Safety of Axicabtagene Ciloleucel for the Treatment of Relapsed or Refractory Large B-Cell Lymphoma

Allison Grana, Natalia Gut, Kiersten Williams, Joseph Maakaron, Kyle Porter, Basem M. William, Sumithira Vasu, Sam Penza, Jonathan E. Brammer, Ayman Saad, Marcin Puto, Samantha M. Jaglowski, Julianna Roddy

Research output: Contribution to journalArticlepeer-review

Abstract

Background: Diffuse large B-cell lymphoma is the most common type of non-Hodgkin lymphoma. Recent advances in immunotherapy have resulted in the development of chimeric antigen receptor–modified T-cell (CAR-T) therapy, such as axicabtagene ciloleucel (axi-cel). However, axi-cel administration is not without risks of toxicity. Patients and Methods: This retrospective study of 37 patients with relapsed or refractory diffuse large B-cell lymphoma evaluated the incidence and severity of common and severe safety events after axi-cel treatment in a real-world setting. Ninety percent of patients had received 3 or more prior lines of therapy (median prior therapies 3, range 2-7) before receiving CAR-T therapy, and 32.4% had relapsed after prior stem-cell transplantation. Results: All but one patient experienced cytokine release syndrome (CRS) of any grade (97.3%). Of those 36 patients, 83.3% experienced maximum CRS grade of 1 or 2, occurring after a median of 27 hours and persisting for a median of 6 days. Twenty-seven patients (73.0%) experienced neurotoxicity of any grade. Of those 27 patients, 96.3% experienced maximum neurotoxicity grade of 2 or higher, occurring after a median of 145 hours (6 days) and persisting for a median of 7 days. All 10 patients aged 65 or older had neurotoxicity of grade 2 or higher, compared to 59.3% (11/27) under age 65 (P = .02). Patients with baseline Eastern Cooperative Oncology Group performance status score of 2 were significantly more likely to have shorter time to neurotoxicity compared to patients with performance status of 0 (P = .01). Conclusion: With more real-life experience and data, we will be able to define and refine management of toxicities unique to CAR-T therapy.

Original languageEnglish (US)
Pages (from-to)238-245
Number of pages8
JournalClinical Lymphoma, Myeloma and Leukemia
Volume21
Issue number4
DOIs
StatePublished - Apr 2021

Bibliographical note

Funding Information:
S.V. discloses consulting services with Omeros, Johnson and Johnson, and AlloVir as well as a licensing agreement with The Ohio State University and Kiadis Inc. S.M.J. discloses advisory board funding from Kite , Novartis , Juno , and CRISPR Therapeutics as well as research funding from Kite , Novartis , and Unum Therapeutics . The other authors have stated that they have no conflict of interest.

Funding Information:
S.V. discloses consulting services with Omeros, Johnson and Johnson, and AlloVir as well as a licensing agreement with The Ohio State University and Kiadis Inc. S.M.J. discloses advisory board funding from Kite, Novartis, Juno, and CRISPR Therapeutics as well as research funding from Kite, Novartis, and Unum Therapeutics. The other authors have stated that they have no conflict of interest.

Publisher Copyright:
© 2020 Elsevier Inc.

Keywords

  • Cellular therapy
  • Cytokine release syndrome
  • Neurotoxicity
  • Pharmacology
  • Toxicity management

PubMed: MeSH publication types

  • Journal Article

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