作为标准治疗的门诊 CAR T 细胞疗法:当前的观点和考虑因素

Katie S. Gatwood, Zahra Mahmoudjafari, Brittney Baer, Stacy Pak, Hoim Kim, Karin Abernathy, B. Dholaria, Olalekan Oluwole
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摘要

嵌合抗原受体 T 细胞疗法(CAR-T)改变了多种血液恶性肿瘤的治疗格局。直到最近,由于 CAR-T 的毒性,大多数 CAR-T 输注都是在住院环境中进行的。然而,新产品结构的出现以及不良反应检测和管理的改进,大大提高了这些疗法的安全性。CAR-T 适应症在继续扩大,而住院治疗会增加医疗资源的利用率和总体成本。因此,将 CAR-T 治疗过渡到门诊环境,以改善就医条件、减轻经济负担并提高患者满意度,一直备受关注。建立一个成功的门诊 CAR-T 需要几个要素,包括一个多学科细胞治疗团队和一个拥有适当临床空间和人员的门诊中心。此外,还应制定明确的门诊管理资格标准和住院标准,并提供及时的毒性评估和入院途径以及毒性管理指南。必须对所有临床工作人员、患者及其护理人员进行 CAR-T 疗法及其相关毒性的教育。最后,严格的财务规划以及与支付方的紧密合作对项目的成功和可持续性至关重要,这样才能在有效管理成本的同时确保公平的治疗机会。本综述总结了目前已发表的经验以及专家对实施门诊 CAR-T 项目的看法。
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Outpatient CAR T-Cell Therapy as Standard of Care: Current Perspectives and Considerations
Chimeric antigen receptor T-cell therapy (CAR-T) has altered the treatment landscape of several hematologic malignancies. Until recently, most CAR-T infusions have been administered in the inpatient setting, due to their toxicity profile. However, the advent of new product constructs, as well as improved detection and management of adverse effects, have greatly increased the safety in administering these therapies. CAR-T indications continue to expand, and inpatient administration is associated with increased healthcare resource utilization and overall cost. Therefore, transitioning CAR-T administration to the outpatient setting has been of great interest in an effort to improve access, reduce financial burden, and improve patient satisfaction. Establishment of a successful outpatient CAR-T requires several components, including a multidisciplinary cellular therapy team and an outpatient center with appropriate clinical space and personnel. Additionally, clear criteria for outpatient administration eligibility and for inpatient admission with pathways for prompt toxicity evaluation and admission, and toxicity management guidelines should be implemented. Education about CAR-T therapy and its associated toxicities is imperative for all clinical staff, as well as patients and their caregivers. Finally, rigorous financial planning and close collaboration with payers to ensure equitable access, while effectively managing cost, are essential to program success and sustainability. This review provides a summary of currently published experiences, as well as expert opinion regarding implementation of an outpatient CAR-T program.
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