Bastos Oreiro, MarianaGutiérrez García, Antonio ManuelReguera, Juan LuísIacoboni, GloriaLópez Corral, LucíaTerol, María JoséOrtíz Maldonado, ValentínSanz, JaimeGuerra Domínguez, LuisaBailen, RebecaMussetti, AlbertoAbrisqueta Costa, PauHernani, RafaelLuzardo, HugoSancho, Juan ManuelDelgado Serrano, JavierSalar, AntonioGrande, CarlosBento, LeyreGonzález de Villambrosía, SoniaGarcía Belmonte, DanielSureda, AnnaPérez Martínez, AntonioBarba, PereKwon, MiMartín García Sancho, Alejandro2022-09-122022-09-122022-07-121664-3224https://hdl.handle.net/2445/188928Real-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.11 p.application/pdfengcc by (c) Bastos Oreiro, Mariana et al., 2022http://creativecommons.org/licenses/by/3.0/es/LimfomesTeràpia cel·lularCèl·lules BLymphomasCellular therapyB cellsinfo:eu-repo/semantics/article2022-08-16info:eu-repo/semantics/openAccess35911769