematologica
JT  - Haematologica
JID - 0417435
SB  - IM
MH  - Humans
MH  - Pilot Projects
MH  - *Quality of Life
MH  - *Lymphoma, Large B-Cell, Diffuse/therapy
MH  - Fatigue
MH  - Patient Reported Outcome Measures
PMC - PMC10905070
EDAT- 2023/08/30 12:42
MHDA- 2024/03/04 06:49
PMCR- 2023/08/31
CRDT- 2023/08/30 10:29
PHST- 2023/03/23 00:00 [received]
PHST- 2024/03/04 06:49 [medline]
PHST- 2023/08/30 12:42 [pubmed]
PHST- 2023/08/30 10:29 [entrez]
PHST- 2023/08/31 00:00 [pmc-release]
AID - 10.3324/haematol.2023.283162 [doi]
PST - epublish
SO  - Haematologica. 2024 Mar 1;109(3):857-866. doi: 10.3324/haematol.2023.283162.