Grivas Petros, Moon Helen H
University of Washington, Fred Hutch Cancer Center, Seattle, WA, USA.
Kaiser Permanente, Riverside, CA, USA.
Target Oncol. 2025 Jul 1. doi: 10.1007/s11523-025-01162-4.
Avelumab first-line maintenance is an approved treatment for cisplatin-eligible or -ineligible patients with advanced urothelial carcinoma (UC) who are progression free following first-line platinum-based chemotherapy, based on the results of the JAVELIN Bladder 100 phase 3 trial. In recent years, an increasing number of real-world studies have examined the effectiveness and safety of avelumab first-line maintenance in heterogeneous populations from different countries, expanding the clinical evidence base. In this podcast, we discuss findings from these real-world studies, which have complemented clinical trials and provided additional insights about overall effectiveness, treatment sequencing involving second-line enfortumab vedotin monotherapy or other options, and healthcare resource utilization. We also briefly discuss the evolving treatment landscape in advanced UC in addition to benefits and limitations of real-world studies in general. Overall, across multiple studies involving more than 3000 patients worldwide, real-world outcomes with avelumab first-line maintenance treatment have been consistent with findings from the JAVELIN Bladder 100 trial, confirming the clinical benefits of this treatment approach for patients with advanced UC who are encountered in day-to-day practice.
基于JAVELIN Bladder 100 3期试验的结果，阿维鲁单抗一线维持治疗是一种已获批准的治疗方法，适用于一线铂类化疗后无进展的晚期尿路上皮癌（UC）患者，无论其是否符合顺铂治疗条件。近年来，越来越多的真实世界研究探讨了阿维鲁单抗一线维持治疗在来自不同国家的异质性人群中的有效性和安全性，扩大了临床证据基础。在本期播客中，我们将讨论这些真实世界研究的结果，这些结果补充了临床试验，并提供了关于总体有效性、涉及二线恩杂鲁胺单药治疗或其他选择的治疗顺序以及医疗资源利用的更多见解。我们还将简要讨论晚期UC不断变化的治疗格局以及真实世界研究的一般益处和局限性。总体而言，在全球范围内涉及3000多名患者的多项研究中，阿维鲁单抗一线维持治疗的真实世界结果与JAVELIN Bladder 100试验的结果一致，证实了这种治疗方法对日常临床中遇到的晚期UC患者的临床益处。
