PMID- 34478487
OWN - NLM
STAT- MEDLINE
DCOM- 20211101
LR  - 20220330
IS  - 2473-9537 (Electronic)
IS  - 2473-9529 (Print)
IS  - 2473-9529 (Linking)
VI  - 5
IP  - 20
DP  - 2021 Oct 26
TI  - Comparison of 2-year outcomes with CAR T cells (ZUMA-1) vs salvage chemotherapy 
      in refractory large B-cell lymphoma.
PG  - 4149-4155
LID - 10.1182/bloodadvances.2020003848 [doi]
AB  - The SCHOLAR-1 international retrospective study highlighted poor clinical 
      outcomes and survival among patients with refractory large B-cell lymphoma (LBCL) 
      treated with conventional chemotherapy. Axicabtagene ciloleucel (axi-cel), an 
      autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy, demonstrated 
      durable responses in patients with refractory LBCL in the pivotal phase 1/2 
      ZUMA-1 study (NCT02348216). Here, we compared SCHOLAR-1 with the 2-year outcomes 
      of ZUMA-1. Prior to comparison of clinical outcomes, propensity scoring (based on 
      a broad set of prognostic covariates) was used to create balance between ZUMA-1 
      and SCHOLAR-1 patients. In the pivotal phase 2 portion of ZUMA-1, 101 patients 
      received axi-cel and were evaluable for response and survival. In SCHOLAR-1, 434 
      and 424 patients were evaluable for response and survival, respectively. ZUMA-1 
      patients were more heavily pretreated than were SCHOLAR-1 patients. The median 
      follow-up was 27.1 months in ZUMA-1. The objective response rate (ORR) and 
      complete response rate were 83% and 54% in ZUMA-1 vs 34% and 12% in SCHOLAR-1, 
      respectively. The 2-year survival rate was 54% in ZUMA-1 and 20% in SCHOLAR-1, 
      and a 73% reduction in the risk of death was observed in ZUMA-1 vs SCHOLAR-1. 
      These results were consistent with those of an additional standardization 
      analysis in which strata were limited to 2 prognostic factors (refractory 
      categorization and presence/absence of stem cell transplant after refractoriness 
      to chemotherapy) to conserve sample size. Despite the limitations of a 
      nonrandomized analysis, these results indicate that axi-cel produces durable 
      responses and a substantial survival benefit vs non-CAR T-cell salvage regimens 
      for patients with refractory LBCL.
CI  - (c) 2021 by The American Society of Hematology. Licensed under Creative Commons 
      Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0), 
      permitting only noncommercial, nonderivative use with attribution. All other 
      rights reserved.
FAU - Neelapu, Sattva S
AU  - Neelapu SS
AUID- ORCID: 0000-0003-1045-4914
AD  - Department of Lymphoma and Myeloma, The University of Texas MD Anderson Cancer 
      Center, Houston, TX.
FAU - Locke, Frederick L
AU  - Locke FL
AD  - Department of Blood and Marrow Transplant and Cellular Immunotherapy, Moffitt 
      Cancer Center, Tampa, FL.
FAU - Bartlett, Nancy L
AU  - Bartlett NL
AUID- ORCID: 0000-0001-8470-394X
AD  - Siteman Cancer Center, Washington University Medical School, St Louis, MO.
FAU - Lekakis, Lazaros J
AU  - Lekakis LJ
AD  - Sylvester Comprehensive Care Center, University of Miami Health System, Miami, 
      FL.
FAU - Reagan, Patrick M
AU  - Reagan PM
AD  - James P. Wilmot Cancer Institute, University of Rochester School of Medicine, 
      Rochester, NY.
FAU - Miklos, David B
AU  - Miklos DB
AUID- ORCID: 0000-0003-0717-4305
AD  - Department of Medicine - Blood and Marrow Transplantation, Stanford University 
      School of Medicine, Stanford, CA.
FAU - Jacobson, Caron A
AU  - Jacobson CA
AD  - Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA.
FAU - Braunschweig, Ira
AU  - Braunschweig I
AD  - Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY.
FAU - Oluwole, Olalekan O
AU  - Oluwole OO
AUID- ORCID: 0000-0001-8525-9641
AD  - Division of Hematology/Oncology, Vanderbilt-Ingram Cancer Center, Vanderbilt 
      University Medical Center, Nashville, TN.
FAU - Siddiqi, Tanya
AU  - Siddiqi T
AUID- ORCID: 0000-0001-5292-8298
AD  - Department of Hematology and Hematopoietic Cell Transplantation, City of Hope 
      National Medical Center, Duarte, CA.
FAU - Lin, Yi
AU  - Lin Y
AD  - Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN.
FAU - Crump, Michael
AU  - Crump M
AD  - Canadian Cancer Trials Group, Queen's University, Kingston, ON, Canada.
FAU - Kuruvilla, John
AU  - Kuruvilla J
AD  - Princess Margaret Cancer Center, Toronto, ON, Canada.
FAU - Van Den Neste, Eric
AU  - Van Den Neste E
AD  - Department of Hematology, Cliniques Universitaires UCL Saint-Luc, Brussels, 
      Belgium.
FAU - Farooq, Umar
AU  - Farooq U
AD  - Division of Hematology, Oncology, and Blood and Marrow Transplantation, 
      Department of Internal Medicine, University of Iowa, Iowa City, IA.
FAU - Navale, Lynn
AU  - Navale L
AD  - Kite, a Gilead Company, Santa Monica, CA.
FAU - DePuy, Venita
AU  - DePuy V
AD  - Bowden Analytics, Raleigh, NC; and.
FAU - Kim, Jenny J
AU  - Kim JJ
AD  - Kite, a Gilead Company, Santa Monica, CA.
FAU - Gisselbrecht, Christian
AU  - Gisselbrecht C
AD  - Hopital Saint Louis, Paris, France.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Blood Adv
JT  - Blood advances
JID - 101698425
SB  - IM
MH  - Humans
MH  - *Lymphoma, Large B-Cell, Diffuse/drug therapy
MH  - Retrospective Studies
MH  - Salvage Therapy
MH  - Survival Rate
MH  - T-Lymphocytes
PMC - PMC8945634
EDAT- 2021/09/04 06:00
MHDA- 2021/11/03 06:00
PMCR- 2021/10/22
CRDT- 2021/09/03 17:19
PHST- 2020/11/18 00:00 [received]
PHST- 2021/05/20 00:00 [accepted]
PHST- 2021/09/04 06:00 [pubmed]
PHST- 2021/11/03 06:00 [medline]
PHST- 2021/09/03 17:19 [entrez]
PHST- 2021/10/22 00:00 [pmc-release]
AID - S2473-9529(21)00502-4 [pii]
AID - 2021/ADV2020003848 [pii]
AID - 10.1182/bloodadvances.2020003848 [doi]
PST - ppublish
SO  - Blood Adv. 2021 Oct 26;5(20):4149-4155. doi: 10.1182/bloodadvances.2020003848.