Department of Hepatobiliary & Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan.
Division of Hepatobiliary & Pancreatic Oncology, Kanagawa Cancer Center, Yokohama, Japan.
Future Oncol. 2022 Jun;18(19):2351-2360. doi: 10.2217/fon-2022-0214. Epub 2022 May 5.
Trastuzumab deruxtecan (DS-8201) is an antibody-drug conjugate composed of a humanized monoclonal anti-HER2 antibody, a cleavable tetrapeptide-based linker and a potent topoisomerase I inhibitor. The drug's efficacy has been proven in HER2-positive breast and gastric cancers. The rate of HER2 positivity in biliary tract cancer (BTC) has been reported to be 5-20%, and case reports and clinical trials have suggested that HER2 inhibitors might be active in HER2-positive BTC. Here we describe the rationale and design of the phase II HERB trial that will evaluate the efficacy and safety of trastuzumab deruxtecan in patients with HER2-expressing unresectable or recurrent BTC. The primary end point will be the centrally assessed objective response rate in HER2-positive patients.
曲妥珠单抗-德鲁替康（DS-8201）是一种抗体药物偶联物，由人源化单克隆抗 HER2 抗体、可裂解的四肽连接子和一种强效拓扑异构酶 I 抑制剂组成。该药在 HER2 阳性乳腺癌和胃癌中的疗效已得到证实。胆道癌（BTC）中 HER2 阳性率已报道为 5-20%，病例报告和临床试验表明，HER2 抑制剂可能对 HER2 阳性 BTC 有效。本研究旨在描述 II 期 HERB 试验的原理和设计，该试验将评估曲妥珠单抗-德鲁替康在 HER2 表达不可切除或复发性 BTC 患者中的疗效和安全性。主要终点为中心评估的 HER2 阳性患者的客观缓解率。
