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Anti-CD19 CAR-T Cell Therapy in Elderly Patients: Multicentric Real-World Experience from GETH-TC/GELTAMO.
Bailén, Rebeca; Iacoboni, Gloria; Delgado, Javier; López-Corral, Lucía; Hernani-Morales, Rafael; Ortiz-Maldonado, Valentín; Guerreiro, Manuel; Caballero, Ana Carolina; Guerra-Domínguez, María Luisa; Sánchez-Pina, Jose Maria; Peña, Marta; Torrent, Anna; Pérez-Martínez, Antonio; Bastos-Oreiro, Mariana; Reguera-Ortega, Juan Luis; Martín, Alejandro; Hernandez-Boluda, Juan Carlos; Martínez-Cibrián, Nuria; Sanz, Jaime; Briones, Javier; Henriquez, Hugo Luzardo; Calbacho, María; Mussetti, Alberto; Sancho, Juan Manuel; Barba, Pere; Kwon, Mi.
Afiliação
  • Bailén R; Department of Hematology, Hospital General Universitario Gregorio Marañón, Madrid, Spain.; Gregorio Marañón Health Research Institute, Madrid, Spain.
  • Iacoboni G; Department of Hematology, Vall d'Hebron University Hospital, Experimental Hematology, Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain.; Department of Medicine, Universitat Autònoma de Barcelona, Bellaterra, Spain.
  • Delgado J; Department of Haematology, Hospital Universitario Virgen del Rocío, Institute of Biomedicine of Seville (IBiS/CSIC/CIBERONC), University of Seville, Seville, Spain.
  • López-Corral L; Department of Hematology, Hospital Clínico Universitario de Salamanca, IBSAL, Salamanca, Spain.
  • Hernani-Morales R; Department of Hematology, Hospital Clínico Universitario de Valencia, Instituto de Investigación Sanitaria INCLIVA, Valencia, Spain.
  • Ortiz-Maldonado V; Department of Haematology, Hospital Clínic, Barcelona, Spain.
  • Guerreiro M; Department of Hematology, Hospital Universitario y Politécnico La Fe, Valencia, Spain.
  • Caballero AC; Department of Hematology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.
  • Guerra-Domínguez ML; Department of Hematology, Hospital Universitario de Gran Canaria Doctor Negrín, Las Palmas de Gran Canaria, Spain.
  • Sánchez-Pina JM; Department of Hematology, Hospital Universitario 12 de Octubre, Madrid, Spain.
  • Peña M; Department of Hematology, Hospital Duran i Reynals, Instituto Catalán de Oncología, IDIBELL, Barcelona, Spain.
  • Torrent A; Department of Hematology, Hospital Universitari Germans Trias i Pujol, Badalona, Spain.
  • Pérez-Martínez A; Department of Paediatric Hemato-Oncology, Hospital Universitario La Paz, Madrid, Spain.
  • Bastos-Oreiro M; Department of Hematology, Hospital General Universitario Gregorio Marañón, Madrid, Spain.; Gregorio Marañón Health Research Institute, Madrid, Spain.; Universidad Complutense de Madrid, Spain.
  • Reguera-Ortega JL; Department of Haematology, Hospital Universitario Virgen del Rocío, Institute of Biomedicine of Seville (IBiS/CSIC/CIBERONC), University of Seville, Seville, Spain.
  • Martín A; Department of Hematology, Hospital Clínico Universitario de Salamanca, IBSAL, Salamanca, Spain.
  • Hernandez-Boluda JC; Department of Hematology, Hospital Clínico Universitario de Valencia, Instituto de Investigación Sanitaria INCLIVA, Valencia, Spain.
  • Martínez-Cibrián N; Department of Haematology, Hospital Clínic, Barcelona, Spain.
  • Sanz J; Department of Hematology, Hospital Universitario y Politécnico La Fe, Valencia, Spain.
  • Briones J; Department of Hematology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.
  • Henriquez HL; Department of Hematology, Hospital Universitario de Gran Canaria Doctor Negrín, Las Palmas de Gran Canaria, Spain.
