Risk of gastrointestinal adverse events associated with chimeric antigen receptor T-cell therapy (CAR-T): A nationwide analysis.

Abstract

e19505 Background: Chimeric antigen receptor T-cell therapy (CAR-T) has been successfully used and has improved outcomes in the treatment of B-cell hematological malignancies and multiple myeloma. There is evidence that unique serious adverse events like cytokine release syndrome (CRS) and Immune effector cell associated neurotoxicity syndrome (ICANS) are associated with CAR-T. Gastrointestinal adverse events (GI-AE) are commonly observed after CAR-T, although they are not well characterized. In the analysis, we summarized the incidence of gastrointestinal adverse events (GI-AE) and mortality associated with CAR-T with or without CRS. Methods: We conducted a retrospective cohort study using the 2020 Nationwide Inpatient Sample database, which is the largest nationally representative inpatient database in the United States. The dataset is weighted to obtain national estimates, and ICD-10 was utilized to identify admissions for CAR-T. The primary outcome is in-hospital mortality, and secondary outcomes are GI-AE associated with CAR-T with or without CRS and length of stay (LOS). Odds ratio (OR) and Mean difference (MD) were adjusted for confounders like comorbidities and sociodemographics using multivariate regression analysis. Results: There were 32 million weighted discharges in the 2020 NIS database; a total of 1950 cases were identified receiving CAR-T therapy with a mean age of 56.53, male 60.51%, and white race 74.8%. In our study, 40.25% had GI-AE, 15.38% had CRS and 13.8% had ICANS. The most common GI-AE was nausea and vomiting (23.84%). Other GI-AE were diarrhea (9.5%), colitis (8.2%), peptic ulcer disease (2.9%), hepatic failure (1.28%), and pancreatitis (2.2%). 68 (3.85%) patients died after receiving CAR-T. The results revealed that CAR-T with GI-AE was not significantly associated with in-hospital mortality (adjusted OR = 1.12, 95% CI: 0.29-4.24), and LOS (adjusted mean difference = 3.38, 95% CI: -0.91-7.67) compared to CAR-T without GI-AE. Liver failure is significantly associated with the highest mortality after CAR-T (OR = 46.62, 95% CI: 6.9-315). Conclusions: The national survey reveals that predominantly GI-AE are mild including nausea, vomiting, and diarrhea. GI-AE related with CAR-T had similar outcomes including mortality and LOS compared to CAR-T without GI-AE. The risk of mortality becomes higher when CAR-T complicated by hepatic failure. [Table: see text]