PMID- 33932100
OWN - NLM
STAT- MEDLINE
DCOM- 20210719
LR  - 20210719
IS  - 2045-7634 (Electronic)
IS  - 2045-7634 (Linking)
VI  - 10
IP  - 10
DP  - 2021 May
TI  - Real-world evidence of tisagenlecleucel for the treatment of relapsed or 
      refractory large B-cell lymphoma.
PG  - 3214-3223
LID - 10.1002/cam4.3881 [doi]
AB  - 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.
CI  - (c) 2021 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.
FAU - Iacoboni, Gloria
AU  - Iacoboni G
AUID- ORCID: 0000-0003-0805-9288
AD  - Department of Hematology, University Hospital Vall d'Hebron, Barcelona, Spain.
AD  - Department of Medicine, Universitat Autonoma de Barcelona, Bellaterra, Spain.
AD  - Experimental Hematology, Vall d'Hebron Institute of Oncology (VHIO), Barcelona, 
      Spain.
FAU - Villacampa, Guillermo
AU  - Villacampa G
AD  - Oncology Data Science, Vall d'Hebron Institute of Oncology (VHIO), Barcelona, 
      Spain.
FAU - Martinez-Cibrian, Nuria
AU  - Martinez-Cibrian N
AD  - Department of Hematology, University Hospital Virgen del Rocio, Sevilla, Spain.
FAU - Bailen, Rebeca
AU  - Bailen R
AD  - Department of Hematology, Hospital General Universitario Gregorio Maranon, 
      Madrid, Spain.
AD  - Gregorio Maranon Health Research Institute (IiSGM), Madrid, Spain.
FAU - Lopez Corral, Lucia
AU  - Lopez Corral L
AD  - Hematology Department, Hospital Clinico Universitario de Salamanca, IBSAL, 
      CIBERONC, Salamanca, Spain.
AD  - Centro de Investigacion del Cancer-IBMCC, Salamanca, Spain.
FAU - Sanchez, Jose M
AU  - Sanchez JM
AD  - Hematology Department, Hospital 12 de Octubre, Madrid, Spain.
FAU - Guerreiro, Manuel
AU  - Guerreiro M
AD  - Department of Hematology, Hospital La Fe, Valencia, Spain.
FAU - Caballero, Ana Carolina
AU  - Caballero AC
AD  - Hematology Department, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.
AD  - Josep Carreras Leukaemia Research Institute, Barcelona, Spain.
FAU - Mussetti, Alberto
AU  - Mussetti A
AD  - Hematology Department, Institut Catala d'Oncologia, Hospital Duran i Reynals, 
      L'Hospitalet De Llobregat, Spain.
AD  - Institut d'Investigacio Biomedica de Bellvitge (IDIBELL), L'Hospitalet De 
      Llobregat, Barcelona, Spain.
FAU - Sancho, Juan-Manuel
AU  - Sancho JM
AUID- ORCID: 0000-0001-7168-6538
AD  - Hematology Department, ICO-IJC Hospital Germans Trias i Pujol, Barcelona, Spain.
FAU - Hernani, Rafael
AU  - Hernani R
AD  - Department of Hematology, Hospital Clinico Universitario de Valencia, Valencia, 
      Spain.
AD  - Instituto de Investigacion Sanitaria INCLIVA, Valencia, Spain.
FAU - Abrisqueta, Pau
AU  - Abrisqueta P
AD  - Department of Hematology, University Hospital Vall d'Hebron, Barcelona, Spain.
AD  - Department of Medicine, Universitat Autonoma de Barcelona, Bellaterra, Spain.
AD  - Experimental Hematology, Vall d'Hebron Institute of Oncology (VHIO), Barcelona, 
      Spain.
FAU - Solano, Carlos
AU  - Solano C
AD  - Department of Hematology, Hospital Clinico Universitario de Valencia, Valencia, 
      Spain.
AD  - Instituto de Investigacion Sanitaria INCLIVA, Valencia, Spain.
AD  - Department of Medicine, University of Valencia, Valencia, Spain.
FAU - Sureda, Anna
AU  - Sureda A
AD  - Hematology Department, Institut Catala d'Oncologia, Hospital Duran i Reynals, 
      L'Hospitalet De Llobregat, Spain.
AD  - Institut d'Investigacio Biomedica de Bellvitge (IDIBELL), L'Hospitalet De 
      Llobregat, Barcelona, Spain.
FAU - Briones, Javier
AU  - Briones J
AD  - Hematology Department, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.
AD  - Josep Carreras Leukaemia Research Institute, Barcelona, Spain.
FAU - Martin Garcia-Sancho, Alejandro
AU  - Martin Garcia-Sancho A
AD  - Hematology Department, Hospital Clinico Universitario de Salamanca, IBSAL, 
      CIBERONC, Salamanca, Spain.
