Survival and Safety Outcomes of Avelumab Maintenance Therapy for Advanced Urothelial Carcinoma from a Single-Center Experience.

IF 1.8 4区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

In vivo Pub Date : 2025-07-01 DOI:10.21873/invivo.14008

Akinori Minato, Yui Mizushima, Yoshihiro Sugita, Tomohisa Takaba, Takuo Matsukawa, Kazumasa Jojima, Rieko Kimuro, Katsuyoshi Higashijima, Yujiro Nagata, Ikko Tomisaki, Eiji Kashiwagi, Naohiro Fujimoto

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引用次数: 0

Abstract

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.

Patients and methods: 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.

Results: 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 vs. 2.2 months, 95% confidence interval=0.9-3.9; p=0.034). The PFS did not significantly differ between patients with and without irAEs or infusion-related reaction.

Conclusion: Avelumab maintenance therapy demonstrated favorable survival outcomes and tolerability in patients with advanced UC in daily practice.

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单中心研究：Avelumab维持治疗晚期尿路上皮癌的生存和安全性

背景/目的：据报道，一线铂基化疗后的Avelumab维持治疗对晚期尿路上皮癌（UC）有效。然而，这种疗法，包括其生存结果，在日本的现实环境中仍未得到充分的研究。患者和方法：本研究回顾性评估了我院2021年5月至2024年8月一线铂类化疗无进展的晚期下尿路和上尿路UC患者使用avelumab维持治疗的临床结果。从引入avelumab开始进行疗效、生存和安全性分析。结果：共纳入22例患者，其中7例（31.8%）为女性，9例（40.9%）表现状态评分≥1,9例（40.9%）为上尿路UC。客观有效率4.5%，疾病控制率50.0%。在接受avelumab治疗时，没有患者出现≥3级的免疫相关不良事件（irAEs）。中位无进展生存期（PFS）和总生存期分别为3.3和22.2个月。当比较先前铂类化疗完全或部分缓解的患者与疾病稳定的患者的中位PFS时，前者的PFS明显更长(4.0个月，95%可信区间=2.3-10.1 vs. 2.2个月，95%可信区间=0.9-3.9；p = 0.034)。在有和没有irAEs或输注相关反应的患者之间，PFS没有显著差异。结论：在日常实践中，Avelumab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。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

In vivo 医学-医学：研究与实验

CiteScore

4.20

自引率

4.30%

发文量

330

审稿时长

3-8 weeks

期刊介绍： IN VIVO is an international peer-reviewed journal designed to bring together original high quality works and reviews on experimental and clinical biomedical research within the frames of physiology, pathology and disease management. The topics of IN VIVO include: 1. Experimental development and application of new diagnostic and therapeutic procedures; 2. Pharmacological and toxicological evaluation of new drugs, drug combinations and drug delivery systems; 3. Clinical trials; 4. Development and characterization of models of biomedical research; 5. Cancer diagnosis and treatment; 6. Immunotherapy and vaccines; 7. Radiotherapy, Imaging; 8. Tissue engineering, Regenerative medicine; 9. Carcinogenesis.