Maintenance Therapy With Avelumab for Patients With Metastatic Urothelial Carcinoma: A Real-World, Ambispective RAVE-Bladder Study

IF 3.1 2区医学 Q2 ONCOLOGY Cancer Medicine Pub Date : 2025-02-14 DOI:10.1002/cam4.70636

Ilya Tsimafeyeu, Yana Gridneva, Alexander Sultanbaev, Yulia Anzhiganova, Mark Gluzman, Anastasia Mochalova, Alexey Shkurat, Edgar Israelyan, Elvira Parsadanova, Yulia Murzina, Aleksei Ivanov, Alexey Kalpinskiy, Olesia Stativko, Vladislav Petkau, Elena Karabina, Artyom Kеln, Natalya Tovbik, Sufia Safina, Maria Turganova, Evgeny Kopyltsov, Varvara Bragina, Olga Novikova, Andrei Lebedinets, Vladislav Vodolazskiy, Alexey Rumyantsev, Ruslan Zukov, Ilya Pokataev, Rashida Orlova, Maria Volkova

{"title":"Maintenance Therapy With Avelumab for Patients With Metastatic Urothelial Carcinoma: A Real-World, Ambispective RAVE-Bladder Study","authors":"Ilya Tsimafeyeu, Yana Gridneva, Alexander Sultanbaev, Yulia Anzhiganova, Mark Gluzman, Anastasia Mochalova, Alexey Shkurat, Edgar Israelyan, Elvira Parsadanova, Yulia Murzina, Aleksei Ivanov, Alexey Kalpinskiy, Olesia Stativko, Vladislav Petkau, Elena Karabina, Artyom Kеln, Natalya Tovbik, Sufia Safina, Maria Turganova, Evgeny Kopyltsov, Varvara Bragina, Olga Novikova, Andrei Lebedinets, Vladislav Vodolazskiy, Alexey Rumyantsev, Ruslan Zukov, Ilya Pokataev, Rashida Orlova, Maria Volkova","doi":"10.1002/cam4.70636","DOIUrl":null,"url":null,"abstract":"<div>\n \n \n <section>\n \n <h3> Background</h3>\n \n <p>This ambispective study was designed to assess the efficacy and safety of avelumab maintenance in a real-world population of patients with metastatic urothelial cancer (UC).</p>\n </section>\n \n <section>\n \n <h3> Methods</h3>\n \n <p>Patients with metastatic UC and measurable disease that had not progressed following first-line platinum-based chemotherapy were treated with maintenance avelumab (800 mg administered every 2 weeks). The primary endpoint was overall survival (OS).</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>A total of 110 patients were enrolled. The majority of patients were male (81%), with a median age of 65 years (range, 36–84). The median OS was not reached, with a 1-year OS rate of 78.7%. The median PFS was 9.5 months (95% CI, 7.8–11.2 months). The ORR to first-line chemotherapy was 48.2%, and an additional 34.6% of patients responded to avelumab therapy (16 complete and 22 partial responses). Grade 3 adverse events during avelumab therapy were experienced by 11.8% of patients.</p>\n </section>\n \n <section>\n \n <h3> Conclusions</h3>\n \n <p>These findings demonstrate similar efficacy and safety of avelumab in a real-world setting when compared to data from pivotal study.</p>\n \n <p><b>Trial Registration:</b> KCRB registry number: RAVE-Bladder</p>\n </section>\n </div>","PeriodicalId":139,"journal":{"name":"Cancer Medicine","volume":"14 4","pages":""},"PeriodicalIF":3.1000,"publicationDate":"2025-02-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/cam4.70636","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Cancer Medicine","FirstCategoryId":"3","ListUrlMain":"https://onlinelibrary.wiley.com/doi/10.1002/cam4.70636","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"ONCOLOGY","Score":null,"Total":0}

引用次数: 0

Abstract

Background

This ambispective study was designed to assess the efficacy and safety of avelumab maintenance in a real-world population of patients with metastatic urothelial cancer (UC).

Methods

Patients with metastatic UC and measurable disease that had not progressed following first-line platinum-based chemotherapy were treated with maintenance avelumab (800 mg administered every 2 weeks). The primary endpoint was overall survival (OS).

Results

A total of 110 patients were enrolled. The majority of patients were male (81%), with a median age of 65 years (range, 36–84). The median OS was not reached, with a 1-year OS rate of 78.7%. The median PFS was 9.5 months (95% CI, 7.8–11.2 months). The ORR to first-line chemotherapy was 48.2%, and an additional 34.6% of patients responded to avelumab therapy (16 complete and 22 partial responses). Grade 3 adverse events during avelumab therapy were experienced by 11.8% of patients.

Conclusions

These findings demonstrate similar efficacy and safety of avelumab in a real-world setting when compared to data from pivotal study.

Trial Registration: KCRB registry number: RAVE-Bladder

Abstract Image

查看原文

微信好友朋友圈 QQ好友复制链接

本刊更多论文

用Avelumab治疗转移性尿路上皮癌患者的维持治疗：一项真实世界、双侧视野的rave -膀胱研究

本双视角研究旨在评估在现实世界中转移性尿路上皮癌（UC）患者中维持avelumab治疗的有效性和安全性。方法转移性UC和可测量疾病患者在一线铂基化疗后未进展，使用维持性avelumab治疗（每2周给药800 mg）。主要终点是总生存期（OS）。结果共纳入110例患者。大多数患者为男性（81%），中位年龄65岁（范围36-84岁）。中位OS未达到，1年OS率为78.7%。中位PFS为9.5个月（95% CI, 7.8-11.2个月）。一线化疗的ORR为48.2%，另外34.6%的患者对avelumab治疗有反应（16例完全缓解，22例部分缓解）。11.8%的患者在avelumab治疗期间发生了3级不良事件。这些研究结果表明，与枢纽研究的数据相比，avelumab在现实环境中的疗效和安全性相似。试验注册：九铁局注册编号：rave -膀胱

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文去求助

来源期刊

Cancer Medicine ONCOLOGY-

CiteScore

5.50

自引率

2.50%

发文量

907

审稿时长

19 weeks

期刊介绍： Cancer Medicine is a peer-reviewed, open access, interdisciplinary journal providing rapid publication of research from global biomedical researchers across the cancer sciences. The journal will consider submissions from all oncologic specialties, including, but not limited to, the following areas: Clinical Cancer Research Translational research ∙ clinical trials ∙ chemotherapy ∙ radiation therapy ∙ surgical therapy ∙ clinical observations ∙ clinical guidelines ∙ genetic consultation ∙ ethical considerations Cancer Biology: Molecular biology ∙ cellular biology ∙ molecular genetics ∙ genomics ∙ immunology ∙ epigenetics ∙ metabolic studies ∙ proteomics ∙ cytopathology ∙ carcinogenesis ∙ drug discovery and delivery. Cancer Prevention: Behavioral science ∙ psychosocial studies ∙ screening ∙ nutrition ∙ epidemiology and prevention ∙ community outreach. Bioinformatics: Gene expressions profiles ∙ gene regulation networks ∙ genome bioinformatics ∙ pathwayanalysis ∙ prognostic biomarkers. Cancer Medicine publishes original research articles, systematic reviews, meta-analyses, and research methods papers, along with invited editorials and commentaries. Original research papers must report well-conducted research with conclusions supported by the data presented in the paper.