Feasibility of a prospective, randomised, open-label, international multicentre, phase III, non-inferiority trial to assess the safety of active surveillance for low risk ductal carcinoma in situ - The LORD study
Feasibility of a prospective, randomised, open-label, international multicentre, phase III, non-inferiority trial to assess the safety of active surveillance for low risk ductal carcinoma in situ - The LORD study
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DOI：
10.1016/j.ejca.2015.05.008
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发表时间：
2015-08-01
影响因子：
8.4
通讯作者：
Wesseling, Jelle
中科院分区：
文献类型：
--
作者：
Elshof, Lotte E.;Tryfonidis, Konstantinos;Wesseling, Jelle
背景：目前关于筛查发现的导管原位癌(DCIS)过度诊断和过度治疗的争论迫切需要进行前瞻性研究来解决这一问题。相当数量的DCIS病变永远不会对健康构成危害，特别是当它涉及非到缓慢生长的低级别DCIS时。LORD研究旨在评估对低风险DCI女性进行主动监测的安全性。设计：这是一项由荷兰乳腺癌研究小组(Boog 2014-04)和欧洲癌症研究与治疗组织(EORTC-BCG 1401)领导的随机、国际多中心、开放标签、第三阶段非自卑试验。在1240名年龄在45岁的无症状、筛查发现的纯低度DCI患者中，标准治疗将与主动监测进行比较，这些患者仅基于微钙化的真空辅助活组织检查。这两个研究组都将接受为期10年的年度数字乳房X光检查。主要终点是10年同侧浸润性乳腺癌的无瘤百分率。次要终点包括患者报告的结果、随访期间的诊断性活检率、同侧乳房切除率和转化性研究。可行性：为了探索LOLD研究的兴趣和可行性，我们在EORTC和Boog中心进行了一项调查。绝大多数EORTC和Boog反应中心都表示有兴趣参加主研究。拟议的研究设计几乎得到了所有中心的认可。(C)2015年提交人。爱思唯尔有限公司出版。
Background: The current debate on overdiagnosis and overtreatment of screen-detected ductal carcinoma in situ (DCIS) urges the need for prospective studies to address this issue. A substantial number of DCIS lesions will never form a health hazard, particularly if it concerns non-to slow-growing low-grade DCIS. The LORD study aims to evaluate the safety of active surveillance in women with low-risk DCIS.Design: This is a randomised, international multicentre, open-label, phase III non-inferiority trial, led by the Dutch Breast Cancer Research Group (BOOG 2014-04) and the European Organization for Research and Treatment of Cancer (EORTC-BCG 1401). Standard treatment will be compared to active surveillance in 1240 women aged P45 years with asymptomatic, screen-detected, pure low-grade DCIS based on vacuum-assisted biopsies of microcalcifications only. Both study arms will be monitored with annual digital mammography for a period of 10 years. The primary end-point is 10-year ipsilateral invasive breast cancer free percentage. Secondary end-points include patient reported outcomes, diagnostic biopsy rate during follow-up, ipsilateral mastectomy rate and translational research.Feasibility: To explore interest in and feasibility of the LORD study we conducted a survey among EORTC and BOOG centres. A vast majority of EORTC and BOOG responding centres expressed interest in participation in the LORD study. The proposed study design is endorsed by nearly all centres. (C) 2015 The Authors. Published by Elsevier Ltd.