Department of Blood and Marrow Transplant and Cellular Immunotherapy, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, United States.
Blood and Marrow Transplant (BMT) and Cellular Therapy, Division of Hematology and Oncology, Medical College of Wisconsin, Milwaukee, WI, United States.
Front Immunol. 2024 Jun 10;15:1405452. doi: 10.3389/fimmu.2024.1405452. eCollection 2024.
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.
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.
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.
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.
嵌合抗原受体 (CAR) T 细胞疗法 (CAR T 疗法) 是治疗复发或难治性多发性骨髓瘤患者的一种选择，其治疗效果前所未有。在现有的 CAR T 疗法中，cilta-cel 由于其安全性可预测，是门诊管理的理想选择。cilta-cel 门诊管理有多个优势，包括减轻医疗负担、扩大治疗范围和提高患者自主性。本项混合方法定性研究旨在通过将靶向文献综述与专家访谈和小组讨论相结合，确定 CAR T 门诊管理的关键因素和最佳实践建议。
靶向综述（第 1 阶段）旨在确定美国 CAR T 门诊管理的因素，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，旨在提供有关 CAR T 门诊管理的最佳实践和挑战的信息（重点关注 cilta-cel）。研究招募了在具有 cilta-cel 真实世界门诊管理经验的治疗中心工作的临床和行政岗位的参与者。
第 1 阶段确定了 17 项研究。门诊管理的关键因素包括制定 CAR T 并发症的方案、对护理人员、门诊专家、医院工作人员和急救服务人员进行教育，以便在可能发生不良事件后进行识别和转介，建立多学科团队进行有效的沟通和管理、简化患者的准入流程，包括经济资格审查和提供患者教育材料，以及在整个治疗过程中密切监测患者。在第 2 阶段，有 2 个中心的 5 名参与者接受了访谈。在第 3 阶段，有 6 个治疗中心的 14 名参与者接受了访谈。进行了两次 90 分钟的虚拟小组讨论。所有参与者都认为 cilta-cel 可以安全有效地在门诊环境中使用。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、建立专门的门诊基础设施和多学科团队、进行毒性管理的门诊监测，以及监测报销情况。
本研究全面了解了参与 CAR T 中心 cilta-cel 门诊管理的可行性，并提供了可行的建议，同时承认了现有挑战。
