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Optimizing the post-CAR T monitoring period in recipients of axicabtagene ciloleucel, tisagenlecleucel, and lisocabtagene maraleucel

Nausheen Ahmed, William Wesson, Forat Lutfi, David L. Porter and 12 more

Blood Advances | Jul 23, 2024 | 27 citations

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What this paper is about

New-onset CRS and ICANS are rare after 2 weeks for axi-cel, tisa-cel, and liso-cel, making flexible monitoring beyond 14 days seem safe, making flexible monitoring beyond 14 days seem safe.

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CD19-directed chimeric antigen receptor T-cell (CAR T) therapies, including axicabtagene ciloleucel (axi-cel), tisagenlecleucel (tisa-cel), and lisocabtagene maraleucel (liso-cel), have transformed the treatment landscape for B-cell non-Hodgkin lymphoma, showcasing significant efficacy but also highlighting toxicity risks such as cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS). The US Food and Drug Administration has mandated patients remain close to the treatment center for 4 weeks as part of a Risk Evaluation and Mitigation Strategy to monitor and manage these toxicities, which, although cautious, may add to cost of care, be burdensome for patients and their families, and present challenges related to patient access and socioeconomic disparities. This retrospective study across 9 centers involving 475 patients infused with axi-cel, tisa-cel, and liso-cel from 2018 to 2023 aimed to assess CRS and ICANS onset and duration, as well as causes of nonrelapse mortality (NRM) in real-world CAR T recipients. Although differences were noted in the incidence and duration of CRS and ICANS between CAR T products, new-onset CRS and ICANS are exceedingly rare after 2 weeks after infusion (0% and 0.7% of patients, respectively). No new cases of CRS occurred after 2 weeks and a single case of new-onset ICANS occurred in the third week after infusion. NRM is driven by ICANS in the early follow-up period (1.1% until day 28) and then by infection through 3 months after infusion (1.2%). This study provides valuable insights into optimizing CAR T therapy monitoring, and our findings may provide a framework to reduce physical and financial constraints for patients.

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Authors

Researchers on this paper

Nausheen Ahmed

first | The University of Kansas Cancer Center | ORCID 0000-0003-4336-4982

William Wesson

middle | The University of Kansas Cancer Center | ORCID 0000-0002-9534-0512

Forat Lutfi

middle | The University of Kansas Cancer Center | ORCID 0000-0002-9699-3080

David L. Porter

middle | University of Pennsylvania | ORCID 0000-0001-6333-9536

Veronika Bachanová

middle | University of Minnesota | ORCID 0000-0002-9325-432X

Loretta J. Nastoupil

middle | The University of Texas MD Anderson Cancer Center | ORCID 0000-0001-6071-8610

Miguel‐Angel Perales

middle | Memorial Sloan Kettering Cancer Center | ORCID 0000-0002-5910-4571

Richard T. Maziarz

middle | OHSU Knight Cancer Institute | ORCID 0000-0002-8184-7099

Jamie Brower

middle | University of Pennsylvania | ORCID 0000-0003-1614-8934

Gunjan L. Shah

middle | Memorial Sloan Kettering Cancer Center | ORCID 0000-0002-9977-0456

Andy I. Chen

middle | Oregon Health & Science University

Olalekan O. Oluwole

middle | Vanderbilt University Medical Center | ORCID 0000-0001-8525-9641

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Citation

BibTeX

@article{Ahmed2024Optimizing,
  title = {Optimizing the post-CAR T monitoring period in recipients of axicabtagene ciloleucel, tisagenlecleucel, and lisocabtagene maraleucel},
  author = {Nausheen Ahmed and William Wesson and Forat Lutfi and David L. Porter and Veronika Bachanová and Loretta J. Nastoupil and Miguel‐Angel Perales and Richard T. Maziarz and Jamie Brower and Gunjan L. Shah and Andy I. Chen and Olalekan O. Oluwole and Stephen J. Schuster and Michael Bishop and Joseph P. McGuirk and Peter A. Riedell},
  journal = {Blood Advances},
  year = {2024},
  doi = {10.1182/bloodadvances.2023012549},
  url = {https://doi.org/10.1182/bloodadvances.2023012549}
}

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