Graff Tara, Flinn Ian, Sharman Jeff P, Liu Steven, Anz Bertrand M, Gandhi Mitul, Ayed Ayed, Zuniga Richard, Mansoor Abdul Hai, Cassoli Lourenia M, Wu Mei, Jani Prachi, Biondo Juliana M L, Lin Tony, Burke John M
Mission Cancer and Blood, Des Moines, Iowa, USA.
Tennessee Oncology/OneOncology, Nashville, Tennessee, USA.
Cancer Med. 2025 Jun;14(11):e70936. doi: 10.1002/cam4.70936.
BACKGROUND: Preliminary data from the MorningSun study have demonstrated that outpatient subcutaneous mosunetuzumab can be safely administered. AIMS: This publication describes how community centers in the MorningSun phase 2 study of outpatient subcutaneous mosunetuzumab in B-cell non-Hodgkin lymphomas prepared workflow and logistics (staff coordination, practice networks, and patient support) to monitor patients for cytokine release syndrome (CRS) and other toxicities. MATERIALS AND METHODS: Ten investigators at US community practice study sites (one rural, seven urban, and two rural/urban) were interviewed between January 12 and February 22, 2024. Interview transcripts were analyzed qualitatively to identify key themes. RESULTS: Prior to the study, 7/10 had limited/no experience administering bispecific antibodies for lymphoma. Regarding preparation before treatment, staff education was the most frequent need (7/10). All sites provided in-service training for staff involved with treatment administration. Most respondents (6/10) had multidisciplinary plans and agreed these eased logistical concerns. Out of hours, patients either called the triage team, a dedicated on-call number, the physician, or the emergency department. Most practices had preexisting relationships with hospitals for CRS management. All practices established methods for outpatient CRS monitoring; patient education and caregivers played important roles, and all respondents encouraged patients to use self-monitoring devices. Each community practice had different workflow and logistics based on their setting and infrastructure. CONCLUSION: Community practices can leverage other sites' experiences and adopt an individualized approach to implementing bispecific antibodies safely and efficiently. Designating a physician champion could provide a local resource to address staff questions and concerns.
背景:MorningSun研究的初步数据表明,门诊皮下注射莫苏奈妥珠单抗可以安全给药。 目的:本出版物描述了MorningSun 2期研究中社区中心在门诊皮下注射莫苏奈妥珠单抗治疗B细胞非霍奇金淋巴瘤时,如何准备工作流程和后勤保障(人员协调、实践网络和患者支持)以监测患者的细胞因子释放综合征(CRS)和其他毒性反应。 材料与方法:2024年1月12日至2月22日期间,对美国社区实践研究站点的10名研究人员(1名来自农村、7名来自城市、2名来自城乡结合部)进行了访谈。对访谈记录进行定性分析以确定关键主题。 结果:研究前,10名中有7名在淋巴瘤双特异性抗体给药方面经验有限/无经验。关于治疗前的准备,员工培训是最常见的需求(10名中有7名)。所有站点都为参与治疗给药的员工提供了在职培训。大多数受访者(10名中有6名)有多学科计划,并认为这些计划缓解了后勤方面的担忧。非工作时间,患者要么致电分诊团队、专用值班号码、医生或急诊科。大多数医疗机构与医院在CRS管理方面有预先建立的关系。所有医疗机构都建立了门诊CRS监测方法;患者教育和护理人员发挥了重要作用,所有受访者都鼓励患者使用自我监测设备。每个社区实践根据其环境和基础设施有不同的工作流程和后勤保障。 结论:社区实践可以借鉴其他站点的经验,采用个性化方法安全有效地实施双特异性抗体治疗。指定一名医生负责人可以提供当地资源,以解决员工的问题和担忧。
Expert Opin Biol Ther. 2024-10
N Engl J Med. 2022-12-15