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替索妥单抗维朵汀在临床实践中的安全性和耐受性:不良事件的管理

Tisotumab Vedotin Safety and Tolerability in Clinical Practice: Managing Adverse Events.

作者信息

Arn Courtney R, Halla Kimberly J, Gill Sally

机构信息

Wexner Medical Center, The Ohio State University, Columbus, Ohio.

Arizona Oncology, Phoenix, Arizona.

出版信息

J Adv Pract Oncol. 2023 Mar;14(2):139-152. doi: 10.6004/jadpro.2023.14.2.4. Epub 2023 Mar 1.

Abstract

Tisotumab vedotin-tftv, an antibody-drug conjugate indicated for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy, demonstrated clinically meaningful and durable responses with a manageable safety profile in the pivotal phase II innovaTV 204 clinical trial. Based on the proposed mechanism of action of tisotumab vedotin, experience from clinical trials, and the US prescribing information, certain adverse events (AEs) including ocular AEs, peripheral neuropathy, and bleeding have been identified as AEs of interest. This article highlights practical considerations and provides recommendations to support the management of selected AEs associated with tisotumab vedotin. Central to monitoring of patients on tisotumab vedotin is a comprehensive care team comprised of oncologists, advanced practice providers (including nurse practitioners, physician assistants, and pharmacists), and other specialists such as ophthalmologists. As ocular AEs may be less familiar to gynecologic oncology practitioners, adherence to the "Premedication and Required Eye Care" section outlined in the US prescribing information, as well as the incorporation of ophthalmologists into the oncology care team, can help provide timely and appropriate eye care for patients receiving tisotumab vedotin.

摘要

替索妥单抗(Tisotumab vedotin-tftv)是一种抗体药物偶联物,适用于治疗化疗后疾病进展的复发或转移性宫颈癌成年患者。在关键的II期innovaTV 204临床试验中,它显示出具有临床意义且持久的疗效,安全性易于管理。基于替索妥单抗的作用机制、临床试验经验以及美国处方信息,已确定某些不良事件(AE),包括眼部AE、周围神经病变和出血,为关注的AE。本文重点介绍了实际注意事项,并提供了支持管理与替索妥单抗相关的特定AE的建议。对接受替索妥单抗治疗的患者进行监测的核心是一个由肿瘤学家、高级执业人员(包括执业护士、医师助理和药剂师)以及其他专家(如眼科医生)组成的综合护理团队。由于妇科肿瘤学从业者可能对眼部AE不太熟悉,遵循美国处方信息中概述的“预处理和所需眼部护理”部分,以及将眼科医生纳入肿瘤护理团队,有助于为接受替索妥单抗治疗的患者提供及时和适当的眼部护理。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2cb9/10062530/1f8c89e242ad/jadpro-14-139-g001.jpg

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