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Axicabtagene ciloleucel compared to tisagenlecleucel for the treatment of aggressive B-cell lymphomaKwon, Mi; Iacoboni, Gloria; Reguera, Juan Luis; Corral, Lucía López; Morales, Rafael Hernani; Ortiz-Maldonado, Valentín; Guerreiro, Manuel; Caballero, Ana Carolina; Domínguez, María Luisa Guerra; Pina, Jose Maria Sanchez; Mussetti, Alberto; Sancho, Juan Manuel; Bastos-Oreiro, Mariana; Catala, Eva; Delgado, Javier; Henriquez, Hugo Luzardo; Sanz, Jaime; Calbacho, María; Bailén, Rebeca; Carpio, Cecilia; Ribera, Jose Maria; Sureda, Anna; Briones, Javier; Hernandez-Boluda, Juan Carlos; Cebrián, Nuria Martínez; Martin, Jose Luis Diez; Martín, Alejandro; Barba, Pere
Haematologica (Roma), 01/2023, Letnik: 108, Številka: 1Journal Article
Axicabtagene ciloleucel (axi-cel) and tisagenlecleucel (tisa-cel) are CD19-targeted chimeric antigen receptor (CAR) T cells approved for relapsed/refractory (R/R) large B-cell lymphoma (LBCL). We performed a retrospective study to evaluate safety and efficacy of axi-cel and tisa-cel outside the setting of a clinical trial. Data from consecutive patients with R/R LBCL who underwent apheresis for axi-cel or tisa-cel were retrospectively collected from 12 Spanish centers. A total of 307 patients underwent apheresis for axi-cel (n=152) and tisa-cel (n=155) from November 2018 to August 2021, of which 261 (85%) received a CAR T infusion (88% and 82%, respectively). Median time from apheresis to infusion was 41 days for axi-cel and 52 days for tisa-cel (P=0.006). None of the baseline characteristics were significantly different between both cohorts. Both cytokine release syndrome and neurologic events (NE) were more frequent in the axi-cel group (88% vs. 73%, P=0.003, and 42% vs. 16%, P<0.001, respectively). Infections in the first 6 months post-infusion were also more common in patients treated with axi-cel (38% vs. 25%, P=0.033). Non-relapse mortality was not significantly different between the axi-cel and tisa-cel groups (7% and 4%, respectively, P=0.298). With a median follow-up of 9.2 months, median PFS and OS were 5.9 and 3 months, and 13.9 and 11.2 months for axi-cel and tisa-cel, respectively. The 12-month PFS and OS for axi-cel and tisa-cel were 41% and 33% (P=0.195), 51% and 47% (P=0.191), respectively. Factors associated with lower OS in the multivariate analysis were increased lactate dehydrogenase, ECOG ≥2 and progressive disease before lymphodepletion. Safety and efficacy results in our real-world experience were comparable with those reported in the pivotal trials. Patients treated with axi-cel experienced more toxicity but similar non-relapse mortality compared with those receiving tisa-cel. Efficacy was not significantly different between both products.
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JCR | SNIP | JCR | SNIP | JCR | SNIP | JCR | SNIP |
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