研究者情報

キクチ　エイジ   KIKUCHI EIJI   菊地栄次    所属   医学部医学科 腎泌尿器外科学    職種   主任教授
言語種別	日本語
発表タイトル	Final analysis of post-marketing surveillance (PMS) data for avelumab maintenance therapy in patients (pts) with advanced urothelial carcinoma (UC) in Japan
会議名	第112回日本泌尿器科学会総会
学会区分	全国規模の学会
発表形式	口頭
講演区分	一般
発表者・共同発表者	Kikuchi Eiji, Nagata Masayoshi, Ito Taito, Sato Masashi, Ogi Mie, Morita Makiko, Kajita Masahiro, Nishiyama Hiroyuki
発表年月日	2025/04/18
開催地 （都市, 国名）	福岡県福岡市
開催期間	2025/04/17～2025/04/19
概要	OBJECTIVES: Avelumab maintenance therapy is the standard of care for advanced UC that has not progressed after prior chemotherapy based on the JAVELIN Bladder 100 phase 3 trial. We report final analyses of PMS data for the safety and effectiveness of avelumab maintenance in pts with UC in clinical practice in Japan. METHODS: This multicenter, observational PMS included pts with UC who received ≧1 dose of avelumab from February to December 2021. Data were collected for safety and effectiveness from the start of avelumab therapy for ≦52 weeks. RESULTS: 453 pts were analyzed. Median age was 73.0 years (range, 21-91). Primary tumor site was bladder in 244 (53.9%) and upper tract in 209 (46.1%). Median duration of avelumab treatment was 5.1 months (IQR, 2.3-12.0). At data cutoff, 128 pts (28.3%) remained on avelumab treatment and 184 pts (40.6%) had received next-line subsequent treatment. Prespecified adverse drug reactions (any grade) for avelumab occurred in 144 pts (31.8%) and were grade ≧3 in 35 (7.7%). Median time to treatment failure was 4.6 months (95% CI, 3.8-5.3 months). The 1-year overall survival rate was 77.9% (95% CI, 73.7-81.5). CONCLUSIONS: The final analysis of this PMS provides the largest real-world dataset of avelumab maintenance therapy for pts with advanced UC in Japan. The safety profile, tolerability, and effectiveness of avelumab maintenance therapy in this population were comparable to findings from the JAVELIN Bladder 100 trial and support the benefit of avelumab maintenance therapy in clinical practice in Japan.