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Real-World Evidence of Tisagenlecleucel for the Treatment of Relapsed or Refractory Large B-Cell Lymphoma.

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Real-World Evidence of Tisagenlecleucel for the Treatment of Relapsed or Refractory Large B-Cell Lymphoma.

dc.contributor.author	Iacoboni, Gloria
dc.contributor.author	Villacampa, Guillermo
dc.contributor.author	Martinez-Cibrian, Nuria
dc.contributor.author	Bailén, Rebeca
dc.contributor.author	Lopez-Corral, Lucia
dc.contributor.author	Sanchez, Jose M.
dc.contributor.author	Guerreiro, Manuel
dc.contributor.author	Caballero, Ana Carolina
dc.contributor.author	Mussetti, Alberto
dc.contributor.author	Sancho, Juan Manuel
dc.contributor.author	Hernani Morales, Rafael
dc.contributor.author	Abrisqueta, Pau
dc.contributor.author	Solano Vercet, Carlos
dc.contributor.author	Sureda, Anna
dc.contributor.author	Briones, Javier
dc.contributor.author	Martin Garcia-Sancho, Alejandro
dc.contributor.author	Kwon, Mi
dc.contributor.author	Reguera Ortega, Juan Luis
dc.contributor.author	Barba, Pere
dc.date.accessioned	2022-09-05T10:29:48Z
dc.date.available	2022-09-05T10:29:48Z
dc.date.issued	2021
dc.identifier.citation	Iacoboni, Gloria Villacampa, Guillermo Martinez-Cibrian, Nuria Bailén, Rebeca Lopez-Corral, Lucia Sanchez, Jose M. Guerreiro, Manuel Caballero, Ana Carolina Mussetti, Alberto Sancho, Juan Manuel Hernani Morales, Rafael Abrisqueta, Pau Solano Vercet, Carlos Sureda, Anna Briones, Javier Martin Garcia-Sancho, Alejandro Kwon, Mi Reguera Ortega, Juan Luis Barba, Pere 2021 Real-World Evidence of Tisagenlecleucel for the Treatment of Relapsed or Refractory Large B-Cell Lymphoma. Cancer Medicine 3214 3223
dc.identifier.uri	https://hdl.handle.net/10550/83709
dc.description.abstract	Tisagenlecleucel (tisa-cel) is a second-generation autologous CD19-targeted chimeric antigen receptor (CAR) T-cell therapy approved for relapsed/refractory (R/R) large B-cell lymphoma (LBCL). The approval was based on the results of phase II JULIET trial, with a best overall response rate (ORR) and complete response (CR) rate in infused patients of 52% and 40%, respectively. We report outcomes with tisa-cel in the standard-of-care (SOC) setting for R/R LBCL. Data from all patients with R/R LBCL who underwent leukapheresis from December 2018 until June 2020 with the intent to receive SOC tisa-cel were retrospectively collected at 10 Spanish institutions. Toxicities were graded according to ASTCT criteria and responses were assessed as per Lugano 2014 classification. Of 91 patients who underwent leukapheresis, 75 (82%) received tisa-cel therapy. Grade 3 or higher cytokine release syndrome and neurotoxicity occurred in 5% and 1%, respectively; non-relapse mortality was 4%. Among the infused patients, best ORR and CR were 60% and 32%, respectively, with a median duration of response of 8.9 months. With a median follow-up of 14.1 months from CAR T-cell infusion, median progression-free survival and overall survival were 3 months and 10.7 months, respectively. At 12 months, patients in CR at first disease evaluation had a PFS of 87% and OS of 93%. Patients with an elevated lactate dehydrogenase showed a shorter PFS and OS on multivariate analysis. Treatment with tisa-cel for patients with relapsed/refractory LBCL in a European SOC setting showed a manageable safety profile and durable complete responses.
dc.language.iso	eng
dc.relation.ispartof	Cancer Medicine, 2021, p. 3214-3223
dc.subject	Patologia
dc.subject	Càncer
dc.title	Real-World Evidence of Tisagenlecleucel for the Treatment of Relapsed or Refractory Large B-Cell Lymphoma.
dc.type	journal article	es_ES
dc.date.updated	2022-09-05T10:29:48Z
dc.identifier.doi	10.1002/cam4.3881
dc.identifier.idgrec	144115
dc.rights.accessRights	open access	es_ES