A national inpatient sample analysis for CAR-T cell therapy administration.

Abstract

e19501 Background: Chimeric antigen receptor T-cell therapies (CAR-T) improve relapse free survival and durable remission rates in patients with relapsed/refractory large B-cell lymphoma (LBCL) and received US FDA approval in 2017. The cytokine release syndrome (CRS) and immune-effector cell associated neurotoxicity (ICANS) due to CAR-T cell therapy require close inpatient monitoring. Real world data are lacking regarding the cost of hospitalization, length of stay (LOS), toxicity, and mortality associated with CAR-T. The goal of this study was to analyze the clinical outcomes of inpatient CAR-T utilizing a national database. Methods: Data was collected from the 2018 version of the Nationwide Inpatient Sample (NIS) database. Patients who received CAR-T were identified with ICD-10 disease and procedure codes . Complex weights were used to enable appropriate national projections. The association between toxicity (particularly related to CRS and ICANS) and outcomes was examined using logistic regression analyses (p < 0.05 statistically significant). SAS v9.4 (SAS Institute, Cary, NC) was used for data analysis. Results: 306 patients met selection criteria. Demographic criteria were as follows: 61.1% males, 62.4% white, median age 58.0 years old (IQR 45.2-65.0), and private insurance (56.9%). A majority received care at urban teaching (97.7%) and large hospitals (73.2%). Relevant complications during hospitalization included hypotension (24.5%), pneumonia (8.5%), sepsis (9.8%), seizure (5.9%), neutropenia (24.5%), thrombocytopenia (8.8%), tumor lysis syndrome (TLS) (3.3%), and acute kidney injury (AKI) (14.1%). Median LOS was 16 days (IQR 12.0-22.0), median charge for hospitalization was $493,887 USD (IQR 143,400.0-1,182,940.0), and inpatient mortality was 5.2%. On multivariate regression analysis, inpatient mortality was significantly higher in those with intubation (OR 30.1, 95%CI 3.45-262), sepsis (OR 9.49, 95%CI 1.48-60.7), TLS (OR 18.9, 95%CI 2.52-140), AKI (OR 24.7, 95% CI 1.37-447) and thrombocytopenia (OR 53.4, 95% CI 2.19-1,298). LOS was higher in those with blood transfusion (OR 1.29, 95% CI 1.08-1.53), sepsis (OR 2.04, 95% CI 1.59-2.61), pancreatitis (OR 2.03, 95% CI 1.09-3.77), pneumonia (OR 1.39, 95%CI 1.04-1.87) and treatment in urban teaching hospitals (OR 1.53, 95%CI 1.02-2.30). Increased hospitalization charges were associated with hypotension (OR 1.54, 95%CI 1.14-2.08) and with treatment at urban teaching hospitals (OR 7.46, 95%CI 4.67-11.9) and medium size hospitals (OR 1.49, 95%CI 1.04-2.15). Conclusions: Inpatient mortality, median LOS, and hospitalization charges in inpatients treated with CAR-T can be significantly increased not only by inpatient complications, but also by the size and type of the treating facility. These findings highlight the financial burden of CAR-T cell therapy in the real world and can be used to shape future healthcare policy.