Comparative inpatient outcomes among FDA-approved chimeric antigen receptor T-cell products: An analysis of the 2023 National Inpatient Sample.

Abstract

e23088 Background: Chimeric antigen receptor T-cell (CAR-T) therapy has transformed the treatment landscape for relapsed or refractory hematologic malignancies. National data comparing inpatient outcomes among different CAR-T products is limited. The CMS introduced ICD10-PCS procedure codes for individual CAR-T products that went into effect on October 1st, 2021. Leveraging these codes, we conducted a national analysis of real-world inpatient outcomes associated with FDA-approved CAR-T therapies in 2023. Methods: We conducted a retrospective cross-sectional study using the 2023 Healthcare Cost and Utilization Project National Inpatient Sample. Hospitalizations involving CAR-T therapy were identified using ICD-10-PCS procedure codes. The primary outcome was a composite measure of severe inpatient toxicity, defined as the occurrence of any of the following: in-hospital mortality, mechanical ventilation, clinically significant cytokine release syndrome (CRS), or clinically significant immune effector cell-associated neurotoxicity syndrome (ICANS). Secondary outcomes included individual components of the composite, and tumor lysis syndrome (TLS). National estimates were generated using discharge-level survey weights. Pairwise comparisons were performed using the Rao-Scott chi-square test with Bonferroni correction for multiple comparisons. Statistical analysis was conducted using the SAS software (SAS Institute, Cary, NC). Results: A total of 1,117 (weighted N = 5,585) inpatient CAR-T hospitalizations occurred nationally in 2023. The mean age was 61 years with 62% being male. Underlying indications included Large B-Cell Lymphoma (40%), Multiple Myeloma (28.9%), Acute Lymphoblastic Leukemia (7.3%) and other hematologic malignancies. The composite severe toxicity outcome occurred in 27.8% of hospitalizations. Clinically significant CRS and clinically significant ICANS occurred in 18.1% and 14.8%, respectively, while 2.1% required mechanical ventilation and TLS occurred in 1.6% of hospitalizations. The in-hospital mortality rate was 1.9%. Compared with Axi-cel, Cilta-cel (aOR 0.51), Ide-cel (aOR 0.50), and Liso-cel (aOR 0.59) were associated with significantly lower odds of the composite outcome (p < 0.01). Compared with Axi-cel, Cilta-cel (aOR 0.15), Ide-cel (aOR 0.30), and Liso-cel (aOR 0.33) were associated with significantly lower odds of ICANS (p < 0.01). Conclusions: In this national analysis of CAR-T hospitalizations, substantial heterogeneity in severe toxicity and neurotoxicity was observed across FDA-approved CAR-T products. Compared with Axi-cel, several newer CAR-T therapies were associated with significantly lower odds of severe toxicity and neurotoxicity in real-world practice, highlighting important product-specific differences that may inform risk stratification and clinical decision making.