  • Calbacho M; Department of Hematology, Hospital Universitario 12 de Octubre, Madrid, Spain.
  • Mussetti A; Department of Hematology, Hospital Duran i Reynals, Instituto Catalán de Oncología, IDIBELL, Barcelona, Spain.
  • Sancho JM; Department of Hematology, Hospital Universitari Germans Trias i Pujol, Badalona, Spain.
  • Barba P; Department of Hematology, Vall d'Hebron University Hospital, Experimental Hematology, Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain.; Department of Medicine, Universitat Autònoma de Barcelona, Bellaterra, Spain.
  • Kwon M; Department of Hematology, Hospital General Universitario Gregorio Marañón, Madrid, Spain.; Gregorio Marañón Health Research Institute, Madrid, Spain.; Universidad Complutense de Madrid, Spain.. Electronic address: mi.kwon@salud.madrid.org.
Transplant Cell Ther ; 30(10): 988.e1-988.e11, 2024 Oct.
Article em En | MEDLINE | ID: mdl-39069076
ABSTRACT
Chimeric antigen receptor (CAR)-T cell therapy is approved for the treatment of relapsed/refractory (R/R) large B cell lymphoma (LBCL). However, elderly patients might not be candidates for this therapy due to its toxicity, and criteria for candidate selection are lacking. Our aim was to analyze efficacy and toxicity results of CAR-T cell therapy in the population of patients 70 years and older as compared to those obtained in younger patients in the real-world setting. A multicentric retrospective study was performed including patients with R/R aggressive LBCL who received commercial CAR-T cell therapy with either tisagenlecleucel or axicabtagene ciloleucel within the Spanish Group of Hematopoietic Transplant and Cell Therapy/Spanish Group of Lymphomas and Autologous Transplant (GETH-TC/GELTAMO) centers between 2019 and 2023. As of August 2023, 442 adult patients with aggressive LBCL underwent apheresis for CAR-T cell therapy as third or subsequent line and follow-up data was collected. Of 412 infused patients, 71 (17%) were 70 years or older. Baseline characteristics, product selection, and characteristics at apheresis (including disease status, Ann Arbor stage, revised international prognosis index (R-IPI), bulky disease, lactate dehydrogenase [LDH] and ECOG [Eastern Cooperative Group performance status]) were comparable between groups. Median time from both approval to infusion and apheresis to infusion did not differ. No differences were found between groups in overall and complete response rates at 1 and 3 months. With a median follow-up of 12.2 months (range 1-44), 12-month progression-free survival (PFS) and overall survival (OS) were comparable between groups (35.2% in <70 years vs. 35.9% in ≥70 years (P = .938) and 51.1% and 52.1% (P = .885), respectively). Age ≥70 years did not affect PFS (hazard ratio (HR) 0.98, P = .941) and OS (HR 0.97, P = .890) in the univariate and multivariate analysis. Cytokine release syndrome (CRS) was observed in 82% of patients <70 years old and 84.5% in ≥ 70 years old (P = .408). Grade ≥3 CRS was more frequent in the older group (5% vs. 15%, P = .002). In the multivariate analysis, age ≥70 years was associated with an increased risk of grade ≥3 CRS (OR 3.7, P = .013). No differences were observed in terms of overall neurotoxicity (35% vs. 42%, P = .281) or grade ≥3 (12% vs. 17%, P = .33). The proportion of patients with infections, admission to the intensive care unit within the first month, and non-relapse mortality were similar between both groups. CAR-T cell therapy in patients older than 70 years showed similar efficacy to that observed in younger patients in the real-world setting. However, age ≥70 years was an independent risk factor for grades 3-4 CRS. The need for additional strategies to reduce toxicity in this population should be addressed in future studies.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Imunoterapia Adotiva Limite: Adult / Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Revista: Transplant Cell Ther / Transplantation and cellular therapy (Online) Ano de publicação: 2024 Tipo de documento: Article País de afiliação: Espanha

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Imunoterapia Adotiva Limite: Adult / Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Revista: Transplant Cell Ther / Transplantation and cellular therapy (Online) Ano de publicação: 2024 Tipo de documento: Article País de afiliação: Espanha