PMID- 35911769
OWN - NLM
STAT- MEDLINE
DCOM- 20220802
LR  - 20220804
IS  - 1664-3224 (Electronic)
IS  - 1664-3224 (Linking)
VI  - 13
DP  - 2022
TI  - Best Treatment Option for Patients With Refractory Aggressive B-Cell Lymphoma in 
      the CAR-T Cell Era: Real-World Evidence From GELTAMO/GETH Spanish Groups.
PG  - 855730
LID - 10.3389/fimmu.2022.855730 [doi]
LID - 855730
AB  - Real-world evidence comparing the efficacy of chimeric antigen receptor (CAR) 
      T-cell therapy against that of the previous standard of care (SOC) for refractory 
      large B-cell lymphoma (LBCL) is scarce. We retrospectively collected data from 
      patients with LBCL according to SCHOLAR-1 criteria treated with commercial CAR 
      T-cell therapy in Spain (204 patients included and 192 treated, 101 with 
      axicabtagene ciloleucel [axi-cel], and 91 with tisagenlecleucel [tisa-cel]) and 
      compared the results with a historical refractory population of patients (n = 81) 
      obtained from the GELTAMO-IPI study. We observed superior efficacy for CAR-T 
      therapy (for both axi-cel and tisa-cel) over pSOC, with longer progression-free 
      survival (PFS) (median of 5.6 vs. 4-6 months, p </= 0.001) and overall survival 
      (OS) (median of 15 vs. 8 months, p < 0.001), independently of other prognostic 
      factors (HR: 0.59 (95% CI: 0.44-0.80); p < 0.001] for PFS, and 0.45 [(95% CI: 
      0.31-0.64)] for OS). Within the CAR-T cohort, axi-cel showed longer PFS (median 
      of 7.3 versus 2.8 months, respectively, p = 0.027) and OS (58% versus 42% at 12 
      months, respectively, p = 0.048) than tisa-cel. These differences were maintained 
      in the multivariable analysis. On the other hand, axi-cel was independently 
      associated with a higher risk of severe cytokine release syndrome and 
      neurotoxicity. Our results suggest that the efficacy of CAR-T cell therapy is 
      superior to pSOC in the real-world setting. Furthermore, axi-cel could be 
      superior in efficacy to tisa-cel, although more toxic, in this group of 
      refractory patients according to SCHOLAR-1 criteria.
CI  - Copyright (c) 2022 Bastos-Oreiro, Gutierrez, Reguera, Iacoboni, Lopez-Corral, 
      Terol, Ortiz-Maldonado, Sanz, Guerra-Dominguez, Bailen, Mussetti, Abrisqueta, 
      Hernani, Luzardo, Sancho, Delgado-Serrano, Salar, Grande, Bento, Gonzalez de 
      Villambrosia, Garcia-Belmonte, Sureda, Perez-Martinez, Barba, Kwon and Martin 
      Garcia-Sancho.
FAU - Bastos-Oreiro, Mariana
AU  - Bastos-Oreiro M
AD  - Hospita Universitario Gregorio Maranon, Instituto de Investigacion Sanitaria 
      Gregorio Maranon, Madrid, Spain.
FAU - Gutierrez, Antonio
AU  - Gutierrez A
AD  - Hospital Universitario Son Espases, Fundacio Institut d'Investigacio Sanitaria 
      Illes Balears (IdISBa), Palma de Mallorca, Spain.
FAU - Reguera, Juan Luis
AU  - Reguera JL
AD  - Hematology Department, Hospital Universitario Virgen del Rocio, Sevilla, Spain.
FAU - Iacoboni, Gloria
AU  - Iacoboni G
AD  - Hematology Department, Hospital Vall d' Hebron, Barcelona, Spain.
FAU - Lopez-Corral, Lucia
AU  - Lopez-Corral L
AD  - Hospital Universitario de Salamanca, Instituto de investigacion biomedica de 
      Salamanca (IDBAL), CIBERONC, Salamanca, Spain.
FAU - Terol, Maria Jose
AU  - Terol MJ
AD  - Hematology Department, Hospital Clinico Universitario de Valencia, Valencia, 
      Spain.
FAU - Ortiz-Maldonado, Valentin
AU  - Ortiz-Maldonado V
AD  - Hematology Department, Hospital Clinico Universitario de Barcelona, Barcelona, 
      Spain.
FAU - Sanz, Jaime
AU  - Sanz J
AD  - Hematology Department, Hospital Universitario La Fe de Valencia, Valencia, Spain.
FAU - Guerra-Dominguez, Luisa
AU  - Guerra-Dominguez L
AD  - Hospital Negrin, Las Palmas de Gran Canari, Las Palmas de Gran Canarias, Spain.
FAU - Bailen, Rebeca
AU  - Bailen R
AD  - Hospita Universitario Gregorio Maranon, Instituto de Investigacion Sanitaria 
      Gregorio Maranon, Madrid, Spain.
