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 Evaluation of time to treatment (tx) failure (TTF) with avelumab first-line maintenance (1LM) in advanced urothelial carcinoma (UC) in Japan: JAVEMACS-D study
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Kobayashi Takashi, Kitamura Hiroshi, Furukawa Yuka, Kambe Anzu, Shono Michihiro, Ito Takayuki, Kikuchi Eiji
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 [Object] Avelumab maintenance tx is approved in Japan for curatively unresectable UC not progressed after platinum-based chemotherapy (PBC). We report data from the JAVEMACS-D study of avelumab 1LM using a large claims database in Japan (Medical Data Vision).
[Methods] JAVEMACS-D is a longitudinal, observational, retrospective study of patients (pts) with advanced UC who started avelumab 1LM between Feb 2021 and Apr 2023. TTF for any reason with avelumab or second-line (2L) tx, and TTF from start of avelumab to end of 2L tx (TTF2), were analyzed.
[Results] The study included 773 pts. Median observation period from start of avelumab was 14.0 mo. Median age was 74 y (IQR, 69-79); 576 pts (74.5%) were male. Primary tumor location was bladder in 463 (59.9%) and renal pelvis/ureter in 330 (42.7%). 1L PBC was gemcitabine (G)+cisplatin (C) in 474 (61.3%) and G+carboplatin (Ca) in 281 (36.4%). Median time from start of PBC to start of avelumab was 22.3 wk (IQR, 17.0-33.7). At data cutoff (Oct 2023), 394 pts (51.0%) received 2L tx, including enfortumab vedotin (EV) in 185 (47.0%) and G+C/Ca in 122 (31.0%). Median TTF (95% CI) with avelumab was 4.5 mo (3.8-5.2). Median TTF with 2L tx was 4.0 mo (3.3-4.7) overall, 7.0 mo (5.9-8.2) with 2L EV, and 2.8 mo (1.7-3.1) with 2L G+C/Ca. Median TTF2 from start of avelumab was 13.7 mo (11.9-15.7) with 2L EV and 6.4 mo (5.9-7.3) with 2L G+C/Ca.
[Conclusions] In JAVEMACS-D, 2L EV was more common than 2L PBC after avelumab 1LM even though pts were not resistant to PBC. In cases of progression after avelumab, 2L EV may extend tx duration vs 2L PBC.