Commercial anti-CD19 CAR T cell therapy for patients with relapsed/refractory aggressive B cell lymphoma in a European center.

Szczegóły
Abstrakt

Tytuł:: Commercial anti-CD19 CAR T cell therapy for patients with relapsed/refractory aggressive B cell lymphoma in a European center.
Autorzy:: Sesques P; Department of Hematology, Hospices Civils de Lyon, Lyon Sud Hospital, Pierre-Bénite, France.; Claude Bernard Lyon 1 University, Lyon, France.
Ferrant E; Department of Hematology, Hospices Civils de Lyon, Lyon Sud Hospital, Pierre-Bénite, France.
Safar V; Department of Hematology, Hospices Civils de Lyon, Lyon Sud Hospital, Pierre-Bénite, France.
Wallet F; Department of Critical Care, Hospices Civils de Lyon, Lyon Sud Hospital, Pierre-Bénite, France.
Tordo J; Department of Nuclear Medicine, Hospices Civils de Lyon, Lyon Sud Hospital, Pierre-Bénite, France.
Dhomps A; Department of Nuclear Medicine, Hospices Civils de Lyon, Lyon Sud Hospital, Pierre-Bénite, France.
Karlin L; Department of Hematology, Hospices Civils de Lyon, Lyon Sud Hospital, Pierre-Bénite, France.
Brisou G; Department of Hematology, Hospices Civils de Lyon, Lyon Sud Hospital, Pierre-Bénite, France.; Claude Bernard Lyon 1 University, Lyon, France.
Vercasson M; Department of Hematology, Hospices Civils de Lyon, Lyon Sud Hospital, Pierre-Bénite, France.
Hospital-Gustem C; Department of Hematology, Hospices Civils de Lyon, Lyon Sud Hospital, Pierre-Bénite, France.
Schwiertz V; Department of Pharmacy, Hospices Civils de Lyon, Lyon Sud Hospital, Pierre-Bénite, France.
Ranchon F; Claude Bernard Lyon 1 University, Lyon, France.; Department of Pharmacy, Hospices Civils de Lyon, Lyon Sud Hospital, Pierre-Bénite, France.
Rioufol C; Claude Bernard Lyon 1 University, Lyon, France.; Department of Pharmacy, Hospices Civils de Lyon, Lyon Sud Hospital, Pierre-Bénite, France.
Choquet M; Department of Hematology, Hospices Civils de Lyon, Lyon Sud Hospital, Pierre-Bénite, France.
Sujobert P; Claude Bernard Lyon 1 University, Lyon, France.; Department of Hematology Laboratory, Hospices Civils de Lyon, Lyon Sud Hospital, Pierre-Bénite, France.; Lyon Cancer Research Center, INSERM U1052 and CNRS UMR5286, Lyon, France.
Ghergus D; Department of Hematology, Hospices Civils de Lyon, Lyon Sud Hospital, Pierre-Bénite, France.
Bouafia F; Department of Hematology, Hospices Civils de Lyon, Lyon Sud Hospital, Pierre-Bénite, France.
Golfier C; Department of Hematology, Hospices Civils de Lyon, Lyon Sud Hospital, Pierre-Bénite, France.; Claude Bernard Lyon 1 University, Lyon, France.
Lequeu H; Department of Hematology, Hospices Civils de Lyon, Lyon Sud Hospital, Pierre-Bénite, France.
Lazareth A; Department of Hematology, Hospices Civils de Lyon, Lyon Sud Hospital, Pierre-Bénite, France.
Novelli S; Lyon Cancer Research Center, INSERM U1052 and CNRS UMR5286, Lyon, France.
Devic P; Department of Neurology, Hospices Civils de Lyon, Lyon Sud Hospital, Pierre-Bénite, France.
Traverse Glehen A; Claude Bernard Lyon 1 University, Lyon, France.; Lyon Cancer Research Center, INSERM U1052 and CNRS UMR5286, Lyon, France.; Department of Pathology, Hospices Civils de Lyon, Lyon Sud Hospital, Pierre-Bénite, France.
Viel S; Claude Bernard Lyon 1 University, Lyon, France.; Department of Biological Immunology, Hospices Civils de Lyon, Lyon Sud Hospital, Lyon, France.; International Center for Research in Infectious Diseases, INSERM U1111 and CNRS UMR5308, Lyon, France.
Venet F; Claude Bernard Lyon 1 University, Lyon, France.; Department of Clinical Immunology, Hospices Civils de Lyon, Edouard Herriot Hospital, Lyon, France.
Mialou V; Department of Biology and Therapy, Etablissement Français du Sang Auvergne-Rhône-Alpes, Decines-Charpieu, France.
Hequet O; Department of Biology and Therapy, Etablissement Français du Sang Auvergne-Rhône-Alpes, Decines-Charpieu, France.
Chauchet A; Department of Hematology, Besançon University Hospital, Besançon, France.
Arkam Y; Department of Hematology, Hopital Emile Muller, Mulhouse, France.
Nicolas-Virelizier E; Department of Hematology, Centre Léon Bérard, Lyon, France.
Peyrade F; Department of Hematology, Centre Antoine Lacassagne, Nice, France.
Cavalieri D; Department of Hematology, Clermont Ferrand University Hospital, Clermont Ferrand, France.
Ader F; Department of Infectious Disease, Hospices Civils de Lyon, Croix Rousse Hospital, Lyon, France.
Ghesquières H; Department of Hematology, Hospices Civils de Lyon, Lyon Sud Hospital, Pierre-Bénite, France.; Claude Bernard Lyon 1 University, Lyon, France.; Lyon Cancer Research Center, INSERM U1052 and CNRS UMR5286, Lyon, France.
Salles G; Department of Hematology, Hospices Civils de Lyon, Lyon Sud Hospital, Pierre-Bénite, France.; Claude Bernard Lyon 1 University, Lyon, France.; Lyon Cancer Research Center, INSERM U1052 and CNRS UMR5286, Lyon, France.
Bachy E; Department of Hematology, Hospices Civils de Lyon, Lyon Sud Hospital, Pierre-Bénite, France.; Claude Bernard Lyon 1 University, Lyon, France.; Lyon Cancer Research Center, INSERM U1052 and CNRS UMR5286, Lyon, France.
Źródło:: American journal of hematology [Am J Hematol] 2020 Nov; Vol. 95 (11), pp. 1324-1333. Date of Electronic Publication: 2020 Aug 25.
Typ publikacji:: Clinical Trial; Journal Article
Język:: English
Imprint Name(s):: Publication: New York Ny : Wiley-Blackwell
Original Publication: New York, Liss.
MeSH Terms:: Immunotherapy, Adoptive*
Lymphoma, Large B-Cell, Diffuse*/blood
Lymphoma, Large B-Cell, Diffuse*/mortality
Lymphoma, Large B-Cell, Diffuse*/therapy
Antigens, CD19/*blood
Antigens, Neoplasm/*blood
Adult ; Aged ; Disease-Free Survival ; Female ; France/epidemiology ; Humans ; Male ; Middle Aged ; Retrospective Studies ; Survival Rate
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Substance Nomenclature:: 0 (Antigens, CD19)
0 (Antigens, Neoplasm)
0 (CD19 molecule, human)
Entry Date(s):: Date Created: 20200804 Date Completed: 20201229 Latest Revision: 20201229
Update Code:: 20240105
DOI:: 10.1002/ajh.25951
PMID:: 32744738
: Czasopismo naukowe

