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Severe cytopenia after CD19 CAR T-cell therapy: a retrospective study from the EBMT Transplant Complications Working Party
Penack, O. Peczynski, C. Koenecke, C. Polge, E. Kuhnl, A. Fegueux, N. Daskalakis, M. Kröger, N. Dreger, P. Besley, C.
Penack, O.
Peczynski, C.
Koenecke, C.
Polge, E.
Kuhnl, A.
Fegueux, N.
Daskalakis, M.
Kröger, N.
Dreger, P.
Besley, C.
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Abstract
We investigated the incidence and outcome of anti-CD19 chimeric antigen receptor (CAR) T-cells-associated Common Terminology Criteria for Adverse Events (CTCAE) ≥grade 3 cytopenia. In the EBMT CAR-T registry, we identified 398 adult patients with large B-cell lymphoma who had been treated with CAR-T-cells with axicel (62%) or tisacel (38%) before August 2021 and had cytopenia status documented for the first 100 days. Most patients had received two or three previous lines of therapy, however, 22.3% had received four or more. Disease status was progressive in 80.4%, stable in 5.0% and partial/complete remission in 14.6%. 25.9% of the patients had received a transplantation before. Median age was 61.4 years (min-max; IQR=18.7-81; (52.9-69.5)).The cumulative incidence of ≥grade 3 cytopenia was 9.0% at 30 days (95% CI (6.5 to 12.1)) and 12.1% at 100 days after CAR T-cell infusion (95% CI (9.1 to 15.5)). The median time from CAR-T infusion to cytopenia onset was 16.5 days (min-max; IQR=1-90; (4-29.8)). Grade 3 and grade 4 CTCAE cytopenia occurred in 15.2% and 84.8%, respectively. In 47.6% there was no resolution.Severe cytopenia had no significant impact on overall survival (OS) (HR 1.13 (95% CI 0.74 to 1.73), p=0.57). However, patients with severe cytopenia had a poorer progression-free survival (PFS) (HR 1.54 (95% CI 1.07 to 2.22), p=0.02) and a higher relapse incidence (HR 1.52 (95% CI 1.04 to 2.23), p=0.03). In those patients who developed severe cytopenia during the first 100 days (n=47), OS, PFS, relapse incidence and non-relapse mortality at 12 months after diagnosis of severe cytopenia were 53.6% (95% CI (40.3 to 71.2)), 20% (95% CI (10.4 to 38.6)), 73.5% (95% CI (55.2 to 85.2)) and 6.5% (95% CI (1.7 to 16.2)), respectively.In multivariate analysis of severe cytopenia risk factors, only year of CAR-T infusion (HR=0.61, 95% CI (0.39 to 0.95), p=0.028) and total number of treatment lines before CAR-T infusion (one or two lines vs three or more, HR=0.41, 95% CI (0.21 to 0.83), p=0.013) had a significant positive association with the incidence of cytopenia. Other factors, such as previous transplantation, disease status at time of CAR-T, patient age and patient sex, had no significant association.Our data provide insight on frequency and clinical relevance of severe cytopenia after CAR T-cell therapy in the European real-world setting.
Authors
Penack, O.
Peczynski, C.
Koenecke, C.
Polge, E.
Kuhnl, A.
Fegueux, N.
Daskalakis, M.
Kröger, N.
Dreger, P.
Besley, C.
Schanz, U.
Bloor, Adrian
Ganser, A.
Forcade, E.
Corral, L. L.
Passweg, J. R.
Novak, U.
Moiseev, I.
Schoemans, H.
Basak, G. W.
Chabannon, C.
Sureda, A.
Averbuch, D.
Glass, B.
de la Camara, R.
Peric, Z.
Peczynski, C.
Koenecke, C.
Polge, E.
Kuhnl, A.
Fegueux, N.
Daskalakis, M.
Kröger, N.
Dreger, P.
Besley, C.
Schanz, U.
Bloor, Adrian
Ganser, A.
Forcade, E.
Corral, L. L.
Passweg, J. R.
Novak, U.
Moiseev, I.
Schoemans, H.
Basak, G. W.
Chabannon, C.
Sureda, A.
Averbuch, D.
Glass, B.
de la Camara, R.
Peric, Z.
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Date
2023
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Article
Citation
Penack O, Peczynski C, Koenecke C, Polge E, Kuhnl A, Fegueux N, et al. Severe cytopenia after CD19 CAR T-cell therapy: a retrospective study from the EBMT Transplant Complications Working Party. Journal for immunotherapy of cancer. 2023 Apr;11(4). PubMed PMID: 37072350. Pubmed Central PMCID: PMC10124318. Epub 2023/04/19. eng.