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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.
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.
Afiliación
  • Bastos-Oreiro M; Hospita Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón, Madrid, Spain.
  • Gutierrez A; Hospital Universitario Son Espases, Fundació Institut d'Investigació Sanitària Illes Balears (IdISBa), Palma de Mallorca, Spain.
  • Reguera JL; Hematology Department, Hospital Universitario Virgen del Rocío, Sevilla, Spain.
  • Iacoboni G; Hematology Department, Hospital Vall d' Hebron, Barcelona, Spain.
  • López-Corral L; Hospital Universitario de Salamanca, Instituto de investigación biomédica de Salamanca (IDBAL), CIBERONC, Salamanca, Spain.
  • Terol MJ; Hematology Department, Hospital Clínico Universitario de Valencia, Valencia, Spain.
  • Ortíz-Maldonado V; Hematology Department, Hospital Clinico Universitario de Barcelona, Barcelona, Spain.
  • Sanz J; Hematology Department, Hospital Universitario La Fé de Valencia, Valencia, Spain.
  • Guerra-Dominguez L; Hospital Negrin, Las Palmas de Gran Canari, Las Palmas de Gran Canarias, Spain.
  • Bailen R; Hospita Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón, Madrid, Spain.
  • Mussetti A; Institut Català d'Oncologia-Hospitalet, Instituto de Investigación Biomédica de Bellvitge (IDIBELL), Universitat de Barcelona, Barcelona, Spain.
  • Abrisqueta P; Hematology Department, Hospital Vall d' Hebron, Barcelona, Spain.
  • Hernani R; Hematology Department, Hospital Clínico Universitario de Valencia, Valencia, Spain.
  • Luzardo H; Hospital Negrin, Las Palmas de Gran Canari, Las Palmas de Gran Canarias, Spain.
  • Sancho JM; Hematology Department, Campus ICO-Germans Trias i Pujol (ICO-IJC)-Hospital Germans Trias i Pujol, Badalona, Spain.
  • Delgado-Serrano J; Hematology Department, Hospital Universitario Virgen del Rocío, Sevilla, Spain.
  • Salar A; Hematology Department, Hospital del Mar, Barcelona, Spain.
  • Grande C; Hematology Department, Hospital 12 de Octubre, Madrid, Spain.
  • Bento L; Hospital Universitario Son Espases, Fundació Institut d'Investigació Sanitària Illes Balears (IdISBa), Palma de Mallorca, Spain.
  • González de Villambrosía S; Hematology Department, Hospital Universitario de Marques de Valdecillas, Santander, Spain.
  • García-Belmonte D; Hematology Department, Hospital Universitario de La Zarzuela, Madrid, Spain.
  • Sureda A; Institut Català d'Oncologia-Hospitalet, Instituto de Investigación Biomédica de Bellvitge (IDIBELL), Universitat de Barcelona, Barcelona, Spain.
  • Pérez-Martínez A; Hematology Department, Hospital Universitario La Paz, Madrid, Spain.
  • Barba P; Hematology Department, Hospital Vall d' Hebron, Barcelona, Spain.
  • Kwon M; Hospita Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón, Madrid, Spain.
  • Martín García-Sancho A; Hospital Universitario de Salamanca, Instituto de investigación biomédica de Salamanca (IDBAL), CIBERONC, Salamanca, Spain.
Front Immunol ; 13: 855730, 2022.
Article en En | MEDLINE | ID: mdl-35911769
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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Linfoma de Células B Grandes Difuso / Receptores Quiméricos de Antígenos Tipo de estudio: Observational_studies / Prognostic_studies / Risk_factors_studies Límite: Humans Idioma: En Revista: Front Immunol Año: 2022 Tipo del documento: Article País de afiliación: España Pais de publicación: Suiza

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Linfoma de Células B Grandes Difuso / Receptores Quiméricos de Antígenos Tipo de estudio: Observational_studies / Prognostic_studies / Risk_factors_studies Límite: Humans Idioma: En Revista: Front Immunol Año: 2022 Tipo del documento: Article País de afiliación: España Pais de publicación: Suiza