AD  - Centro de Investigacion del Cancer-IBMCC, Salamanca, Spain.
FAU - Kwon, Mi
AU  - Kwon M
AD  - Department of Hematology, Hospital General Universitario Gregorio Maranon, 
      Madrid, Spain.
AD  - Gregorio Maranon Health Research Institute (IiSGM), Madrid, Spain.
FAU - Reguera-Ortega, Juan Luis
AU  - Reguera-Ortega JL
AD  - Department of Hematology, University Hospital Virgen del Rocio, Sevilla, Spain.
FAU - Barba, Pere
AU  - Barba P
AUID- ORCID: 0000-0001-7076-7969
AD  - Department of Hematology, University Hospital Vall d'Hebron, Barcelona, Spain.
AD  - Department of Medicine, Universitat Autonoma de Barcelona, Bellaterra, Spain.
AD  - Experimental Hematology, Vall d'Hebron Institute of Oncology (VHIO), Barcelona, 
      Spain.
CN  - GETH, GELTAMO Spanish Groups
LA  - eng
PT  - Journal Article
DEP - 20210501
PL  - United States
TA  - Cancer Med
JT  - Cancer medicine
JID - 101595310
RN  - 0 (Cytokines)
RN  - 0 (Receptors, Antigen, T-Cell)
RN  - 0 (Receptors, Chimeric Antigen)
RN  - Q6C9WHR03O (tisagenlecleucel)
SB  - IM
MH  - Aged
MH  - Cytokines/metabolism
MH  - Female
MH  - Humans
MH  - Leukapheresis/methods
MH  - Lymphoma, Large B-Cell, Diffuse/*drug therapy/metabolism
MH  - Male
MH  - Middle Aged
MH  - Neoplasm Recurrence, Local/*drug therapy/metabolism
MH  - Progression-Free Survival
MH  - Receptors, Antigen, T-Cell/*therapeutic use
MH  - Receptors, Chimeric Antigen/metabolism
MH  - Retrospective Studies
MH  - Standard of Care
PMC - PMC8124109
OTO - NOTNLM
OT  - clinical cancer research
OT  - clinical observations
OT  - hematological cancer
OT  - non-Hodgkin's lymphoma
COIS- G.I. declares having received honoraria from BMS/Celgene, Gilead, Novartis, 
      Janssen, and Roche, not related with this article. G.V. reported receiving 
      honoraria for speaker activities from Merck Sharp & Dohme and an advisory role 
      from Astrazeneca. A.M. declares having received Gilead research fundings and 
      honoraria from Novartis and Takeda. JM. S. declares having received honoraria 
      from Roche, Novartis, Gilead, Celgene, Janssen, Takeda, and Incyte; also 
      consulting for Roche, Novartis, Gilead, Celgene, Janssen, Incyte, Celltrion, and 
      Sandoz. P.A. has received honorarium for advisory and speaker faculty from 
      Janssen, Roche, Celgene, Abbvie, Gilead, and Astrazeneca. A.M.G-S. declares 
      having received honoraria from Roche, Celgene, Janssen, Servier, Gilead; 
      consulting fees from Roche, Celgene/BMS, Morphosys, Kyowa Kirin, Clinigen, Eusa 
      Pharma, Novartis, Gilead, Servier; research funding from Janssen. JL. R-O. 
      declares having received honoraria from Novartis, Kite/Gilead, BMS/Celgene. P.B. 
      declares having received honoraria from Amgen, Celgene, Gilead, Incyte, Jazz 
      Pharmaceuticals, MSD, Novartis, Pfizer, and Roche, not related with this article. 
      P.B. received funding from the Carlos III FIS16/01433 Health Institute, 
      Asociacion Espanola contra el Cancer (Ideas Semilla 2019) and a PERIS 2018-2020 
      grant from the Generalitat de Catalunya (BDNS357800), not related to this study.
EDAT- 2021/05/02 06:00
MHDA- 2021/07/20 06:00
PMCR- 2021/05/01
CRDT- 2021/05/01 08:42
PHST- 2021/03/09 00:00 [revised]
PHST- 2020/12/15 00:00 [received]
PHST- 2021/03/17 00:00 [accepted]
PHST- 2021/05/02 06:00 [pubmed]
PHST- 2021/07/20 06:00 [medline]
PHST- 2021/05/01 08:42 [entrez]
PHST- 2021/05/01 00:00 [pmc-release]
AID - CAM43881 [pii]
AID - 10.1002/cam4.3881 [doi]
PST - ppublish
SO  - Cancer Med. 2021 May;10(10):3214-3223. doi: 10.1002/cam4.3881. Epub 2021 May 1.