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

DOI Web Site 参考文献28件
  • Takuya Maeda
    Department of Dermatology, Faculty of Medicine and Graduate School of Medicine Hokkaido University Sapporo Japan
  • Teruki Yanagi
    Department of Dermatology, Faculty of Medicine and Graduate School of Medicine Hokkaido University Sapporo Japan
  • Keiko Tokuchi
    Department of Dermatology, Faculty of Medicine and Graduate School of Medicine Hokkaido University Sapporo Japan
  • Takeru Funakoshi
    Department of Dermatology Keio University School of Medicine Tokyo Japan
  • Nao Horie
    Clinical Research and Medical Innovation Center Promotion Unit Institute of Health Science Innovation for Medical Care Hokkaido University Hospital Sapporo Japan
  • Toshiyuki Isoe
    Clinical Research and Medical Innovation Center Promotion Unit Institute of Health Science Innovation for Medical Care Hokkaido University Hospital Sapporo Japan
  • Yoichi M. Ito
    Data Science Center, Promotion Unit Institute of Health Science Innovation for Medical Care Hokkaido University Hospital Sapporo Japan
  • Norihiro Sato
    Institute of Health Science Innovation for Medical Care Hokkaido University Hospital Sapporo Japan
  • Hideyuki Ujiie
    Department of Dermatology, Faculty of Medicine and Graduate School of Medicine Hokkaido University Sapporo Japan

この論文をさがす

説明

<jats:title>Abstract</jats:title><jats:p>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.</jats:p>

収録刊行物

参考文献 (28)*注記

もっと見る

関連プロジェクト

もっと見る

キーワード

詳細情報 詳細情報について

問題の指摘

ページトップへ