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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
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 wi...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Frontiers Media S.A.
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9336530/ https://www.ncbi.nlm.nih.gov/pubmed/35911769 http://dx.doi.org/10.3389/fimmu.2022.855730 |
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author | Bastos-Oreiro, Mariana Gutierrez, Antonio Reguera, Juan Luís Iacoboni, Gloria López-Corral, Lucía Terol, María José Ortíz-Maldonado, Valentín Sanz, Jaime Guerra-Dominguez, Luisa Bailen, Rebeca Mussetti, Alberto Abrisqueta, Pau Hernani, Rafael Luzardo, Hugo Sancho, Juan-Manuel Delgado-Serrano, Javier Salar, Antonio Grande, Carlos Bento, Leyre González de Villambrosía, Sonia García-Belmonte, Daniel Sureda, Anna Pérez-Martínez, Antonio Barba, Pere Kwon, Mi Martín García-Sancho, Alejandro |
author_facet | Bastos-Oreiro, Mariana Gutierrez, Antonio Reguera, Juan Luís Iacoboni, Gloria López-Corral, Lucía Terol, María José Ortíz-Maldonado, Valentín Sanz, Jaime Guerra-Dominguez, Luisa Bailen, Rebeca Mussetti, Alberto Abrisqueta, Pau Hernani, Rafael Luzardo, Hugo Sancho, Juan-Manuel Delgado-Serrano, Javier Salar, Antonio Grande, Carlos Bento, Leyre González de Villambrosía, Sonia García-Belmonte, Daniel Sureda, Anna Pérez-Martínez, Antonio Barba, Pere Kwon, Mi Martín García-Sancho, Alejandro |
author_sort | Bastos-Oreiro, Mariana |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-9336530 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Frontiers Media S.A. |
record_format | MEDLINE/PubMed |
spelling | pubmed-93365302022-07-30 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 Bastos-Oreiro, Mariana Gutierrez, Antonio Reguera, Juan Luís Iacoboni, Gloria López-Corral, Lucía Terol, María José Ortíz-Maldonado, Valentín Sanz, Jaime Guerra-Dominguez, Luisa Bailen, Rebeca Mussetti, Alberto Abrisqueta, Pau Hernani, Rafael Luzardo, Hugo Sancho, Juan-Manuel Delgado-Serrano, Javier Salar, Antonio Grande, Carlos Bento, Leyre González de Villambrosía, Sonia García-Belmonte, Daniel Sureda, Anna Pérez-Martínez, Antonio Barba, Pere Kwon, Mi Martín García-Sancho, Alejandro Front Immunol Immunology 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. Frontiers Media S.A. 2022-07-12 /pmc/articles/PMC9336530/ /pubmed/35911769 http://dx.doi.org/10.3389/fimmu.2022.855730 Text en Copyright © 2022 Bastos-Oreiro, Gutierrez, Reguera, Iacoboni, López-Corral, Terol, Ortíz-Maldonado, Sanz, Guerra-Dominguez, Bailen, Mussetti, Abrisqueta, Hernani, Luzardo, Sancho, Delgado-Serrano, Salar, Grande, Bento, González de Villambrosía, García-Belmonte, Sureda, Pérez-Martínez, Barba, Kwon and Martín García-Sancho https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms. |
spellingShingle | Immunology Bastos-Oreiro, Mariana Gutierrez, Antonio Reguera, Juan Luís Iacoboni, Gloria López-Corral, Lucía Terol, María José Ortíz-Maldonado, Valentín Sanz, Jaime Guerra-Dominguez, Luisa Bailen, Rebeca Mussetti, Alberto Abrisqueta, Pau Hernani, Rafael Luzardo, Hugo Sancho, Juan-Manuel Delgado-Serrano, Javier Salar, Antonio Grande, Carlos Bento, Leyre González de Villambrosía, Sonia García-Belmonte, Daniel Sureda, Anna Pérez-Martínez, Antonio Barba, Pere Kwon, Mi Martín García-Sancho, Alejandro 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 |
title | 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 |
title_full | 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 |
title_fullStr | 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 |
title_full_unstemmed | 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 |
title_short | 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 |
title_sort | 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 |
topic | Immunology |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9336530/ https://www.ncbi.nlm.nih.gov/pubmed/35911769 http://dx.doi.org/10.3389/fimmu.2022.855730 |
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