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双特异性T细胞衔接抗体在社区实践中的应用与操作:细胞因子释放综合征管理的物流与工作流程开发的多学科视角

Operationalization and Use of Bispecific T-Cell-Engaging Antibodies in Community Practices: Multidisciplinary Perspectives on Developing Logistics and Workflow for Cytokine Release Syndrome Management.

作者信息

Donnellan William, Lin Shih-Wen, Abbas Jonathan, Berdeja Jesus G, Cassoli Lourenia, Chandler Jason C, Flores Brannon, Hall Sara, Ravelo Arliene, Masaquel Anthony, Patterson Sharifa, Peng Eileen, Todd Ashley, Traughber Chelsea, Raff Lisa

机构信息

From Tennessee Oncology, Nashville, Tennessee.

Genentech, Inc., South San Francisco, California.

出版信息

J Adv Pract Oncol. 2025 Jun 25:1-9. doi: 10.6004/jadpro.2025.16.7.19.


DOI:10.6004/jadpro.2025.16.7.19
PMID:40771749
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12323733/
Abstract

OBJECTIVES: Operationalizing workflows to manage cytokine release syndrome (CRS) in community practices presents challenges for multidisciplinary teams. Real-world experience was gathered from OneOncology community health-care professionals to establish best-prac-tice workflows for CRS management. METHODS: Qualitative data were gathered via focus groups from hematology-oncology MDs, PharmDs, and nurse providers ( = 13) with experience treating patients with bispecific T-cell-engaging antibodies (BsAbs). Theme matrix techniques facilitated analysis. RESULTS: Three themes were identified: (1) creating a coordinated workflow plan, (2) building network partnerships, and (3) understanding patient support. Workflow decisions were driven by community practices managing patients treated with BsAbs or partnering with sites for initial dosing and maintenance. Catalysts for developing CRS workflows included: FDA approval of BsAbs; BsAbs clinical trial experience; BsAbs on formulary; having patients receiving BsAbs; and practice champion(s) for protocol development. Key steps included defining communication during and after practice hours, designating training leads, and creating practice-specific plans for interdisciplinary team coordination. Inpatient admission processes developed with hospital staff and hospital staff training were fundamental for successful patient management. Communication processes among practice, pharmacy, and hospital staff throughout BsAbs treatment were established, along with methods to ensure the availability of CRS treatment if needed. Continuous patient/caregiver education on BsAbs treatment, monitoring for adverse events (particularly CRS), and how/when to access care were described. CONCLUSIONS: BsAb use in community settings requires multidisciplinary coordination between practices and hospitals. Actions included identifying practice champions, establishing clear workflows for transitioning patients between inpatient and outpatient settings, and ensuring continuous training of staff, patients, and caregivers.

摘要

目的:在社区医疗机构中实施管理细胞因子释放综合征(CRS)的工作流程,对多学科团队而言具有挑战性。从OneOncology社区医疗保健专业人员那里收集了实际经验,以建立CRS管理的最佳实践工作流程。 方法:通过焦点小组收集了血液肿瘤学医学博士、药学博士和护士提供者(n = 13)的定性数据,他们均有使用双特异性T细胞衔接抗体(BsAbs)治疗患者的经验。主题矩阵技术有助于分析。 结果:确定了三个主题:(1)制定协调的工作流程计划,(2)建立网络伙伴关系,以及(3)了解患者支持情况。工作流程决策由管理接受BsAbs治疗患者的社区医疗机构或与初始给药和维持治疗地点合作的机构推动。制定CRS工作流程的催化剂包括:FDA对BsAbs的批准;BsAbs的临床试验经验;列入处方集的BsAbs;有接受BsAbs治疗的患者;以及方案制定的实践倡导者。关键步骤包括定义工作时间内和工作时间后的沟通方式、指定培训负责人,以及制定针对跨学科团队协调的特定实践计划。与医院工作人员共同制定的住院入院流程以及医院工作人员培训,是成功管理患者的基础。建立了BsAbs治疗期间实践机构、药房和医院工作人员之间的沟通流程,以及在需要时确保提供CRS治疗的方法。描述了对患者/护理人员进行关于BsAbs治疗、不良事件(特别是CRS)监测以及如何/何时获得护理的持续教育。 结论:在社区环境中使用BsAb需要实践机构和医院之间进行多学科协调。行动包括确定实践倡导者、建立患者在住院和门诊环境之间转换的明确工作流程,以及确保对工作人员、患者和护理人员进行持续培训。

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本文引用的文献

[1]
Bispecific Antibody Use in Patients With Lymphoma and Multiple Myeloma.

Am Soc Clin Oncol Educ Book. 2024-6

[2]
Consensus recommendations on the management of toxicity associated with CD3×CD20 bispecific antibody therapy.

Blood. 2024-4-18

[3]
Tarlatamab for Patients with Previously Treated Small-Cell Lung Cancer.

N Engl J Med. 2023-11-30

[4]
Safety and efficacy of T-cell-redirecting bispecific antibodies for patients with multiple myeloma: a systematic review and meta-analysis.

Cancer Cell Int. 2023-9-5

[5]
T-cell-engaging bispecific antibodies in cancer.

Lancet. 2023-7-8

[6]
T-cell-engaging antibodies for the treatment of solid tumors: challenges and opportunities.

Curr Opin Oncol. 2022-9-1

[7]
Bispecific Antibodies: A Review of Development, Clinical Efficacy and Toxicity in B-Cell Lymphomas.

J Pers Med. 2021-4-29

[8]
CAR T-Cell Therapy: Adverse Events and Management.

J Adv Pract Oncol. 2019

[9]
Tocilizumab for the treatment of chimeric antigen receptor T cell-induced cytokine release syndrome.

Expert Rev Clin Immunol. 2019-6-20

[10]
ASTCT Consensus Grading for Cytokine Release Syndrome and Neurologic Toxicity Associated with Immune Effector Cells.

Biol Blood Marrow Transplant. 2018-12-25

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