PMID- 36999993
OWN - NLM
STAT- MEDLINE
DCOM- 20230516
LR  - 20230721
IS  - 1557-3265 (Electronic)
IS  - 1078-0432 (Print)
IS  - 1078-0432 (Linking)
VI  - 29
IP  - 10
DP  - 2023 May 15
TI  - Safety and Efficacy of Axicabtagene Ciloleucel versus Standard of Care in 
      Patients 65 Years of Age or Older with Relapsed/Refractory Large B-Cell Lymphoma.
PG  - 1894-1905
LID - 10.1158/1078-0432.CCR-22-3136 [doi]
AB  - PURPOSE: Older patients with relapsed/refractory (R/R) large B-cell lymphoma 
      (LBCL) may be considered ineligible for curative-intent therapy including 
      high-dose chemotherapy with autologous stem-cell transplantation (HDT-ASCT). 
      Here, we report outcomes of a preplanned subgroup analysis of patients >/=65 years 
      in ZUMA-7. PATIENTS AND METHODS: Patients with LBCL refractory to or relapsed </=12 
      months after first-line chemoimmunotherapy were randomized 1:1 to axicabtagene 
      ciloleucel [axi-cel; autologous anti-CD19 chimeric antigen receptor (CAR) T-cell 
      therapy] or standard of care (SOC; 2-3 cycles of chemoimmunotherapy followed by 
      HDT-ASCT). The primary endpoint was event-free survival (EFS). Secondary 
      endpoints included safety and patient-reported outcomes (PROs). RESULTS: 
      Fifty-one and 58 patients aged >/=65 years were randomized to axi-cel and SOC, 
      respectively. Median EFS was greater with axi-cel versus SOC (21.5 vs. 2.5 
      months; median follow-up: 24.3 months; HR, 0.276; descriptive P < 0.0001). 
      Objective response rate was higher with axi-cel versus SOC (88% vs. 52%; OR, 
      8.81; descriptive P < 0.0001; complete response rate: 75% vs. 33%). Grade >/=3 
      adverse events occurred in 94% of axi-cel and 82% of SOC patients. No grade 5 
      cytokine release syndrome or neurologic events occurred. In the quality-of-life 
      analysis, the mean change in PRO scores from baseline at days 100 and 150 favored 
      axi-cel for EORTC QLQ-C30 Global Health, Physical Functioning, and EQ-5D-5L 
      visual analog scale (descriptive P < 0.05). CAR T-cell expansion and baseline 
      serum inflammatory profile were comparable in patients >/=65 and <65 years. 
      CONCLUSIONS: Axi-cel is an effective second-line curative-intent therapy with a 
      manageable safety profile and improved PROs for patients >/=65 years with R/R LBCL.
CI  - (c)2023 The Authors; Published by the American Association for Cancer Research.
FAU - Westin, Jason R
AU  - Westin JR
AUID- ORCID: 0000-0002-1824-2337
AD  - The University of Texas MD Anderson Cancer Center, Houston, Texas.
FAU - Locke, Frederick L
AU  - Locke FL
AUID- ORCID: 0000-0001-9063-6691
AD  - Moffitt Cancer Center, Tampa, Florida.
FAU - Dickinson, Michael
AU  - Dickinson M
AUID- ORCID: 0000-0002-1492-5966
AD  - Peter MacCallum Cancer Centre, Royal Melbourne Hospital and the University of 
      Melbourne, Melbourne, Victoria, Australia.
FAU - Ghobadi, Armin
AU  - Ghobadi A
AUID- ORCID: 0000-0001-8848-8474
AD  - Washington University School of Medicine, St. Louis, Missouri.
FAU - Elsawy, Mahmoud
AU  - Elsawy M
AUID- ORCID: 0000-0001-9872-2471
AD  - Division of Hematology, Department of Medicine, Dalhousie University, Halifax, 
      Nova Scotia, Canada.
FAU - van Meerten, Tom
AU  - van Meerten T
AUID- ORCID: 0000-0002-5581-6950
AD  - University Medical Center Groningen, Groningen, The Netherlands, on behalf of 
      HOVON/LLPC.
FAU - Miklos, David B
AU  - Miklos DB
AUID- ORCID: 0000-0003-0717-4305
AD  - Stanford University School of Medicine, Stanford, California.
FAU - Ulrickson, Matthew L
AU  - Ulrickson ML
AUID- ORCID: 0000-0002-1458-7813
AD  - Banner MD Anderson Cancer Center, Gilbert, Arizona.
FAU - Perales, Miguel-Angel
AU  - Perales MA
AUID- ORCID: 0000-0002-5910-4571
AD  - Memorial Sloan-Kettering Cancer Center, New York, New York.
FAU - Farooq, Umar
AU  - Farooq U
AUID- ORCID: 0000-0001-7891-9891
AD  - University of Iowa, Iowa City, Iowa.