FAU - Mussetti, Alberto
AU  - Mussetti A
AD  - Institut Catala d'Oncologia-Hospitalet, Instituto de Investigacion Biomedica de 
      Bellvitge (IDIBELL), Universitat de Barcelona, Barcelona, Spain.
FAU - Abrisqueta, Pau
AU  - Abrisqueta P
AD  - Hematology Department, Hospital Vall d' Hebron, Barcelona, Spain.
FAU - Hernani, Rafael
AU  - Hernani R
AD  - Hematology Department, Hospital Clinico Universitario de Valencia, Valencia, 
      Spain.
FAU - Luzardo, Hugo
AU  - Luzardo H
AD  - Hospital Negrin, Las Palmas de Gran Canari, Las Palmas de Gran Canarias, Spain.
FAU - Sancho, Juan-Manuel
AU  - Sancho JM
AD  - Hematology Department, Campus ICO-Germans Trias i Pujol (ICO-IJC)-Hospital 
      Germans Trias i Pujol, Badalona, Spain.
FAU - Delgado-Serrano, Javier
AU  - Delgado-Serrano J
AD  - Hematology Department, Hospital Universitario Virgen del Rocio, Sevilla, Spain.
FAU - Salar, Antonio
AU  - Salar A
AD  - Hematology Department, Hospital del Mar, Barcelona, Spain.
FAU - Grande, Carlos
AU  - Grande C
AD  - Hematology Department, Hospital 12 de Octubre, Madrid, Spain.
FAU - Bento, Leyre
AU  - Bento L
AD  - Hospital Universitario Son Espases, Fundacio Institut d'Investigacio Sanitaria 
      Illes Balears (IdISBa), Palma de Mallorca, Spain.
FAU - Gonzalez de Villambrosia, Sonia
AU  - Gonzalez de Villambrosia S
AD  - Hematology Department, Hospital Universitario de Marques de Valdecillas, 
      Santander, Spain.
FAU - Garcia-Belmonte, Daniel
AU  - Garcia-Belmonte D
AD  - Hematology Department, Hospital Universitario de La Zarzuela, Madrid, Spain.
FAU - Sureda, Anna
AU  - Sureda A
AD  - Institut Catala d'Oncologia-Hospitalet, Instituto de Investigacion Biomedica de 
      Bellvitge (IDIBELL), Universitat de Barcelona, Barcelona, Spain.
FAU - Perez-Martinez, Antonio
AU  - Perez-Martinez A
AD  - Hematology Department, Hospital Universitario La Paz, Madrid, Spain.
FAU - Barba, Pere
AU  - Barba P
AD  - Hematology Department, Hospital Vall d' Hebron, Barcelona, Spain.
FAU - Kwon, Mi
AU  - Kwon M
AD  - Hospita Universitario Gregorio Maranon, Instituto de Investigacion Sanitaria 
      Gregorio Maranon, Madrid, Spain.
FAU - Martin Garcia-Sancho, Alejandro
AU  - Martin Garcia-Sancho A
AD  - Hospital Universitario de Salamanca, Instituto de investigacion biomedica de 
      Salamanca (IDBAL), CIBERONC, Salamanca, Spain.
LA  - eng
PT  - Journal Article
DEP - 20220712
PL  - Switzerland
TA  - Front Immunol
JT  - Frontiers in immunology
JID - 101560960
RN  - 0 (Antigens, CD19)
RN  - 0 (Receptors, Chimeric Antigen)
SB  - IM
MH  - Antigens, CD19
MH  - Humans
MH  - *Lymphoma, Large B-Cell, Diffuse/pathology
MH  - *Receptors, Chimeric Antigen/genetics
MH  - Retrospective Studies
MH  - T-Lymphocytes
PMC - PMC9336530
OTO - NOTNLM
OT  - CAR-T cell therapy
OT  - real world evidence (RWE)
OT  - refractory aggressive B cell lymphoma
OT  - scholar-1 criteria
OT  - standard of care (SOC)
COIS- The authors declare that the research was conducted in the absence of any 
      commercial or financial relationships that could be construed as a potential 
      conflict of interest.
EDAT- 2022/08/02 06:00
MHDA- 2022/08/03 06:00
PMCR- 2022/01/01
CRDT- 2022/08/01 03:51
PHST- 2022/01/15 00:00 [received]
PHST- 2022/05/27 00:00 [accepted]
PHST- 2022/08/01 03:51 [entrez]
PHST- 2022/08/02 06:00 [pubmed]
PHST- 2022/08/03 06:00 [medline]
PHST- 2022/01/01 00:00 [pmc-release]
AID - 10.3389/fimmu.2022.855730 [doi]
PST - epublish
SO  - Front Immunol. 2022 Jul 12;13:855730. doi: 10.3389/fimmu.2022.855730. eCollection 
      2022.