Chimeric antigen receptor T‐cell therapy: Challenges and framework of outpatient administration

Abstract

Adoptive cellular therapy has made a landmark change within the treatment paradigm of several hematologic malignancies, and novel cellular therapy products, such as chimeric antigen receptor T‐cell therapy (CART), have demonstrated impressive efficacy and produced durable responses. However, the CART treatment process is associated with significant toxicities, healthcare resource utilization, and financial burden. Most of these therapies have been administered in the inpatient setting due to their toxicity profile. Improved toxicity management strategies and a better understanding of cellular therapy processes are now established. Therefore, efforts to transition CART to the outpatient setting are warranted with the potential to translate into enhanced patient quality of life and cost savings. A successful launch of outpatient CART requires several components including a multidisciplinary cellular therapy team and an outpatient center with appropriate clinical space and personnel. Telemedicine should be incorporated for closer monitoring. Additionally, clear criteria for admission upon clinical decompensation, a pathway for prompt inpatient transition, and clear toxicity management guidelines should be implemented. Effective education about cellular therapy and toxicity management is imperative, especially for the Emergency Department and Intensive Care Unit teams. Here, we have outlined the various logistical and clinical considerations required for the care of CART patients, which will aid centers to establish an outpatient CART program.

Feasibility of outpatient administration of axicabtagene ciloleucel and brexucabtagene autoleucel using telemedicine tools: The Vanderbilt experience

“…9 During the development of our outpatient CAR-T programme, we established processes to ensure appropriate staffing in the clinic for the twice-daily visits, to educate patients and caregivers on performing vital sign evaluation and telemedicine visits, availability of designated beds in case of urgent admission, and ability to deliver tocilizumab in the outpatient setting. 11 Apart from the patient preference and improved quality of life, outpatient administration can also bring significant cost reduction to already expensive therapy. 12 Our results show that axi-cel and brexu-cel can be safely administered in the outpatient setting with appropriate monitoring and careful patient selection.…”

Clinician and administrator perspectives on outpatient administration of ciltacabtagene autoleucel in relapsed or refractory multiple myeloma

“…Two additional recommendations to establish a successful outpatient CAR T program identified in the review include the creation of multidisciplinary teams that can efficiently communicate with each other to manage patients throughout the outpatient journey ( 30 , 32 , 35 ), and the development of straightforward patient intake processes encompassing financial eligibility review and provision of patient education materials ( 28 ).…”

Development of a Core Set of Patient- and Caregiver-Reported Signs and Symptoms to Facilitate Early Recognition of Acute Chimeric Antigen Receptor T-Cell Therapy Toxicities

“…17,29,30 However, as indications expand, more CAR T-cell products with favorable toxicity profiles become available, numbers of treated patients increase and prediction of severe toxicity will be optimized; we anticipate that outpatient treatment will become the mainstay for CAR T-cell therapy. 31,32 Outpatient treatment in the clinical trial setting has already proven to be feasible. However, only highly preselected patients treated with CAR T-cell products with a favorable toxicity profile were recruited to these trials.…”