1. Real‐world evidence of tisagenlecleucel for the treatment of relapsed or refractory large B‐cell lymphoma
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Lucía López Corral, Anna Sureda, Carlos Solano, Pau Abrisqueta, Juan-Manuel Sancho, Pere Barba, Guillermo Villacampa, Javier Briones, Rafael Hernani, Mi Kwon, Geltamo Spanish Groups Geth, Manuel Guerreiro, Gloria Iacoboni, José María Raya Sánchez, Alberto Mussetti, Ana Carolina Caballero, Alejandro Martin Garcia-Sancho, Juan Luis Reguera-Ortega, Rebeca Bailén, Nuria Martínez-Cibrian, Institut Català de la Salut, [Iacoboni G, Abrisqueta P, Barba P] Servei d’Hematologia, Vall d'Hebron Hospital Universitari, Barcelona, Spain. Departament de Medicina, Universitat Autònoma de Barcelona, Bellaterra, Spain. Experimental Hematology, Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. [Villacampa G] Oncology Data Science, Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. [Martinez-Cibrian N] Department of Hematology, University Hospital Virgen del Rocio, Sevilla, Spain. [Bailén R] Department of Hematology, Hospital General Universitario Gregorio Marañón, Madrid, Spain. Gregorio Marañón Health Research Institute (IiSGM), Madrid, Spain. [Lopez Corral L] Hematology Department, Hospital Clínico Universitario de Salamanca, IBSAL, CIBERONC, Salamanca, Spain. Centro de Investigación del Cáncer-IBMCC, Salamanca, Spain. [Sanchez JM] Hematology Department, Hospital 12 de Octubre, Madrid, Spain, and Vall d'Hebron Barcelona Hospital Campus
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Male ,0301 basic medicine ,aminoácidos, péptidos y proteínas::proteínas::proteínas de membranas::receptores de superficie celular::receptores inmunológicos::receptores de antígenos::receptores de antígenos de linfocitos T [COMPUESTOS QUÍMICOS Y DROGAS] ,Cancer Research ,non‐Hodgkin's lymphoma ,Best Overall Response ,hematological cancer ,Other subheadings::Other subheadings::/drug therapy [Other subheadings] ,Non- Hodgkin's lymphoma ,Gastroenterology ,0302 clinical medicine ,Medicine research ,Other subheadings::/therapeutic use [Other subheadings] ,Càncer ,B-cell lymphoma ,RC254-282 ,Cancer ,Original Research ,Receptors, Chimeric Antigen ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,non‐ ,Standard of Care ,Middle Aged ,Patologia ,Hodgkin&apos ,Progression-Free Survival ,Cytokine release syndrome ,clinical cancer research ,Oncology ,neoplasias::neoplasias por tipo histológico::linfoma::linfoma no Hodgkin::linfoma de células B::linfoma de células B grandes difuso [ENFERMEDADES] ,030220 oncology & carcinogenesis ,Cytokines ,Female ,Lymphoma, Large B-Cell, Diffuse ,non-Hodgkin's lymphoma ,medicine.medical_specialty ,Receptors, Antigen, T-Cell ,Cèl·lules B - Tumors - Tractament ,Otros calificadores::Otros calificadores::/farmacoterapia [Otros calificadores] ,Investigació mèdica ,Real world evidence ,03 medical and health sciences ,s lymphoma ,Neoplasms::Neoplasms by Histologic Type::Lymphoma::Lymphoma, Non-Hodgkin::Lymphoma, B-Cell::Lymphoma, Large B-Cell, Diffuse [DISEASES] ,Refractory ,clinical observations ,Internal medicine ,medicine ,Humans ,Radiology, Nuclear Medicine and imaging ,Leukapheresis ,Amino Acids, Peptides, and Proteins::Proteins::Membrane Proteins::Receptors, Cell Surface::Receptors, Immunologic::Receptors, Antigen::Receptors, Antigen, T-Cell [CHEMICALS AND DRUGS] ,Aged ,Retrospective Studies ,Otros calificadores::/uso terapéutico [Otros calificadores] ,business.industry ,Teràpia cel·lular ,Clinical Cancer Research ,medicine.disease ,Malaltia de Hodgkin ,Non-Hodgkin's lymphoma ,Lymphoma ,030104 developmental biology ,Hodgkin's disease ,Neoplasm Recurrence, Local ,business - 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., This article provides real‐world European data on the results of relapsed/refractory large B‐cell lymphoma patients treated with tisagenlecleucel.
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- 2021
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