Real-World Safety and Early Effectiveness of First-Line Enfortumab Vedotin Plus Pembrolizumab with Routine Dexamethasone Premedication in Advanced Urothelial Carcinoma

Hara, Takuto; Wakita, Naoto; Tobe, Taisuke; Ueki, Hideto; Okamura, Yasuyoshi; Bando, Yukari; Suzuki, Kotaro; Terakawa, Tomoaki; Hyodo, Yoji; Yao, Akihisa; Chiba, Koji; Teishima, Jun; Miyake, Hideaki

https://hdl.handle.net/20.500.14094/0100502497

このアイテムのアクセス数:59件（2026-04-06 17:47 集計）

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メタデータID	0100502497
アクセス権	open access
出版タイプ	Version of Record
タイトル	Real-World Safety and Early Effectiveness of First-Line Enfortumab Vedotin Plus Pembrolizumab with Routine Dexamethasone Premedication in Advanced Urothelial Carcinoma
著者	Hara, Takuto ; Wakita, Naoto ; Tobe, Taisuke ; Ueki, Hideto ; Okamura, Yasuyoshi ; Bando, Yukari ; Suzuki, Kotaro ; Terakawa, Tomoaki ; Hyodo, Yoji ; Yao, Akihisa ; Chiba, Koji ; Teishima, Jun ; Miyake, Hideaki
著者ID A2827 研究者ID 1000090791848 KUID https://kuid-rm-web.ofc.kobe-u.ac.jp/search/detail.html?systemId=63485f953fa4e883520e17560c007669 著者名 Hara, Takuto 原, 琢人ハラ, タクト所属機関名医学部附属病院
著者ID A3866 研究者ID 1000030990759 KUID https://kuid-rm-web.ofc.kobe-u.ac.jp/search/detail.html?systemId=eaa6b227361ac75b520e17560c007669 著者名 Wakita, Naoto 脇田, 直人ワキタ, ナオト所属機関名医学部附属病院
著者名 Tobe, Taisuke
著者ID A3708 研究者ID 1000000903296 ORCID 0000-0002-7742-4528 KUID https://kuid-rm-web.ofc.kobe-u.ac.jp/search/detail.html?systemId=8f5865d4a317e043520e17560c007669 著者名 Ueki, Hideto 植木, 秀登ウエキ, ヒデト所属機関名医学部附属病院
著者ID A2764 研究者ID 1000090806100 KUID https://kuid-rm-web.ofc.kobe-u.ac.jp/search/detail.html?systemId=2bd3874fc988f194520e17560c007669 著者名 Okamura, Yasuyoshi 岡村, 泰義オカムラ, ヤスヨシ所属機関名医学研究科
著者ID A3097 研究者ID 1000080792457 KUID https://kuid-rm-web.ofc.kobe-u.ac.jp/search/detail.html?systemId=94b7086495c5c7ce520e17560c007669 著者名 Bando, Yukari 板東, 由加里バンドウ, ユカリ所属機関名医学研究科
著者ID A3670 研究者ID 1000020791841 ORCID 0000-0003-4589-9251 KUID https://kuid-rm-web.ofc.kobe-u.ac.jp/search/detail.html?systemId=e134a3ec9469b226520e17560c007669 著者名 Suzuki, Kotaro 鈴木, 光太郎スズキ, コウタロウ所属機関名医学部附属病院
著者ID A1444 研究者ID 1000050533759 KUID https://kuid-rm-web.ofc.kobe-u.ac.jp/search/detail.html?systemId=b9f3ad9a5e9a493a520e17560c007669 著者名 Terakawa, Tomoaki 寺川, 智章テラカワ, トモアキ所属機関名医学部附属病院
著者ID A3223 研究者ID 1000070444601 KUID https://kuid-rm-web.ofc.kobe-u.ac.jp/search/detail.html?systemId=866427e2b3c6bfe1520e17560c007669 著者名 Hyodo, Yoji 兵頭, 洋二ヒョウドウ, ヨウジ所属機関名医学部附属病院
著者ID A3949 研究者ID 1000070600261 KUID https://kuid-rm-web.ofc.kobe-u.ac.jp/search/detail.html?systemId=50df24e48fa8dc7d520e17560c007669 著者名 Yao, Akihisa 八尾, 昭久ヤオ, アキヒサ所属機関名医学研究科
著者ID A1456 研究者ID 1000040533766 KUID https://kuid-rm-web.ofc.kobe-u.ac.jp/search/detail.html?systemId=6882e55a28cc159f520e17560c007669 著者名 Chiba, Koji 千葉, 公嗣チバ, コウジ所属機関名医学研究科
著者ID A3484 研究者ID 1000020397962 KUID https://kuid-rm-web.ofc.kobe-u.ac.jp/search/detail.html?systemId=0b9580731fa70c91520e17560c007669 著者名 Teishima, Jun 亭島, 淳テイシマ, ジュン所属機関名医学研究科
著者ID A3648 研究者ID 1000060379435 KUID https://kuid-rm-web.ofc.kobe-u.ac.jp/search/detail.html?systemId=bca3146138aabb68520e17560c007669 著者名 Miyake, Hideaki 三宅, 秀明ミヤケ, ヒデアキ所属機関名医学研究科
言語	English (英語)
収録物名	Cancers
巻(号)	18(5)
ページ	739
出版者	MDPI
刊行日	2026-02-25
公開日	2026-03-04
抄録	Background: Enfortumab vedotin plus pembrolizumab (EVP) has become a first-line standard for metastatic or unresectable urothelial carcinoma. However, EVP is associated with distinct toxicities, particularly cutaneous adverse events, and prophylactic systemic corticosteroids were not permitted in pivotal trials. Therefore, the safety and early effectiveness of EVP with routine dexamethasone premedication in real-world practice remain unclear. Methods: This multicenter retrospective study included consecutive patients with metastatic or unresectable urothelial carcinoma who received first-line EVP at five institutions in Japan between September 2024 and September 2025. All patients received routine intravenous dexamethasone premedication before enfortumab vedotin administration. Safety and early clinical outcomes were evaluated, with exploratory subgroup analyses according to clinical trial eligibility and EVITA criteria. Results: Seventy-seven patients were included, with a median age of 75 years, and more than half would have been ineligible for pivotal clinical trials. Cutaneous toxicity was the most frequent adverse event (52.0%), whereas grade ≥3 skin reactions were uncommon (3.9%). With a median follow-up of 6.7 months, the objective response rate was 73.0%. The 6-month progression-free survival and overall survival rates were 73.9% and 78.7%, respectively. Early progression-free survival was generally maintained across subgroups stratified by clinical trial eligibility and EVITA category, with no evidence of excess early progression. Conclusions: In this real-world multicenter cohort, first-line EVP with routine dexamethasone premedication was feasible, with manageable toxicity and encouraging early clinical activity, including in patients with comorbidities commonly encountered in routine clinical practice. Longer follow-up and prospective comparative studies are warranted to clarify long-term outcomes and the impact of dexamethasone on efficacy and toxicity.
キーワード	urothelial carcinoma
	enfortumab vedotin
	pembrolizumab
	real-world data
	dexamethasone
	EVITA
カテゴリ	医学研究科
	医学部附属病院
	学術雑誌論文
権利	© 2026 by the authors. Licensee MDPI, Basel, Switzerland.
権利	This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license
関連情報	DOI https://doi.org/10.3390/cancers18050739

資源タイプ	journal article
eISSN	2072-6694　OPACで所蔵を検索　 CiNiiで学外所蔵を検索

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