Axicabtagene ciloleucel compared to tisagenlecleucel for the treatment of aggressive B-cell lymphoma
Kwon, Mi (Hospital General Universitario Gregorio Marañón)
Iacoboni, Gloria (Universitat Autònoma de Barcelona. Departament de Medicina)
Reguera-Ortega, Juan Luis (Instituto de Biomedicina de Sevilla)
Corral, Lucía López (Instituto de Investigación Biomédica de Salamanca)
Morales, Rafael Hernani (Hospital Clínic Universitari (València))
Ortiz-Maldonado, Valentín (Hospital Clínic i Provincial de Barcelona)
Guerreiro, Manuel (Hospital Universitari i Politècnic La Fe (València))
Caballero, Ana Carolina (Hospital de la Santa Creu i Sant Pau (Barcelona, Catalunya))
Domínguez, María Luisa Guerra (Hospital Universitario de Gran Canaria Dr. Negrín)
Pina, Jose Maria Sanchez (Hospital Universitario 12 de Octubre (Madrid))
Mussetti, Alberto (Institut Català d'Oncologia)
Sancho, Juan-Manuel (Institut Germans Trias i Pujol. Institut de Recerca contra la Leucèmia Josep Carreras)
Bastos, Mariana (Hospital General Universitario Gregorio Marañón)
Catala, Eva (Vall d'Hebron Institut d'Oncologia)
Delgado, Javier (Instituto de Biomedicina de Sevilla)
Henriquez, Hugo Luzardo (Hospital Universitario de Gran Canaria Dr. Negrín)
Sanz, Jaime (Hospital Universitari i Politècnic La Fe (València))
Calbacho, Maria (Hospital Universitario 12 de Octubre (Madrid))
Bailén, Rebeca (Hospital General Universitario Gregorio Marañón)
Carpio Segura, Cecilia del Carmen (Universitat Autònoma de Barcelona. Departament de Medicina)
Ribera Santasusana, Jose Maria (Institut Germans Trias i Pujol. Institut de Recerca contra la Leucèmia Josep Carreras)
Sureda, Anna (Institut Català d'Oncologia)
Briones Meijide, Javier (Hospital de la Santa Creu i Sant Pau (Barcelona, Catalunya))
Hernandez-Boluda, Juan Carlos (Hospital Clínic Universitari (València))
Cebrián, Nuria Martínez (Hospital Clínic i Provincial de Barcelona)
Martin, Jose Luis Diez (Universidad Complutense de Madrid)
Martín, Alejandro (Instituto de Investigación Biomédica de Salamanca)
Barba, Pere (Universitat Autònoma de Barcelona. Departament de Medicina)
Universitat Autònoma de Barcelona. Departament de Medicina

Data:	2022
Resum:	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 lympho-depletion. 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.
Ajuts:	Ministerio de Economía y Competitividad PI16/01433 Instituto de Salud Carlos III PI21/00197
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Publicat a:	Haematologica, Vol. 108 (january 2023) , p. 110-121, ISSN 1592-8721

DOI: 10.3324/haematol.2022.280805
PMID: 35770532

12 p, 927.8 KB

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