PMID- 35770532
OWN - NLM
STAT- MEDLINE
DCOM- 20230104
LR  - 20230203
IS  - 1592-8721 (Electronic)
IS  - 0390-6078 (Print)
IS  - 0390-6078 (Linking)
VI  - 108
IP  - 1
DP  - 2023 Jan 1
TI  - Axicabtagene ciloleucel compared to tisagenlecleucel for the treatment of 
      aggressive B-cell lymphoma.
PG  - 110-121
LID - 10.3324/haematol.2022.280805 [doi]
AB  - Axicabtagene ciloleucel (axi-cel) and tisagenlecleucel (tisa-cel) are 
      CD19-targeted chimeric antigen receptor (CAR) T cells approved for 
      relapsed/refractory (R/R) large B-cell lymphoma (LBCL). We performed a 
      retrospective study to evaluate safety and efficacy of axi-cel and tisa-cel 
      outside the setting of a clinical trial. Data from consecutive patients with R/R 
      LBCL who underwent apheresis for axi-cel or tisa-cel were retrospectively 
      collected from 12 Spanish centers. A total of 307 patients underwent apheresis 
      for axi-cel (n=152) and tisa-cel (n=155) from November 2018 to August 2021, of 
      which 261 (85%) received a CAR T infusion (88% and 82%, respectively). Median 
      time from apheresis to infusion was 41 days for axi-cel and 52 days for tisa-cel 
      (P=0.006). None of the baseline characteristics were significantly different 
      between both cohorts. Both cytokine release syndrome and neurologic events (NE) 
      were more frequent in the axi-cel group (88% vs. 73%, P=0.003, and 42% vs. 16%, 
      P<0.001, respectively). Infections in the first 6 months post-infusion were also 
      more common in patients treated with axi-cel (38% vs. 25%, P=0.033). Non-relapse 
      mortality was not significantly different between the axi-cel and tisa-cel groups 
      (7% and 4%, respectively, P=0.298). With a median follow-up of 9.2 months, median 
      PFS and OS were 5.9 and 3 months, and 13.9 and 11.2 months for axi-cel and 
      tisa-cel, respectively. The 12-month PFS and OS for axi-cel and tisa-cel were 41% 
      and 33% (P=0.195), 51% and 47% (P=0.191), respectively. Factors associated with 
      lower OS in the multivariate analysis were increased lactate dehydrogenase, ECOG 
      >/=2 and progressive disease before lymphodepletion. Safety and efficacy results in 
      our real-world experience were comparable with those reported in the pivotal 
      trials. Patients treated with axi-cel experienced more toxicity but similar 
      non-relapse mortality compared with those receiving tisa-cel. Efficacy was not 
      significantly different between both products.
FAU - Kwon, Mi
AU  - Kwon M
AD  - Department of Hematology, Hospital General Universitario Gregorio Maranon, 
      Madrid, Spain; Instituto de Investigacion Sanitaria Gregorio Maranon, Madrid. 
      mi.kwon@salud.madrid.org.
FAU - Iacoboni, Gloria
AU  - Iacoboni G
AD  - Department of Hematology, Vall d'Hebron University Hospital, Experimental 
      Hematology, Vall d'Hebron Institute of Oncology (VHIO), Vall d'Hebron Barcelona 
      Hospital Campus, Passeig Vall d'Hebron 119-129, 08035 Barcelona, Spain; 
      Department of Medicine, Universitat Autonoma de Barcelona, 08193 Bellaterra.
FAU - Reguera, Juan Luis
AU  - Reguera JL
AD  - Department of Hematology, Hospital Universitario Virgen del Rocio, Instituto de 
      Biomedicina de Sevilla, Sevilla.
FAU - Corral, Lucia Lopez
AU  - Corral LL
AD  - Department of Hematology, Hospital Clinico Universitario de Salamanca, IBSAL, 
      Salamanca.
FAU - Morales, Rafael Hernani
AU  - Morales RH
AD  - Department of Hematology, Hospital Clinico Universitario de Valencia, Instituto 
      de Investigacion Sanitaria INCLIVA, Valencia.
FAU - Ortiz-Maldonado, Valentin
AU  - Ortiz-Maldonado V
AD  - Department of Hematology, Hospital Clinic, Barcelona.
FAU - Guerreiro, Manuel
AU  - Guerreiro M
AD  - Department of Hematology, Hospital Universitario y Politecnico La Fe, Valencia.
FAU - Caballero, Ana Carolina
AU  - Caballero AC
AD  - Department of Hematology, Hospital de la Santa Creu i Sant Pau, Barcelona.
FAU - Dominguez, Maria Luisa Guerra
AU  - Dominguez MLG
AD  - Department of Hematology, Hospital Universitario de Gran Canaria Doctor Negrin, 
      Las Palmas de Gran Canaria.
FAU - Pina, Jose Maria Sanchez
AU  - Pina JMS
AD  - Department of Hematology, Hospital Universitario 12 de Octubre, Madrid.
FAU - Mussetti, Alberto
AU  - Mussetti A
AD  - Department of Hematology, Hospital Duran i Reynals, Instituto Catalan de 
      Oncologia, Barcelona.
FAU - Sancho, Juan Manuel
AU  - Sancho JM
AD  - Department of Hematology, Hospital Universitari Germans Trias i Pujol, Instituto 
      Catalan de Oncologia, Josep Carreras Research Institute, Badalona.
