{"title":"Clinical significance of the dose modification of enfortumab vedotin monotherapy for advanced urothelial carcinoma.","authors":"Akinori Minato, Tomohisa Takaba, Yoshihiro Sugita, Yuya Kaneko, Ryota Hongyo, Toshinobu Tanaka, Taro Bando, Takaomi Sugi, Yui Mizushima, Takuo Matsukawa, Kazumasa Jojima, Katsuyoshi Higashijima, Yujiro Nagata, Ikko Tomisaki, Eiji Kashiwagi","doi":"10.1093/jjco/hyaf049","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>This study aimed to assess the influence of modifying the dose of enfortumab vedotin (EV) monotherapy in patients with advanced urothelial carcinoma (UC).</p><p><strong>Methods: </strong>We retrospectively evaluated consecutive patients with metastatic UC who had received EV following platinum-based chemotherapy and immune checkpoint inhibitor therapy at our institution between December 2021 and June 2024. The relative dose intensity (RDI), the reason for dose adjustments, and the overall survival (OS) were analyzed.</p><p><strong>Results: </strong>Overall, 49 patients were enrolled, of which 16 (32.7%), 21 (42.9%), and 12 (24.4%) had RDI of >80%, 60%-80%, and <60%, respectively. EV was discontinued in 3 (6.1%), interrupted in 22 (44.9%), and reduced in dose in 26 (53.1%) patients. In particular, EV was interrupted because of adverse events (AEs) in 77% of patients, and patient preference or attending physician's discretion in 23%. EV dose reduction occurred in 77% of patients because of AEs and in 23% because of the attending physician's discretion. The median duration of EV exposure in patients with RDI of >80%, 60%-80%, and <60% was 3.8, 4.8, and 7.8 months, respectively. These three groups showed no significant difference in OS from EV introduction (median, 8.8 months vs. 12.9 months vs. 15.1 months; P = .104). The median duration of EV response was 9.9 months in patients with RDI < 60%.</p><p><strong>Conclusion: </strong>In cases of effective management, decreasing the RDI during EV monotherapy does not negatively impact the survival outcomes.</p>","PeriodicalId":14656,"journal":{"name":"Japanese journal of clinical oncology","volume":" ","pages":""},"PeriodicalIF":1.9000,"publicationDate":"2025-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Japanese journal of clinical oncology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1093/jjco/hyaf049","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"ONCOLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
Objective: This study aimed to assess the influence of modifying the dose of enfortumab vedotin (EV) monotherapy in patients with advanced urothelial carcinoma (UC).
Methods: We retrospectively evaluated consecutive patients with metastatic UC who had received EV following platinum-based chemotherapy and immune checkpoint inhibitor therapy at our institution between December 2021 and June 2024. The relative dose intensity (RDI), the reason for dose adjustments, and the overall survival (OS) were analyzed.
Results: Overall, 49 patients were enrolled, of which 16 (32.7%), 21 (42.9%), and 12 (24.4%) had RDI of >80%, 60%-80%, and <60%, respectively. EV was discontinued in 3 (6.1%), interrupted in 22 (44.9%), and reduced in dose in 26 (53.1%) patients. In particular, EV was interrupted because of adverse events (AEs) in 77% of patients, and patient preference or attending physician's discretion in 23%. EV dose reduction occurred in 77% of patients because of AEs and in 23% because of the attending physician's discretion. The median duration of EV exposure in patients with RDI of >80%, 60%-80%, and <60% was 3.8, 4.8, and 7.8 months, respectively. These three groups showed no significant difference in OS from EV introduction (median, 8.8 months vs. 12.9 months vs. 15.1 months; P = .104). The median duration of EV response was 9.9 months in patients with RDI < 60%.
Conclusion: In cases of effective management, decreasing the RDI during EV monotherapy does not negatively impact the survival outcomes.
期刊介绍:
Japanese Journal of Clinical Oncology is a multidisciplinary journal for clinical oncologists which strives to publish high quality manuscripts addressing medical oncology, clinical trials, radiology, surgery, basic research, and palliative care. The journal aims to contribute to the world"s scientific community with special attention to the area of clinical oncology and the Asian region.
JJCO publishes various articles types including:
・Original Articles
・Case Reports
・Clinical Trial Notes
・Cancer Genetics Reports
・Epidemiology Notes
・Technical Notes
・Short Communications
・Letters to the Editors
・Solicited Reviews