Eribulin for patients with metastatic extramammary Paget disease: Study protocol for a single‐arm phase II trial

艾瑞布林 医学 临床终点 内科学 肿瘤科 乳外佩吉特病 临床试验 多西紫杉醇 恶性肿瘤 代理终结点 临床研究阶段 外科 转移性乳腺癌 疾病 癌症 乳腺癌
作者
Takuya Maeda,Teruki Yanagi,Keiko Tokuchi,Takeru Funakoshi,Nao Horie,Toshiyuki Isoe,Yoichi M. Ito,Norihiro Sato,Hideyuki Ujiie
出处
期刊:Experimental Dermatology [Wiley]
卷期号:33 (1)
标识
DOI:10.1111/exd.14993
摘要

Abstract Extramammary Paget disease (EMPD) is a rare cutaneous malignancy that predominantly affects the anogenital areas of the elderly. Although the efficacy of docetaxel and other cytotoxic agents for advanced EMPD has been reported in small retrospective case studies, no treatment has been proven effective in prospective clinical trials. We established the world's first in vivo EMPD experimental model (a patient‐derived xenograft model). In our treatment experiment, xenograft tumours showed a remarkable response to eribulin. This study evaluates the efficacy of eribulin for patients with advanced EMPD. In October 2022, we started a single‐arm phase II trial to evaluate the efficacy of eribulin as a treatment for adult patients with unresectable EMPD with measurable lesions. Enrolment in this clinical trial is open to patients with any prior treatment for EMPD. The primary endpoint is overall response rate; the secondary endpoints include disease control rate, overall survival, progression‐free survival and adverse events. The study protocol was approved by the Ethics Committee of Hokkaido University and the other collaborating institutions. If the primary endpoint is met, it is our hope that eribulin will be regarded as a standard medication for patients with advanced EMPD.
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