Minato Akinori, Mizushima Yui, Sugita Yoshihiro, Takaba Tomohisa, Matsukawa Takuo, Jojima Kazumasa, Kimuro Rieko, Higashijima Katsuyoshi, Nagata Yujiro, Tomisaki Ikko, Kashiwagi Eiji, Fujimoto Naohiro
Department of Urology, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan;
Department of Urology, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan.
In Vivo. 2025 Jul-Aug;39(4):2123-2132. doi: 10.21873/invivo.14008.
BACKGROUND/AIM: Avelumab maintenance therapy following first-line platinum-based chemotherapy is reportedly effective against advanced urothelial carcinoma (UC). However, this therapy, including its survival outcome, remains poorly investigated in a real-world setting in Japan.
This study retrospectively evaluated the clinical outcomes of avelumab maintenance therapy in patients with advanced lower- and upper-tract UC after no progression on first-line platinum-based chemotherapy at our institution between May 2021 and August 2024. Efficacy, survival, and safety analyses were performed starting from avelumab introduction.
In total, 22 patients were enrolled, of which 7 (31.8%) were female, 9 (40.9%) had performance status score ≥1, and 9 (40.9%) had upper-tract UC. The objective response and disease control rates were 4.5% and 50.0%, respectively. While receiving avelumab, no patients experienced immune-related adverse events (irAEs) of grade ≥3. The median progression-free survival (PFS) and overall survival were 3.3 and 22.2 months, respectively. When comparing median PFS of patients with a complete or partial response to prior platinum-based chemotherapy to the patients with stable disease, the first had significantly longer PFS (4.0 months, 95% confidence interval=2.3-10.1 . 2.2 months, 95% confidence interval=0.9-3.9; =0.034). The PFS did not significantly differ between patients with and without irAEs or infusion-related reaction.
Avelumab maintenance therapy demonstrated favorable survival outcomes and tolerability in patients with advanced UC in daily practice.
背景/目的：据报道，一线铂类化疗后的阿维鲁单抗维持治疗对晚期尿路上皮癌（UC）有效。然而，在日本的实际临床环境中，这种治疗方法，包括其生存结果，仍未得到充分研究。
本研究回顾性评估了2021年5月至2024年8月期间，在我院接受一线铂类化疗后无进展的晚期上尿路和下尿路UC患者接受阿维鲁单抗维持治疗的临床结果。从开始使用阿维鲁单抗起进行疗效、生存和安全性分析。
总共纳入22例患者，其中7例（31.8%）为女性，9例（40.9%）体能状态评分≥1，9例（40.9%）患有上尿路UC。客观缓解率和疾病控制率分别为4.5%和50.0%。在接受阿维鲁单抗治疗期间，没有患者发生≥3级免疫相关不良事件（irAE）。中位无进展生存期（PFS）和总生存期分别为3.3个月和22.2个月。将先前铂类化疗后完全或部分缓解的患者的中位PFS与疾病稳定的患者进行比较，前者的PFS显著更长（4.0个月，95%置信区间=2.3-10.1；2.2个月，95%置信区间=0.9-3.9；P=0.034）。有irAE或输液相关反应的患者与无此类反应的患者之间的PFS无显著差异。
在日常临床实践中，阿维鲁单抗维持治疗在晚期UC患者中显示出良好的生存结果和耐受性。
