Real-world evidence of tisagenlecleucel for the treatment of relapsed or refractory large B-cell lymphoma
Por:
Iacoboni, G, Villacampa, G, Martinez-Cibrian, N, Bailen, R, Corral, LL, Sanchez, JM, Guerreiro, M, Caballero, AC, Mussetti, A, Sancho, JM, Hernani, R, Abrisqueta, P, Solano, C, Sureda, A, Briones, J, Garcia-Sancho, AM, Kwon, M, Reguera-Ortega, JL and Barba, P
Publicada:
1 may 2021
Ahead of Print:
1 may 2021
Resumen:
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.
Filiaciones:
Iacoboni, G:
Univ Hosp Vall dHebron, Dept Hematol, Barcelona, Spain
Univ Autonoma Barcelona, Dept Med, Bellaterra, Spain
Vall dHebron Inst Oncol VHIO, Expt Hematol, Barcelona, Spain
Villacampa, G:
Vall dHebron Inst Oncol VHIO, Oncol Data Sci, Barcelona, Spain
Martinez-Cibrian, N:
Univ Hosp Virgen Rocio, Dept Hematol, Seville, Spain
Bailen, R:
Hosp Gen Univ Gregorio Maranon, Dept Hematol, Madrid, Spain
Gregorio Maranon Hlth Res Inst IiSGM, Madrid, Spain
Corral, LL:
Hosp Clin Univ Salamanca, Hematol Dept, CIBERONC, IBSAL, Salamanca, Spain
Ctr Invest Canc IBMCC, Salamanca, Spain
Sanchez, JM:
Hosp 12 Octubre, Hematol Dept, Madrid, Spain
Guerreiro, M:
Hosp La Fe, Dept Hematol, Valencia, Spain
Caballero, AC:
Hosp Santa Creu & Sant Pau, Hematol Dept, Barcelona, Spain
Josep Carreras Leukaemia Res Inst, Barcelona, Spain
Mussetti, A:
Hosp Duran & Reynals, Inst Catala Oncol, Hematol Dept, Lhospitalet De Llobregat, Spain
Inst Invest Biomed Bellvitge IDIBELL, Barcelona, Spain
:
ICO IJC Hosp Germans Trias & Pujol, Hematol Dept, Barcelona, Spain
Hernani, R:
Hosp Clin Univ Valencia, Dept Hematol, Valencia, Spain
Inst Invest Sanitaria INCLIVA, Valencia, Spain
Abrisqueta, P:
Univ Hosp Vall dHebron, Dept Hematol, Barcelona, Spain
Univ Autonoma Barcelona, Dept Med, Bellaterra, Spain
Vall dHebron Inst Oncol VHIO, Expt Hematol, Barcelona, Spain
Solano, C:
Hosp Clin Univ Valencia, Dept Hematol, Valencia, Spain
Inst Invest Sanitaria INCLIVA, Valencia, Spain
Univ Valencia, Dept Med, Valencia, Spain
Sureda, A:
Hosp Duran & Reynals, Inst Catala Oncol, Hematol Dept, Lhospitalet De Llobregat, Spain
Inst Invest Biomed Bellvitge IDIBELL, Barcelona, Spain
Briones, J:
Hosp Santa Creu & Sant Pau, Hematol Dept, Barcelona, Spain
Josep Carreras Leukaemia Res Inst, Barcelona, Spain
Garcia-Sancho, AM:
Hosp Clin Univ Salamanca, Hematol Dept, CIBERONC, IBSAL, Salamanca, Spain
Ctr Invest Canc IBMCC, Salamanca, Spain
Kwon, M:
Hosp Gen Univ Gregorio Maranon, Dept Hematol, Madrid, Spain
Gregorio Maranon Hlth Res Inst IiSGM, Madrid, Spain
Reguera-Ortega, JL:
Univ Hosp Virgen Rocio, Dept Hematol, Seville, Spain
Barba, P:
Univ Hosp Vall dHebron, Dept Hematol, Barcelona, Spain
Univ Autonoma Barcelona, Dept Med, Bellaterra, Spain
Vall dHebron Inst Oncol VHIO, Expt Hematol, Barcelona, Spain
Green Published, gold
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