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临床医生与管理者对复发/难治性多发性骨髓瘤门诊使用 ciltacabtagene autoleucel 的观点

英文原题:Clinician and administrator perspectives on outpatient administration of ciltacabtagene autoleucel in relapsed or refractory multiple myeloma.

查看英文原题

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

PubMed 2024/06/10(内容时间) Front Immunol Q1 · IF 7(JCR 2025)

分数与星级只用于站内排序 —— 不代表疗效、安全性或个人适用性。

研究概要

本研究全面阐释了在参与研究的 CAR-T 中心门诊使用 cilta-cel 的可行性,并在承认现有挑战的同时提供了可操作的推荐意见。

中文摘要

第一阶段的针对性综述旨在识别美国门诊CAR-T 给药相关因素,并确定第二阶段探索性访谈及第三阶段专家讨论的重点;后两阶段聚焦cilta-cel门诊给药最佳实践与挑战。招募有cilta-cel真实世界门诊给药经验治疗中心的临床及行政人员。

第一阶段识别17项研究。门诊给药的关键因素包括制定CAR-T 并发症处理方案;为照护者、门诊专科人员、医院员工及急救服务人员提供培训,以识别并转诊潜在不良事件;建立多学科团队以有效沟通和管理;简化患者接收流程,包括财务资格审查和提供患者教育资料;以及全程密切监测患者。第二阶段访谈了来自2个中心的5名参与者;第三阶段访谈了来自6个治疗中心的14名参与者。随后开展两场各90分钟的线上专家讨论。所有参与者均认为cilta-cel可在门诊安全有效地实施。主要建议包括为患者及照护者制作教育资源、制定标准操作规程、配置专门门诊设施并组建跨学科团队、门诊监测和管理毒性,以及关注报销政策变化。 讨论:本研究全面评估了参与CAR-T 中心门诊给予cilta-cel的可行性,提出可执行建议,同时承认现存挑战。

展开英文摘要原文

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. DISCUSSION: 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.

论文信息

作者
Hansen DK、Dhakal B、Hamadani M、Dingli D、Jain T、Huff CA、Janakiram M、Liu YH
第一作者单位
Department of Blood and Marrow Transplant and Cellular Immunotherapy, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, United States.United States
通讯作者单位
Department of Lymphoma and Myeloma, The University of Texas MD Anderson Cancer Center, Houston, TX, United States.United States
文献类型
非美国政府资助研究
期刊
Frontiers in immunology2024
原文标识
PubMed 38915401 · DOI 10.3389/fimmu.2024.1405452