Chimeric Antigen Receptor T Cell Therapy Management and Safety: A Practical Tool From a Multidisciplinary Team Perspective

Abstract

PurposeThe use process for chimeric antigen receptor T (CAR-T) cell drugs is complex and has been associated with a number of potentially severe complications, which requires management by a multidisciplinary team. Pharmacists are a key element in the team and have roles and responsibilities. Our objective was to develop a structured and practical guide that supports hospital pharmacist responsibilities and defines specific activities in a CAR-T cell therapy program, specifically in Europe.MethodsA literature review was performed, and the recommendations related to pharmacy practice in CAR-T therapy programs were analyzed. A multidisciplinary team was assembled, and meetings were held to address the key tasks in the CAR-T cells’ management process and to create the guide, based on national and international recommendations and in expert’s opinions.ResultsThe multidisciplinary team defined the following key tasks and issued recommendations to improve patient safety, treatment efficacy, and quality: patient selection and evaluation, CAR-T cell drug order to manufacturer, apheresis and material shipment, reception of CAR-T cell drug and storing, CAR-T cell drug prescription and pharmacy verification, CAR-T cell drug thawing and dispensing, CAR-T cell drug administration, patient education, pharmacovigilance and monitoring and outcomes’ record and evaluation. In each task the pharmacist’s role and how it can improve patient care are defined. A checklist was created to guarantee the compliance of standard operating procedures approved in the institution to manage CAR-T cell therapy and as a tool to collect required data for outcomes’ record and evaluation.ConclusionThis article provides a consensus set of safety recommendations regarding CAR-T therapy management in clinical practice, easily implementable by other institutions in the European setting. The guide identifies key steps where the involvement of hospital pharmacists would improve the safety and quality of the process and is a support guide to standardize hospital pharmacists’ responsibilities within the multidisciplinary team.

Interleukin Inhibitors in Cytokine Release Syndrome and Neurotoxicity Secondary to CAR-T Therapy

“…CAR-T therapy is an innovative and effective therapeutic option for the treatment of hematological malignancies refractory to previous treatment lines or multiple relapses [1][2][3][4][5][6][7][8][9][10]12,[16][17][18][19][20][21][22][23][24][25][26][27][28][29][30]32,34,[37][38][39][40][41][42][43][44][45][46].…”

“…As it is an immunological therapy, when the antigen receptors are introduced into the body, T lymphocytes trigger an immune response that attacks the tumor but can also attack healthy cells. The two most frequent adverse effects of the infusion of CAR-T cells are neurotoxicity syndrome associated with immune effector cells (ICANS) and cytokine release syndrome (CRS) [ 1 , 14 , 17 , 18 , 19 ].…”

Pharmacist-Urologist Collaborative Management Improves Clinical Outcomes in Patients With Castration-Resistant Prostate Cancer Receiving Enzalutamide

“…The value of pharmacist-led team care in pharmacotherapies has been demonstrated in numerous studies ( Yamamoto et al, 2018 ; Escudero-Vilaplana et al, 2020 ; Satsuma et al, 2020 ; Ji et al, 2021 ; Jia et al, 2021 ; Marzal-Alfaro et al, 2021 ; Miura et al, 2021 ; Xu et al, 2021 ). The results of this study revealed that pharmacist-urologist collaborative management can also improve care for patients with CRPC receiving enzalutamide in an ambulatory care setting.…”

The Past, Present, and Future of Clinically Applied Chimeric Antigen Receptor-T-Cell Therapy

“…Moreover, cooperation should be secured with departments other than those of the specialists, such as the intensive care unit (ICU) and the neurology department, before the operation [19]. In addition, the involvement of administrative departments, such as legal affairs and finance, are also necessary for the hospital to establish new treatment modalities [21]. When patients receive CAR-T-cell therapy, numerous personnel are involved in the many treatment steps mentioned above [22,23].…”