[曲妥珠单抗德鲁司坦临床路径及不良反应管理中国专家共识(2024 年版)]。

Q3 Medicine
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引用次数: 0

摘要

曲妥珠单抗德鲁司坦(Trastuzumab deruxtecan,T-DXd)是新一代靶向人类表皮生长因子受体2(HER-2)的抗体药物共轭物(ADC)之一,具有旁观者效应。T-DXd 不仅能显著提高 HER-2 阳性晚期乳腺癌患者的生存率,还能使 HER-2 低表达的晚期乳腺癌患者从 HER-2 靶向治疗中获益。国家医药产品管理局已批准 T-DXd 用于治疗 HER-2 阳性或 HER-2 低表达的乳腺癌患者。可以预见,T-DXd 将在未来的临床实践中得到广泛应用。然而,与以往的 HER-2 靶向药物相比,T-DXd 在临床试验中也表现出了不同的安全性特征。如何更合理地管理T-DXd的不良反应,充分发挥T-DXd的疗效,是一个亟待解决的临床问题。专家组在现有临床证据和指南共识的基础上,结合临床实践经验,经过多次讨论,最终达成了曲妥珠单抗德鲁司康临床护理路径及不良反应管理共识。该共识内容包括T-DXd的临床使用方法、治疗前患者教育、T-DXd常见或值得注意的不良反应处理等。不良事件包括输液相关不良事件、消化系统不良事件(恶心/呕吐、便秘、腹泻、食欲下降)、血液系统不良事件(中性粒细胞减少、发热性中性粒细胞减少、贫血、血小板减少)、呼吸系统不良事件(间质性肺病/肺炎)、心血管不良事件(左心室射血分数下降)、肝功能不良事件(转氨酶升高)和其他常见不良事件(脱发、疲劳等)。本共识重点关注不良事件的预防、不良事件发生时的剂量调整和治疗,以及对患者生活方式的建议,旨在提高临床医生对T-DXd的认识,为临床肿瘤医生的T-DXd临床管理提供实用指导。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
[Chinese expert consensus on the management of clinical pathway and adverse events of trastuzumab deruxtecan (2024 edition)].

Trastuzumab deruxtecan (T-DXd) is one of the new generation antibody-drug conjugates (ADCs) targeting human epidermal growth factor receptor 2 (HER-2) with bystander effect. T-DXd can not only significantly improve the survival of HER-2-positive advanced breast cancer patients, but also enable advanced breast cancer patients with low HER-2 expression to benefit from HER-2-targeted therapy. T-DXd has been approved by the National Medical Products Administration (NMPA) for the treatment of HER-2-positive or HER-2-low breast cancer patients. It is foreseeable that T-DXd will be widely used in clinical practice in the future. However, T-DXd has also shown different safety characteristics compared to previous HER-2 targeted drugs in clinical trials. How to manage T-DXd adverse events more reasonably and fully utilize the efficacy of T-DXd is an urgent clinical problem. Based on the existing clinical evidence and guideline consensus, combined with clinical practice experience, the expert group finally reached the consensus of clinical care pathway and adverse reaction management of trastuzumab deruxtecan after many discussions. This consensus content includes the clinical use method of T-DXd, pre-treatment patient education, and management of common or noteworthy adverse events of T-DXd. The adverse events include infusion related adverse events, digestive system adverse events (nausea/vomiting, constipation, diarrhea, and decreased appetite), hematological adverse events (neutropenia, febrile neutropenia, anemia, thrombocytopenia), respiratory adverse events (interstitial lung disease/pneumonia), cardiovascular adverse events (decreased left ventricular ejection fraction), adverse events in liver function (elevated transaminases) and other common adverse events (alopecia, fatigue, etc). This consensus focuses on the prevention of adverse events, dose adjustment and treatment when adverse events occur, and recommendations for patients' lifestyle, aiming to improve clinicians' understanding of T-DXd and provide practical guidance for clinical oncologists on T-DXd clinical management.

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来源期刊
中华肿瘤杂志
中华肿瘤杂志 Medicine-Medicine (all)
CiteScore
1.40
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0.00%
发文量
10433
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