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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, MARIANA GUTIERREZ, ANTONIO Reguera, Juan Luís Iacoboni García-Calvo, Gloria Lopez Corral, Lucia Terol, M. Jose Barba Suñol, Pere Abrisqueta, Pau Institut Català de la Salut [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, Abrisqueta P, Barba P] Servei d’Hematologia, Vall d’Hebron Hospital Universitari, 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 Vall d'Hebron Barcelona Hospital Campus Cèl·lules T Cèl·lules B - Tumors - Tractament Teràpia cel·lular ANATOMY::Cells::Blood Cells::Leukocytes::Leukocytes, Mononuclear::Lymphocytes::T-Lymphocytes ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Biological Therapy::Cell- and Tissue-Based Therapy DISEASES::Neoplasms::Neoplasms by Histologic Type::Lymphoma::Lymphoma, Non-Hodgkin::Lymphoma, B-Cell::Lymphoma, Large B-Cell, Diffuse Other subheadings::Other subheadings::/therapy ANATOMÍA::células::células sanguíneas::leucocitos::leucocitos mononucleares::linfocitos::linfocitos T TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::terapia biológica::tratamientos basados en células y tejidos ENFERMEDADES::neoplasias::neoplasias por tipo histológico::linfoma::linfoma no Hodgkin::linfoma de células B::linfoma de células B grandes difuso Otros calificadores::Otros calificadores::/terapia CAR-T cell therapy; Real world evidence; B cell lymphoma Terapia con células CAR-T; Evidencia del mundo real; Linfoma de células B Teràpia amb cèl·lules CAR-T; Evidència del món real; Limfoma de cèl·lules B 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. 2023-05-18T07:16:52Z 2023-05-18T07:16:52Z 2022-07-12 info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion Bastos-Oreiro M, Gutierrez A, Reguera JL, Iacoboni G, López-Corral L, Terol MJ, et al. 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. Front Immunol. 2022 Jul 12;13:3148. 1664-3224 https://hdl.handle.net/11351/9555 10.3389/fimmu.2022.855730 35911769 000834262500001 http://hdl.handle.net/11351/9555 eng Frontiers in Immunology;13 https://doi.org/10.3389/fimmu.2022.855730 Attribution 4.0 International http://creativecommons.org/licenses/by/4.0/ info:eu-repo/semantics/openAccess application/pdf Frontiers Media Scientia