PDF(Pubmed)
Abstract：
UNASSIGNED: Chimeric antigen receptor (CAR) T-cell therapy (CAR T therapy) is a treatment option for patients with relapsed or refractory multiple myeloma that has led to unprecedented treatment outcomes. Among CAR T therapies available, ciltacabtagene autoleucel (cilta-cel) is a good candidate for outpatient administration due to its generally predictable safety profile. There are multiple advantages of outpatient administration of cilta-cel, including reduced healthcare burden, expanded access, and patient autonomy. This mixed methods qualitative study aimed to identify key factors for outpatient administration of CAR T and best practice recommendations by combining a targeted literature review with expert interviews and panels.
UNASSIGNED: The targeted review (Phase 1) aimed to identify factors for outpatient CAR T administration in the US and determine key topics for the exploratory interviews (Phase 2) and expert panels (Phase 3), which aimed to inform on best practices and challenges of outpatient CAR T administration (focusing on cilta-cel). Participants in clinical and administrative positions based in treatment centers that had experience with real-world outpatient administration of cilta-cel were recruited.
UNASSIGNED: Seventeen studies were identified in Phase 1. Key factors for outpatient administration included the development of protocols for CAR T complications, education for caregivers, outpatient specialists, hospital staff, and emergency services staff for identification and referral after possible adverse events, the creation of multidisciplinary teams for effective communication and management, straightforward patient intake processes encompassing financial eligibility review and provision of patient education materials, and close patient monitoring throughout the treatment journey. In Phase 2, 5 participants from 2 centers were interviewed. In Phase 3, 14 participants across 6 treatment centers were interviewed. Two 90-minute virtual panel discussions took place. All participants agreed that cilta-cel can be safely and effectively administered in an outpatient setting. Key recommendations included the creation of educational resources for patients and caregivers, the development of standard operating procedures, dedicated outpatient infrastructure and establishment of interdisciplinary teams, outpatient monitoring for toxicity management, and monitoring of the reimbursement landscape.
UNASSIGNED: This study offers a comprehensive understanding of the feasibility of outpatient cilta-cel administration in participating CAR T centers and provides actionable recommendations while acknowledging existing challenges.
UNASSIGNED: The targeted review (Phase 1) aimed to identify factors for outpatient CAR T administration in the US and determine key topics for the exploratory interviews (Phase 2) and expert panels (Phase 3), which aimed to inform on best practices and challenges of outpatient CAR T administration (focusing on cilta-cel). Participants in clinical and administrative positions based in treatment centers that had experience with real-world outpatient administration of cilta-cel were recruited.
UNASSIGNED: Seventeen studies were identified in Phase 1. Key factors for outpatient administration included the development of protocols for CAR T complications, education for caregivers, outpatient specialists, hospital staff, and emergency services staff for identification and referral after possible adverse events, the creation of multidisciplinary teams for effective communication and management, straightforward patient intake processes encompassing financial eligibility review and provision of patient education materials, and close patient monitoring throughout the treatment journey. In Phase 2, 5 participants from 2 centers were interviewed. In Phase 3, 14 participants across 6 treatment centers were interviewed. Two 90-minute virtual panel discussions took place. All participants agreed that cilta-cel can be safely and effectively administered in an outpatient setting. Key recommendations included the creation of educational resources for patients and caregivers, the development of standard operating procedures, dedicated outpatient infrastructure and establishment of interdisciplinary teams, outpatient monitoring for toxicity management, and monitoring of the reimbursement landscape.
UNASSIGNED: This study offers a comprehensive understanding of the feasibility of outpatient cilta-cel administration in participating CAR T centers and provides actionable recommendations while acknowledging existing challenges.
摘要：
■嵌合抗原受体（CAR）T细胞疗法（CART疗法）是复发性或难治性多发性骨髓瘤患者的治疗选择，已导致前所未有的治疗结果。在可用的CART疗法中，ciltacabtageneautoleucel（cilta-cel）由于其通常可预测的安全性而成为门诊用药的良好候选者。cilta-cel的门诊管理有多种优势，包括减轻医疗负担，扩展访问，患者自主性这项混合方法的定性研究旨在通过将有针对性的文献综述与专家访谈和小组相结合，确定CART门诊管理的关键因素和最佳实践建议。
■目标审查（第1阶段）旨在确定美国门诊CART管理的因素，并确定探索性访谈（第2阶段）和专家小组（第3阶段）的关键主题。旨在告知门诊CART管理的最佳实践和挑战（重点是cilta-cel）。招募了在治疗中心担任临床和行政职务的参与者，这些参与者具有实际门诊cilta-cel的经验。
■在第一阶段确定了17项研究。门诊管理的关键因素包括制定CART并发症的方案，对护理人员的教育，门诊专家，医院工作人员,和紧急服务人员在可能的不良事件发生后进行识别和转诊，建立多学科团队进行有效的沟通和管理，包括财务资格审查和提供患者教育材料的直接患者摄入过程，并在整个治疗过程中密切患者监测。在第二阶段，来自2个中心的5名参与者接受了采访。在第3阶段，采访了6个治疗中心的14名参与者。进行了两次90分钟的虚拟小组讨论。所有参与者都同意cilta-cel可以在门诊环境中安全有效地管理。主要建议包括为患者和护理人员创建教育资源，制定标准操作程序，专门的门诊基础设施和跨学科团队的建立，门诊毒性管理监测，以及对报销情况的监测。
■本研究全面了解参与CART中心的门诊cilta-cel管理的可行性，并在承认现有挑战的同时提供可操作的建议。
■目标审查（第1阶段）旨在确定美国门诊CART管理的因素，并确定探索性访谈（第2阶段）和专家小组（第3阶段）的关键主题。旨在告知门诊CART管理的最佳实践和挑战（重点是cilta-cel）。招募了在治疗中心担任临床和行政职务的参与者，这些参与者具有实际门诊cilta-cel的经验。
■在第一阶段确定了17项研究。门诊管理的关键因素包括制定CART并发症的方案，对护理人员的教育，门诊专家，医院工作人员,和紧急服务人员在可能的不良事件发生后进行识别和转诊，建立多学科团队进行有效的沟通和管理，包括财务资格审查和提供患者教育材料的直接患者摄入过程，并在整个治疗过程中密切患者监测。在第二阶段，来自2个中心的5名参与者接受了采访。在第3阶段，采访了6个治疗中心的14名参与者。进行了两次90分钟的虚拟小组讨论。所有参与者都同意cilta-cel可以在门诊环境中安全有效地管理。主要建议包括为患者和护理人员创建教育资源，制定标准操作程序，专门的门诊基础设施和跨学科团队的建立，门诊毒性管理监测，以及对报销情况的监测。
■本研究全面了解参与CART中心的门诊cilta-cel管理的可行性，并在承认现有挑战的同时提供可操作的建议。
