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ATLANTIS：在晚期或转移性尿路上皮癌患者中，化疗后进行维持靶向治疗的随机多臂 II 期生物标志物导向伞式筛选试验。

ATLANTIS: a randomised multi-arm phase II biomarker-directed umbrella screening trial of maintenance targeted therapy after chemotherapy in patients with advanced or metastatic urothelial cancer.

机构信息

Beatson West of Scotland Cancer Centre, 1053 Great Western Road, Glasgow, G12 0YN, UK.

Institute of Cancer Sciences, Switchback Road, Bearsden, Glasgow, G61 1QH, UK.

出版信息

Trials. 2020 Apr 19;21(1):344. doi: 10.1186/s13063-020-04283-5.

DOI:10.1186/s13063-020-04283-5
PMID:32306987
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7168999/
Abstract

BACKGROUND

Metastatic urothelial cancer (UC) is the eighth most common cause of cancer death in the UK. Standard first-line treatment, for most patients, is cytotoxic chemotherapy. Although UC is initially sensitive to chemotherapy, relapse is almost inevitable and outcomes are poor; median overall survival is 8 months. Therefore, there is an urgent need for novel therapies to improve outcomes for this patient group.

METHODS

ATLANTIS is a randomised phase II umbrella-design screening trial of maintenance therapy in biomarker-defined subgroups of patients with advanced UC. The primary end point is progression-free survival, and the study involves over 30 UK cancer centres.

DISCUSSION

ATLANTIS is the first study in the UK to employ a precision-medicine approach to patients with UC for maintenance treatment. Agents with a positive efficacy signal will proceed to randomised phase III trials to confirm the activity of novel, biologically stratified therapies in UC.

REGISTRATION

ATLANTIS trial EudraCT number 2015-003249-25. ISRCTN25859465.

摘要

背景

转移性尿路上皮癌（UC）是英国第八大常见的癌症死因。对于大多数患者来说，标准的一线治疗是细胞毒性化疗。尽管 UC 最初对化疗敏感，但几乎不可避免地会复发，且预后较差；中位总生存期为 8 个月。因此，迫切需要新的疗法来改善这一患者群体的预后。

方法

ATLANTIS 是一项在生物标志物定义的晚期 UC 患者亚组中进行维持治疗的随机 II 期伞式设计筛选试验。主要终点是无进展生存期，该研究涉及 30 多家英国癌症中心。

讨论

ATLANTIS 是英国第一项针对 UC 维持治疗采用精准医学方法的研究。具有阳性疗效信号的药物将进入随机 III 期试验，以确认新型生物分层疗法在 UC 中的活性。

注册

ATLANTIS 试验 EudraCT 编号 2015-003249-25。ISRCTN25859465。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/54d9/7168999/4eeba783fce4/13063_2020_4283_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/54d9/7168999/54be8622e985/13063_2020_4283_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/54d9/7168999/4eeba783fce4/13063_2020_4283_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/54d9/7168999/54be8622e985/13063_2020_4283_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/54d9/7168999/4eeba783fce4/13063_2020_4283_Fig2_HTML.jpg

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