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曲妥珠单抗-德鲁替康相关不良事件的预防、监测和管理的临床实践和机构方案。

Clinical Practices and Institutional Protocols on Prophylaxis, Monitoring, and Management of Selected Adverse Events Associated with Trastuzumab Deruxtecan.

机构信息

Massachusetts General Hospital Cancer Center, Harvard Medical School, Harvard University, Boston, MA, USA.

Breast Oncology Program, Inova Schar Cancer Institute, Fairfax, VA, USA.

出版信息

Oncologist. 2022 Aug 5;27(8):637-645. doi: 10.1093/oncolo/oyac107.

Abstract

The treatment of metastatic breast cancer (mBC) has evolved significantly in the past several years with the approval of new targeted agents. Trastuzumab deruxtecan (T-DXd), an antibody-drug conjugate with a topoisomerase I inhibitor payload, is a new addition to the class of therapies that target the human epidermal growth factor 2 (HER2) receptor. T-DXd was approved in the US in December 2019 for patients with HER2-positive metastatic or unresectable breast cancer who have received 2 or more prior anti-HER2-based regimens in the metastatic setting. In the DESTINY-Breast01 phase II trial (NCT03248492), T-DXd demonstrated high rates of durable responses in heavily pretreated patients with HER2-positive mBC, with a confirmed objective response rate of 62%, median duration of response of 18.2 months, and median progression-free survival of 19.4 months. In addition to efficacy, successful implementation of any new anticancer therapy includes learning how to prevent, monitor, and manage treatment-related adverse events. As T-DXd becomes more widely used, information can be gained from real-world clinical practices, institutional approaches, and the collaboration of multidisciplinary oncology teams who treat patients with T-DXd. This article reviews practical insights and management of nausea and vomiting, neutropenia, interstitial lung disease, risk of cardiotoxicity, and other adverse events associated with T-DXd administration from the perspective of health care providers who have experience utilizing T-DXd.

摘要

在过去的几年中,随着新的靶向药物的批准,转移性乳腺癌(mBC)的治疗发生了重大变化。曲妥珠单抗-美坦新偶联物(T-DXd)是一种新型的靶向人表皮生长因子 2(HER2)受体的治疗药物,它是一种抗体药物偶联物,带有拓扑异构酶 I 抑制剂有效载荷。T-DXd 于 2019 年 12 月在美国获得批准,用于接受过 2 种或更多种先前在转移性环境中基于抗 HER2 的方案治疗的 HER2 阳性转移性或不可切除乳腺癌患者。在 DESTINY-Breast01 期 II 期试验(NCT03248492)中,T-DXd 在 HER2 阳性 mBC 的大量预处理患者中显示出持久应答的高比率,确认的客观缓解率为 62%,中位缓解持续时间为 18.2 个月,中位无进展生存期为 19.4 个月。除了疗效之外,任何新的抗癌疗法的成功实施都包括学习如何预防、监测和管理与治疗相关的不良事件。随着 T-DXd 的应用越来越广泛,可以从真实世界的临床实践、机构方法以及治疗接受 T-DXd 治疗的患者的多学科肿瘤团队的协作中获得信息。本文从使用过 T-DXd 的医疗保健提供者的角度,综述了与 T-DXd 给药相关的恶心和呕吐、中性粒细胞减少、间质性肺病、心脏毒性风险和其他不良事件的实用见解和管理。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/63c8/9355822/0a197bc7f491/oyac107f0001.jpg

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