Rebecca S. Heist , Jacob Sands , Aditya Bardia , Toshio Shimizu , Aaron Lisberg , Ian Krop , Noboru Yamamoto , Takahiro Kogawa , Saba Al-Hashimi , Simon S.M. Fung , Anat Galor , Francesca Pisetzky , Priyanka Basak , Cindy Lau , Funda Meric-Bernstam
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引用次数: 0
摘要
抗体药物共轭物(ADC)是一种新兴的治疗方法,与其他全身治疗方法相比,它通过选择性地向肿瘤细胞输送细胞毒性药物来提高疗效和降低毒性。Datopotamab deruxtecan(Dato-DXd)是一种新型ADC,由拓扑异构酶I抑制剂有效载荷和针对滋养层母细胞表面抗原2(TROP2)的单克隆抗体组成。Dato-DXd 正在多个实体瘤适应症中进行研究。在正在进行的首个人体 TROPION-PanTumor01 I 期研究(ClinicalTrials.gov:NCT03401385)中,激素受体阳性/人类表皮生长因子受体2阴性的晚期/转移性乳腺癌(HR+/HER2- BC)、三阴性乳腺癌(TNBC)和非小细胞肺癌(NSCLC)患者表现出令人鼓舞的持久抗肿瘤活性和可控的安全性。
Clinical management, monitoring, and prophylaxis of adverse events of special interest associated with datopotamab deruxtecan
Antibody drug conjugates (ADCs) are an emerging class of treatments designed to improve efficacy and decrease toxicity compared with other systemic therapies through the selective delivery of cytotoxic agents to tumor cells. Datopotamab deruxtecan (Dato-DXd) is a novel ADC comprising a topoisomerase I inhibitor payload and a monoclonal antibody directed to trophoblast cell-surface antigen 2 (TROP2), a protein that is broadly expressed in several types of solid tumors. Dato-DXd is being investigated across multiple solid tumor indications. In the ongoing, first-in-human TROPION-PanTumor01 phase I study (ClinicalTrials.gov: NCT03401385), encouraging and durable antitumor activity and a manageable safety profile was demonstrated in patients with advanced/metastatic hormone receptor-positive/human epidermal growth factor receptor 2-negative breast cancer (HR+/HER2– BC), triple-negative breast cancer (TNBC), and non-small cell lung cancer (NSCLC).
Improved understanding of the adverse events (AEs) that are associated with Dato-DXd and their optimal management is essential to ensure safe and successful administration. Interstitial lung disease/pneumonitis, infusion-related reactions, oral mucositis/stomatitis, and ocular surface events have been identified as AEs of special interest (AESIs) for which appropriate prevention, monitoring, and management is essential. This article summarizes the incidence of AESIs among patients with HR+/HER2− BC, TNBC, and NSCLC reported in TROPION-PanTumor01. We report our recommendations for AESI prophylaxis, early detection, and management, using experience gained from treating AESIs that occur with Dato-DXd in clinical trials.
期刊介绍:
Cancer Treatment Reviews
Journal Overview:
International journal focused on developments in cancer treatment research
Publishes state-of-the-art, authoritative reviews to keep clinicians and researchers informed
Regular Sections in Each Issue:
Comments on Controversy
Tumor Reviews
Anti-tumor Treatments
New Drugs
Complications of Treatment
General and Supportive Care
Laboratory/Clinic Interface
Submission and Editorial System:
Online submission and editorial system for Cancer Treatment Reviews