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5PSQ-059 Immune effector cell-associated neurotoxicity syndrome in CAR-T therapy: incidence, features, and outcomes in a tertiary hospital

ejhpharm · 2026-03-18 · canonical JSON source

30 visible annotations · policy: published · automated confidence ≥ 75.00%

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Background and Importance Chimeric Antigen Receptor T-cell (CAR-T) therapy has improved outcomes in relapsed or refractory haematological malignancies. Nevertheless, immune effector cell-associated neurotoxicity syndrome (ICANS) is a relevant complication, frequently associated with cytokine release syndrome (CRS), and may lead to intensive care unit (ICU) admission or death.Aim and Objectives To describe the incidence, characteristics, and outcomes of ICANS in patients treated with CAR-T therapy, focusing on the most prevalent diagnoses and products.Material and Methods Observational, retrospective study including all patients receiving CAR-T therapy between January 2020 and April 2025. Data were collected from electronic health records (OrionClinic). Variables: demographics, diagnosis, CAR-T product, hospital stay, CRS, ICANS (incidence, duration, relapses, treatment and response, CRS concomitance), ICU admission and ICANS-related mortality. Continuous variables were expressed as median (interquartile range, IQR), and categorical variables as absolute and relative frequencies. Statistical analysis was performed with R v.4.4.3Results Seventy patients were included, median age 61 years (52–68), 54% men. Main diagnoses: diffuse large B-cell lymphoma (DLBCL, n = 53, 76%), acute lymphoblastic leukaemia (ALL, n = 6, 9%), and multiple myeloma (MM, n = 6, 9%). CAR-T products: axicabtagene ciloleucel (n = 37, 53%), tisagenlecleucel (n = 20, 29%) and ciltacabtagene autoleucel (n = 5, 7%), other academic or commercialised products (11%).ICANS occurred in 26 patients (37%), developing at 6.5 days (4.25–8.0) post-infusion, lasting 2 days (1–3). Grades: 10 patients (38.5%) grade 1, 3 (11.5%) grade 2, 9 (34.6%) grade 3, and 4 (15.4%) grade 4; 50% were severe (grade 3–4). CRS occurred in 60 (86%), concomitant with ICANS in 10 (14%). Relapses occurred in 9 (13%). Corticosteroids were the main treatment; anakinra was reserved for refractory cases. ICU admission due to ICANS was required in 20 (29%). Mortality directly related to ICANS was 1 case.By product, ICANS incidence was: axicabtagene ciloleucel 23/37 (62%) vs tisagenlecleucel 0%. By main diagnosis: DLBCL 23/53 (43%), ALL 1/6 (17%) and MM 0%.Conclusion and Relevance ICANS occurred in over one-third of patients, especially in DLBCL treated with axicabtagene ciloleucel, while none were reported with tisagenlecleucel. Despite low mortality, relapses increased clinical complexity and ICU requirements. Continuous monitoring and early management are essential to optimise outcomes.Conflict of Interest No conflict of interest