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为非霍奇金淋巴瘤患者的CD20-CD3双特异性抗体治疗培养护士:对早期和关键试验中的不良事件及管理策略的范围综述

Preparing Nurses for CD20-CD3 Bispecific Antibody Treatment in Patients With Non-Hodgkin Lymphoma: A Scoping Review of Adverse Events and Management Strategies From Early Phase and Pivotal Trials.

作者信息

van der Linde Sam, Knights Emily, Robertson Molly, Krishnasamy Meinir, Minson Adrian, Dickinson Michael

机构信息

Author Affiliations: Parkville Cancer Clinical Trials Unit, Peter MacCallum Cancer Centre (Mss van der Linde and Robertson, Messrs Minson and Dickinson, and Dr Krishnasamy); Barwon Health, University Hospital Geelong (Ms Knights); Department of Health Services Research, Peter MacCallum Cancer Centre, Parkville (Dr Krishnasamy); and Victorian Comprehensive Cancer Centre Alliance (Dr Krishnasamy); and Sir Peter MacCallum Department of Oncology, University of Melbourne (Dr Krishnasamy), Australia.

出版信息

Cancer Nurs. 2024 Dec 30. doi: 10.1097/NCC.0000000000001419.

DOI:10.1097/NCC.0000000000001419
PMID:39601563
Abstract

BACKGROUND

Bispecific T-cell engaging antibodies (BsAbs) are novel agents used to treat B-cell non-Hodgkin lymphoma (B-NHL); these agents demonstrate a different toxicity profile compared with standard chemoimmunotherapy.

OBJECTIVE

To describe common adverse events (AEs) experienced by patients with B-NHL during BsAb treatment.

METHODS

MEDLINE, EMCARE, and EMBASE were searched for relevant studies. Prospective interventional clinical trials of CD20-CD3 BsAbs in late development reporting on safety data for B-NHL patients, published until March 2023, were included.

RESULTS

This search identified 1481 records; 28 met the inclusion criteria. Cytokine release syndrome (CRS), neutropenia, pyrexia, and anemia were the most commonly reported AEs. CRS primarily occurred during the first cycle of treatment and was mostly low grade; 14 publications (48%) reported a grade ≥3; however, these occurred in less than 10% of patients. Mitigation strategies included premedication with corticosteroids, antipyretics, and antihistamines; step-up dosing; and planned hospitalizations. Two articles reported common signs and symptoms of CRS, which included pyrexia (98% and 99%), chills (13% and 35%), tachycardia (27% and 28%), and hypotension (24% and 38%). Supportive management, tocilizumab, and corticosteroids were widely used (reported in 16/28 studies) for the treatment of CRS. Patient risk factors for CRS included high tumor burden, bone marrow infiltration, and circulating disease.

CONCLUSIONS

The AE profile of BsAbs requires specialized nurses, skilled in assessing patients for risk factors and recognizing signs and symptoms of AEs.

IMPLICATIONS FOR PRACTICE

Findings from this review will contribute to cancer nurses' knowledge of CD20-CD3 BsAbs for B-NHL, optimizing the quality and safety of patient care.

摘要

背景

双特异性T细胞衔接抗体(BsAbs)是用于治疗B细胞非霍奇金淋巴瘤(B-NHL)的新型药物;与标准化学免疫疗法相比,这些药物表现出不同的毒性特征。

目的

描述B-NHL患者在BsAb治疗期间经历的常见不良事件(AE)。

方法

检索MEDLINE、EMCARE和EMBASE以查找相关研究。纳入截至2023年3月发表的关于B-NHL患者安全性数据的CD20-CD3 BsAbs晚期开发的前瞻性干预性临床试验。

结果

该检索识别出1481条记录;28条符合纳入标准。细胞因子释放综合征(CRS)、中性粒细胞减少、发热和贫血是最常报告的AE。CRS主要发生在治疗的第一个周期,且大多为低级别;14篇出版物(48%)报告了≥3级;然而,这些情况发生在不到10%的患者中。缓解策略包括使用皮质类固醇、退烧药和抗组胺药进行预处理;逐步增加剂量;以及计划住院治疗。两篇文章报告了CRS的常见体征和症状,包括发热(98%和99%)、寒战(13%和35%)、心动过速(27%和28%)和低血压(24%和38%)。支持性管理、托珠单抗和皮质类固醇被广泛用于治疗CRS(在16/28项研究中报告)。CRS的患者风险因素包括高肿瘤负荷、骨髓浸润和循环疾病。

结论

BsAbs的AE特征需要专业护士,他们擅长评估患者的风险因素并识别AE的体征和症状。

对实践的启示

本综述的结果将有助于癌症护士了解用于B-NHL的CD20-CD3 BsAbs,优化患者护理的质量和安全性。

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