Chimeric Antigen Receptor T-cell Therapy: A Comprehensive Review of Clinical Efficacy, Toxicity, and Best Practices for Outpatient Administration

ABSTRACT Chimeric antigen receptor T-cell (CAR-T) therapy has been integrated into treatment algorithms for acute leukemia and lymphoma, and the number of clinical trials in both hematologic and solid tumor malignancies for new products and potential indications continues to grow. The clinical toxicities of CAR-T therapy include cytokine release syndrome and immune effector cell–associated neurotoxicity syndrome, which often warrant inpatient admission for close monitoring and treatment. Consequently, many centers have built processes around these cells being administered in the inpatient setting. As new products gain approval from the Food and Drug Administration with more manageable toxicity profiles and as institutions gain experience with the management of these toxicities, outpatient administration and monitoring should be expected. Additionally, payer reimbursements for inpatient treatment have left the sustainability of inpatient CAR-T therapy in jeopardy, especially for centers whose payer mix includes a high proportion of Medicare patients. This has the serious potential to limit access to care. As use of CAR-T therapy continues to expand, changes in either payment models, care settings, or both are necessary to ensure the sustainability of safe, efficient, and cost-effective treatment. This review outlines the efficacy and toxicity of currently approved products, as well as best practices to optimize the management of CAR-T therapy in the outpatient setting.