Avelumab First-Line Maintenance for Locally Advanced or Metastatic Urothelial Carcinoma: Results From the Real-World US PATRIOT-II Study

IF 2.3 3区医学 Q3 ONCOLOGY

Clinical genitourinary cancer Pub Date : 2024-10-17 DOI:10.1016/j.clgc.2024.102238

Petros Grivas , Pedro Barata , Helen Moon , Shilpa Gupta , Thomas Hutson , Cora N. Sternberg , Jason R. Brown , Vaidehi Dave , Chad Downey , Alicia C. Shillington , Howard M. Katzenstein , Melissa Kirker , Sarah Hanson , Frank X. Liu , Valerie Morris , Abhijeet Bhanegaonkar , Guru P. Sonpavde

{"title":"Avelumab First-Line Maintenance for Locally Advanced or Metastatic Urothelial Carcinoma: Results From the Real-World US PATRIOT-II Study","authors":"Petros Grivas , Pedro Barata , Helen Moon , Shilpa Gupta , Thomas Hutson , Cora N. Sternberg , Jason R. Brown , Vaidehi Dave , Chad Downey , Alicia C. Shillington , Howard M. Katzenstein , Melissa Kirker , Sarah Hanson , Frank X. Liu , Valerie Morris , Abhijeet Bhanegaonkar , Guru P. Sonpavde","doi":"10.1016/j.clgc.2024.102238","DOIUrl":null,"url":null,"abstract":"<div><h3>Introduction</h3><div>In JAVELIN Bladder 100, avelumab first-line maintenance (1LM) improved overall survival (OS) and progression-free survival (PFS) in patients with locally advanced/metastatic urothelial carcinoma (la/mUC) without progression following 1L platinum-based chemotherapy (PBC) versus best supportive care. PATRIOT-II describes real-world outcomes with avelumab 1LM.</div></div><div><h3>Patients and Methods</h3><div>This observational, retrospective study of avelumab 1LM in US community/academic centers used medical record data collected from avelumab initiation for ≥12 months to assess survival, safety, and healthcare resource utilization; analyses are descriptive.</div></div><div><h3>Results</h3><div>The study included 160 patients from 37 centers (median age, 70 years; 77% male). Avelumab 1LM was initiated at a median of 4 weeks (IQR 3-6) after PBC completion. Median follow-up from avelumab 1LM was 16 months (IQR 11-21). At study end, 19.4% of patients continued avelumab; 73.7% had discontinued due to progression, adverse events (AEs), or performance status deterioration. Median PFS and OS from avelumab initiation were 5.4 months (95% CI, 3.8-6.9) and 24.4 months (95% CI, 20.4-28.4), respectively. Grade ≥3 treatment-related AEs (TRAEs) occurred in 15 patients (9.4%); 35 (21.9%) had any-grade immune-related AEs, and 23 (14.3%) received high-dose systemic corticosteroids for AEs. Forty-four patients (27.5%) were hospitalized during the avelumab treatment period, of whom 13 (8.1%) were hospitalized due to TRAEs. Limitations of this study include a small sample size, potential selection bias, and missing/unknown data.</div></div><div><h3>Conclusion</h3><div>These results align with the JAVELIN Bladder 100 clinical trial and other real-world studies, supporting avelumab 1LM use in patients with la/mUC without progression following 1L PBC.</div></div>","PeriodicalId":10380,"journal":{"name":"Clinical genitourinary cancer","volume":"22 6","pages":"Article 102238"},"PeriodicalIF":2.3000,"publicationDate":"2024-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical genitourinary cancer","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1558767324002088","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"ONCOLOGY","Score":null,"Total":0}

引用次数: 0

Abstract

Introduction

In JAVELIN Bladder 100, avelumab first-line maintenance (1LM) improved overall survival (OS) and progression-free survival (PFS) in patients with locally advanced/metastatic urothelial carcinoma (la/mUC) without progression following 1L platinum-based chemotherapy (PBC) versus best supportive care. PATRIOT-II describes real-world outcomes with avelumab 1LM.