FAU - Wannesson, Luciano
AU  - Wannesson L
AUID- ORCID: 0000-0002-5902-0757
AD  - Istituto Oncologico della Svizzera Italiana, Bellinzona, Switzerland.
FAU - Leslie, Lori
AU  - Leslie L
AUID- ORCID: 0000-0002-7265-4076
AD  - John Theurer Cancer Center, Hackensack, New Jersey.
FAU - Kersten, Marie Jose
AU  - Kersten MJ
AUID- ORCID: 0000-0002-8904-3802
AD  - Amsterdam UMC, University of Amsterdam, Cancer Center Amsterdam, Amsterdam, The 
      Netherlands, on behalf of HOVON/LLPC.
FAU - Jacobson, Caron A
AU  - Jacobson CA
AUID- ORCID: 0000-0002-0180-0654
AD  - Dana-Farber Cancer Institute, Boston, Massachusetts.
FAU - Pagel, John M
AU  - Pagel JM
AUID- ORCID: 0000-0001-5745-8125
AD  - Swedish Cancer Institute, Seattle, Washington.
FAU - Wulf, Gerald
AU  - Wulf G
AUID- ORCID: 0000-0002-7669-3785
AD  - University Medicine Gottingen, Gottingen, Germany.
FAU - Johnston, Patrick
AU  - Johnston P
AUID- ORCID: 0000-0002-3212-3510
AD  - Mayo Clinic, Rochester, Minnesota.
FAU - Rapoport, Aaron P
AU  - Rapoport AP
AUID- ORCID: 0000-0003-0043-3562
AD  - University of Maryland School of Medicine and Marlene and Stewart Greenebaum 
      Comprehensive Cancer Center, Baltimore, Maryland.
FAU - Du, Linqiu
AU  - Du L
AUID- ORCID: 0000-0002-1265-7363
AD  - Kite, a Gilead Company, Santa Monica, California.
FAU - Vardhanabhuti, Saran
AU  - Vardhanabhuti S
AUID- ORCID: 0000-0003-1558-2755
AD  - Kite, a Gilead Company, Santa Monica, California.
FAU - Filosto, Simone
AU  - Filosto S
AUID- ORCID: 0000-0002-7854-998X
AD  - Kite, a Gilead Company, Santa Monica, California.
FAU - Shah, Jina
AU  - Shah J
AUID- ORCID: 0000-0002-1053-2508
AD  - Kite, a Gilead Company, Santa Monica, California.
FAU - Snider, Julia T
AU  - Snider JT
AUID- ORCID: 0000-0003-0017-4863
AD  - Kite, a Gilead Company, Santa Monica, California.
FAU - Cheng, Paul
AU  - Cheng P
AUID- ORCID: 0000-0002-9436-7764
AD  - Kite, a Gilead Company, Santa Monica, California.
FAU - To, Christina
AU  - To C
AUID- ORCID: 0000-0001-7164-8072
AD  - Kite, a Gilead Company, Santa Monica, California.
FAU - Oluwole, Olalekan O
AU  - Oluwole OO
AUID- ORCID: 0000-0001-8525-9641
AD  - Vanderbilt University Cancer Center, Nashville, Tennessee.
FAU - Sureda, Anna
AU  - Sureda A
AUID- ORCID: 0000-0002-1238-6970
AD  - Hematology Department, Institut Catala d'Oncologia-Hospitalet, IDIBELL, 
      Universitat de Barcelona, Spain.
LA  - eng
GR  - P30 CA008748/CA/NCI NIH HHS/United States
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Clin Cancer Res
JT  - Clinical cancer research : an official journal of the American Association for 
      Cancer Research
JID - 9502500
RN  - U2I8T43Y7R (axicabtagene ciloleucel)
RN  - 0 (Biological Products)
RN  - 0 (Antigens, CD19)
SB  - IM
CIN - 1078-0432. doi: 10.1158/1078-0432.CCR-29-10-HI
MH  - Humans
MH  - Aged
MH  - Standard of Care
MH  - Immunotherapy, Adoptive/adverse effects
MH  - *Lymphoma, Large B-Cell, Diffuse/pathology
MH  - *Biological Products/adverse effects
MH  - Antigens, CD19
PMC - PMC10183830
EDAT- 2023/04/01 06:00
MHDA- 2023/05/16 06:42
PMCR- 2023/05/15
CRDT- 2023/03/31 09:54
PHST- 2022/11/01 00:00 [received]
PHST- 2023/01/18 00:00 [revised]
PHST- 2023/02/28 00:00 [accepted]
PHST- 2023/05/16 06:42 [medline]
PHST- 2023/04/01 06:00 [pubmed]
PHST- 2023/03/31 09:54 [entrez]
PHST- 2023/05/15 00:00 [pmc-release]
AID - 724973 [pii]
AID - CCR-22-3136 [pii]
AID - 10.1158/1078-0432.CCR-22-3136 [doi]
PST - ppublish
SO  - Clin Cancer Res. 2023 May 15;29(10):1894-1905. doi: 
      10.1158/1078-0432.CCR-22-3136.