Safety of Axicabtagene Ciloleucel for the Treatment of Relapsed or Refractory Large B-Cell Lymphoma. Clin Lymphoma Myeloma Leuk 2021 Apr;21(4):238-245
Date
11/03/2020Pubmed ID
33132101DOI
10.1016/j.clml.2020.10.005Scopus ID
2-s2.0-85094605341 (requires institutional sign-in at Scopus site) 8 CitationsAbstract
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.
Author List
Grana A, Gut N, Williams K, Maakaron J, Porter K, William BM, Vasu S, Penza S, Brammer JE, Saad A, Puto M, Jaglowski SM, Roddy JAuthor
Samantha M. Jaglowski MD, MPH Professor in the Medicine department at Medical College of WisconsinMESH terms used to index this publication - Major topics in bold
AdultAged
Anemia
Antineoplastic Agents, Immunological
Biological Products
Female
Health Status
Humans
Immunotherapy, Adoptive
Lymphoma, Large B-Cell, Diffuse
Male
Middle Aged
Neoplasm Recurrence, Local
Nervous System Diseases
Retreatment
Retrospective Studies
Survival Rate
Thrombocytopenia
Treatment Outcome
Young Adult