Real-world outcomes of CAR-T in the outpatient setting.

Abstract

e19015 Background: Chimeric antigen receptor T (CAR-T) cell therapy has changed the treatment paradigm of relapsed/refractory (R/R) B cell malignancies and Multiple Myeloma (MM). Although most CAR-T clinical trials were conducted in the inpatient setting, there is a growing interest in investigating the safety and feasibility of outpatient administration of CAR-T therapy in the ambulatory settings. Methods: After obtaining institutional IRB approval, we performed a retrospective analysis of all adult patients with hematologic malignancies who received CAR-T therapy at the University of Oklahoma Medical Center from September 2019 through July 2024. Patients with solid tumors and those who received investigational (non-FDA approved) CAR-T cell products were excluded from this analysis. Descriptive statistics were created for all variables. Kaplan-Meier methods and log-rank tests were compared for overall survival (OS). Cox Proportional Hazards Regression was used to explore both adjusted and unadjusted OS. SAS 9.4 was used to perform all analysis. An alpha of 0.05 was used to determine significance. Results: A total of 107 patients were identified (median age = 60 years, 43.0% female, 74.8% White, 95.0% ECOG < 2, %50.5% BMI 25 or higher, Median number of prior lines was 3 and 23.3% had history of prior transplant) with the following cancers, Large B cell Lymphoma (48.6%), Multiple myeloma (26.2%), B-ALL (14%), Follicular lymphoma (8.4%) and Mantle cell lymphoma (2.8%). The most commonly used products were axicabtagene ciloleucel (43.0%), idecabtagene vicleucel (15%), and brexucabtagene autoleucel (11.2%). Any-grade Cytokine release syndrome (CRS) was reported in 66.4% of patients for which Tocilizumab was administered in 92.7%. Any-grade neurotoxicity was reported in 27.7% of which steroids with/without Anakinra was administered in 95.8% . Grade 3-4 CRS was observed in 3 patients while grade 3-4 ICANS was reported in 8 patients. Infections within 100 days was reported in (n = 24) 25.5% of patients. 68% were alive at the time of this analysis. The median OS was 32.3 months (95% CI 24.1 – No Estimate) with the median follow up time of 11 months. LDH and hemoglobin were associated with OS (HR = 1.02; 95% 1.0 – 1.03; p = 0.0102) and (HR = 0.26; 95% 0.12 – 0.54; p = 0.0003) respectively after adjustment and similar findings were noted for adjusted 6 Month mortality (HR = 1.01; 95% 1.0 – 1.01; p = 0.0279) and (HR = 0.57; 95% 0.36 – 0.91; p = 0.0191). Conclusions: Our experience revealed that treatment with CAR-T in the outpatient setting is safe and feasible with adequate institutional experience. Proper toxicity monitoring and management could help optimize healthcare utilization, and CAR-T accessibility.