Safety and efficacy of outpatient CAR-T therapy in a community-based medical center.

Abstract

e19091 Background: Chimeric antigen receptor T-cell (CAR-T) therapies have transformed treatment landscape for hematologic malignancies since FDA approval in 2017. Managing cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) are essential for safe and effective infusions in the outpatient setting. To date, the majority of CAR-T therapy has historically been delivered in major academic medical centers, preventing 41% or more of patients from receiving this potential lifesaving treatment. This retrospective analysis examines patients receiving CAR-T in an outpatient setting in a community hospital from 2019-2023. Patients were seen daily, admitted only with complications. An efficacy based comparative analysis of the clinical course, treatment-related toxicities, overall survival (OS), and progression-free survival (PFS) across Axicabtagene ciloleucel (Axi-cel) versus Lisocabtagene Maraleucel (Liso-cel) and Tisagenlecleucel (Tisa-cel) is referenced in the table below. Methods: The study consisted of 44 patients consecutive patients. This included 7 patients with follicular lymphoma, 36 patients with diffuse large B-cell lymphoma, and 1 patient with marginal cell lymphoma. 22 patients received treatment with Axi-cel, 6 patients were treated with Liso-cel, and 16 patients received Tisa-cel. 1 Axi-cel patient received prophylactic dexamethasone. Results: We used Axi-cel, which uses the CD28 co-stimulatory domain, compared to Liso-cel and Tisa-cel, which uses 4-1BB. The Axi-cel patients were younger, otherwise matched for bulk of disease and disease status and did not show a significant increase in toxicity compared to the Liso-cel and Tisa-cel patients. The PFS for the two groups were similar. Conclusions: This retrospective analysis confirms that outpatient CAR-T therapy can safely be administered in an outpatient community setting anticipated survival. This may allow more patients who cannot travel to receive this treatment. Comparative outcomes between CAR-T therapies. Axi-Cel (n=22) Liso-cel and Tisa-cel (n= 22) Median Age (years) 58.5 71.4 CRS All Grades n (%) 17 (77) 15 (68) CRS Grade 3/4 n (%) 0 (0) 1 (5) Neurotoxicity All Grades n (%) 13 (59) 9 (41) Neurotoxicity Grade 3/4 n (%) 1 (4.5) 3 (14) LDH >300 units/L prior to treatment n(mean) 5 (586) 8 (520) Progression-Free Survival Mean (months) 32.6 28.2 Overall Survival Mean (months) 52 51