Patients and Methods

This observational, retrospective study of avelumab 1LM in US community/academic centers used medical record data collected from avelumab initiation for ≥12 months to assess survival, safety, and healthcare resource utilization; analyses are descriptive.

Results

The study included 160 patients from 37 centers (median age, 70 years; 77% male). Avelumab 1LM was initiated at a median of 4 weeks (IQR 3-6) after PBC completion. Median follow-up from avelumab 1LM was 16 months (IQR 11-21). At study end, 19.4% of patients continued avelumab; 73.7% had discontinued due to progression, adverse events (AEs), or performance status deterioration. Median PFS and OS from avelumab initiation were 5.4 months (95% CI, 3.8-6.9) and 24.4 months (95% CI, 20.4-28.4), respectively. Grade ≥3 treatment-related AEs (TRAEs) occurred in 15 patients (9.4%); 35 (21.9%) had any-grade immune-related AEs, and 23 (14.3%) received high-dose systemic corticosteroids for AEs. Forty-four patients (27.5%) were hospitalized during the avelumab treatment period, of whom 13 (8.1%) were hospitalized due to TRAEs. Limitations of this study include a small sample size, potential selection bias, and missing/unknown data.

Conclusion

These results align with the JAVELIN Bladder 100 clinical trial and other real-world studies, supporting avelumab 1LM use in patients with la/mUC without progression following 1L PBC.

查看原文本刊更多论文

阿维单抗一线维持治疗局部晚期或转移性尿路上皮癌：美国 PATRIOT-II 真实世界研究结果。

简介在JAVELIN Bladder 100研究中，阿维列单抗一线维持治疗（1LM）与最佳支持治疗相比，提高了局部晚期/转移性尿路上皮癌（la/mUC）患者的总生存期（OS）和无进展生存期（PFS）。PATRIOT-II描述了阿维列单抗1LM的实际疗效：这项在美国社区/学术中心进行的阿维列单抗1LM观察性、回顾性研究使用了从阿维列单抗开始治疗≥12个月时收集的病历数据，以评估生存率、安全性和医疗资源利用率；分析为描述性分析：研究纳入了来自 37 个中心的 160 名患者（中位年龄 70 岁；77% 为男性）。阿维列单抗 1LM 在 PBC 结束后中位 4 周（IQR 3-6）时启动。阿维列单抗1LM的中位随访时间为16个月（IQR为11-21）。研究结束时，19.4%的患者继续使用阿维单抗；73.7%的患者因病情进展、不良事件（AE）或表现状态恶化而停药。从开始使用阿维鲁单抗起，中位PFS和OS分别为5.4个月（95% CI，3.8-6.9）和24.4个月（95% CI，20.4-28.4）。15名患者（9.4%）出现了≥3级治疗相关AEs（TRAEs）；35名患者（21.9%）出现了任何级别的免疫相关AEs，23名患者（14.3%）因AEs接受了大剂量全身皮质类固醇治疗。44名患者（27.5%）在阿维鲁单抗治疗期间住院，其中13名患者（8.1%）因TRAE住院。本研究的局限性包括样本量较小、潜在的选择偏倚以及数据缺失/未知：这些结果与JAVELIN Bladder 100临床试验及其他实际研究结果一致，支持阿维列单抗1LM用于1L PBC后无进展的la/mUC患者。

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分钟内获得全文求助全文

来源期刊

Clinical genitourinary cancer 医学-泌尿学与肾脏学

CiteScore

5.20

自引率

6.20%

发文量

201

审稿时长

54 days

期刊介绍： Clinical Genitourinary Cancer is a peer-reviewed journal that publishes original articles describing various aspects of clinical and translational research in genitourinary cancers. Clinical Genitourinary Cancer is devoted to articles on detection, diagnosis, prevention, and treatment of genitourinary cancers. The main emphasis is on recent scientific developments in all areas related to genitourinary malignancies. Specific areas of interest include clinical research and mechanistic approaches; drug sensitivity and resistance; gene and antisense therapy; pathology, markers, and prognostic indicators; chemoprevention strategies; multimodality therapy; and integration of various approaches.