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Two autologous anti-CD19 chimeric antigen receptors (CAR) T cells (axicabtagene ciloleucel [axi-cel] and tisagenlecleucel [tisa-cel]) are commercially approved in Europe for relapsed/refractory (R/R) diffuse large B cell lymphoma (DLBCL). We performed a retrospective study to evaluate patterns of use, efficacy and safety for axi-cel and tisa-cel. Data from 70 patients who underwent apheresis for commercial CAR T cells between January 2018 and November 2019 in our institution were retrospectively collected. Sixty-one patients were infused. The median age at infusion was 59 years old (range 27-75 years). The median number of prior therapies was 3 (range, 2-6). The overall response rates (ORRs) at 1 month and 3 months were 63% and 45%, respectively, with 48% and 39% achieving a complete response (CR), respectively. After a median follow-up after infusion of 5.7 months, the median progression-free survival (PFS) was 3.0 months (95% CI, 2.8-8.8 months), and the median overall survival (OS) was 11.8 months (95% CI, 6.0-12.6 months). In multivariate analysis, factors associated with poor PFS were the number of previous lines of treatment before CAR T cells (≥4) (P = .010) and a C reactive protein (CRP) value >30 mg/L at the time of lymphodepletion (P < .001). Likewise, the only factor associated with a shorter OS was CRP >30 mg/L (P = .009). Cytokine release syndrome (CRS) of any grade occurred in 85% of patients, including 8% of patients with CRS of grade 3 or higher. Immune cell-associated neurotoxicity syndrome (ICANS) of any grade occurred in 28% of patients, including 10% of patients with ICANS of grade 3 or higher. Regarding efficacy and safety, no significant difference was found between axi-cel and tisa-cel. This analysis describes one of the largest real-life cohorts of patients treated with axi-cel and tisa-cel for R/R aggressive B cell lymphoma in Europe.
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