FAU - Bastos-Oreiro, Mariana
AU  - Bastos-Oreiro M
AD  - Department of Hematology, Hospital General Universitario Gregorio Maranon, 
      Madrid, Spain; Instituto de Investigacion Sanitaria Gregorio Maranon, Madrid.
FAU - Catala, Eva
AU  - Catala E
AD  - Department of Hematology, Vall d'Hebron University Hospital, Experimental 
      Hematology, Vall d'Hebron Institute of Oncology (VHIO), Vall d'Hebron Barcelona 
      Hospital Campus, Passeig Vall d'Hebron 119-129, 08035 Barcelona, Spain; 
      Department of Medicine, Universitat Autonoma de Barcelona, 08193 Bellaterra.
FAU - Delgado, Javier
AU  - Delgado J
AD  - Department of Hematology, Hospital Universitario Virgen del Rocio, Instituto de 
      Biomedicina de Sevilla, Sevilla.
FAU - Henriquez, Hugo Luzardo
AU  - Henriquez HL
AD  - Department of Hematology, Hospital Universitario de Gran Canaria Doctor Negrin, 
      Las Palmas de Gran Canaria.
FAU - Sanz, Jaime
AU  - Sanz J
AD  - Department of Hematology, Hospital Universitario y Politecnico La Fe, Valencia.
FAU - Calbacho, Maria
AU  - Calbacho M
AD  - Department of Hematology, Hospital Universitario 12 de Octubre, Madrid.
FAU - Bailen, Rebeca
AU  - Bailen R
AD  - Department of Hematology, Hospital General Universitario Gregorio Maranon, 
      Madrid, Spain; Instituto de Investigacion Sanitaria Gregorio Maranon, Madrid.
FAU - Carpio, Cecilia
AU  - Carpio C
AD  - Department of Hematology, Vall d'Hebron University Hospital, Experimental 
      Hematology, Vall d'Hebron Institute of Oncology (VHIO), Vall d'Hebron Barcelona 
      Hospital Campus, Passeig Vall d'Hebron 119-129, 08035 Barcelona, Spain; 
      Department of Medicine, Universitat Autonoma de Barcelona, 08193 Bellaterra.
FAU - Ribera, Jose Maria
AU  - Ribera JM
AD  - Department of Hematology, Hospital Universitari Germans Trias i Pujol, Instituto 
      Catalan de Oncologia, Josep Carreras Research Institute, Badalona.
FAU - Sureda, Anna
AU  - Sureda A
AD  - Department of Hematology, Hospital Duran i Reynals, Instituto Catalan de 
      Oncologia, Barcelona.
FAU - Briones, Javier
AU  - Briones J
AD  - Department of Hematology, Hospital de la Santa Creu i Sant Pau, Barcelona.
FAU - Hernandez-Boluda, Juan Carlos
AU  - Hernandez-Boluda JC
AD  - Department of Hematology, Hospital Clinico Universitario de Valencia, Instituto 
      de Investigacion Sanitaria INCLIVA, Valencia.
FAU - Cebrian, Nuria Martinez
AU  - Cebrian NM
AD  - Department of Hematology, Hospital Clinic, Barcelona.
FAU - Martin, Jose Luis Diez
AU  - Martin JLD
AD  - Department of Hematology, Hospital General Universitario Gregorio Maranon, 
      Madrid, Spain; Instituto de Investigacion Sanitaria Gregorio Maranon, Madrid, 
      Spain; Universidad Complutense de Madrid.
FAU - Martin, Alejandro
AU  - Martin A
AD  - Department of Hematology, Hospital Clinico Universitario de Salamanca, IBSAL, 
      Salamanca.
FAU - Barba, Pere
AU  - Barba P
AD  - Department of Hematology, Vall d'Hebron University Hospital, Experimental 
      Hematology, Vall d'Hebron Institute of Oncology (VHIO), Vall d'Hebron Barcelona 
      Hospital Campus, Passeig Vall d'Hebron 119-129, 08035 Barcelona, Spain; 
      Department of Medicine, Universitat Autonoma de Barcelona, 08193 Bellaterra.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20230101
PL  - Italy
TA  - Haematologica
JT  - Haematologica
JID - 0417435
RN  - 0 (Adaptor Proteins, Signal Transducing)
RN  - 0 (Antigens, CD19)
RN  - U2I8T43Y7R (axicabtagene ciloleucel)
RN  - Q6C9WHR03O (tisagenlecleucel)
SB  - IM
MH  - Humans
MH  - Adaptor Proteins, Signal Transducing
MH  - Antigens, CD19
MH  - *Immunotherapy, Adoptive/adverse effects
MH  - *Lymphoma, Large B-Cell, Diffuse/therapy
MH  - Retrospective Studies
PMC - PMC9827173
EDAT- 2022/07/01 06:00
MHDA- 2023/01/04 06:00
PMCR- 2022/06/30
CRDT- 2022/06/30 04:26
PHST- 2022/02/07 00:00 [received]
PHST- 2022/07/01 06:00 [pubmed]
PHST- 2023/01/04 06:00 [medline]
PHST- 2022/06/30 04:26 [entrez]
PHST- 2022/06/30 00:00 [pmc-release]
AID - 10.3324/haematol.2022.280805 [doi]
PST - epublish
SO  - Haematologica. 2023 Jan 1;108(1):110-121. doi: 10.3324/haematol.2022.280805.