Lidewij M.F.H. Neeter , Patricia J. Nelemans , H.P.J. Raat Frank , Caroline Frotscher , Katya M. Duvivier , Brigitte A.B. Essers , Marjolein L. Smidt , Joachim E. Wildberger , Marc B.I. Lobbes
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Predefined patients’ factors were reason for recall, BI-RADS score, and study centre. Primary outcomes were sensitivity and specificity. Secondary outcomes were the proportion of women needing supplemental examinations, and number of days until diagnosis.</p></div><div><h3>Findings</h3><p>Between April, 2018, and September, 2021, 529 patients recalled from the Dutch screening program were randomised, 265 to conventional imaging and 264 to CEM. Three patients in the control arm had to be excluded from analysis due to a protocol breach. After the entire work-up, sensitivity was 98.0% (95% CI; 92.2–99.7%) in the intervention arm and 97.7% (91.8–99.6%) in the control arm (p = 1.0), and specificity was 75.6% (72.5–76.6%) and 75.4% (72.5–76.4%, p = 1.0), respectively. Based on only primary full-field digital mammography/digital breast tomosynthesis or CEM, final diagnosis was reached in 27.7% (73/264) in the intervention arm and 1.1% (3/262) in the control arm. 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引用次数: 0
摘要
背景从乳腺癌筛查中被召回的妇女在医院接受常规乳腺成像的筛查后工作。这项随机对照试验(注册号为 NL6413/NTR6589)在两家综合医院和两家学术医院采用确定性最小化方法将参与者分配到造影剂增强乳腺造影术(CEM)或传统造影术作为主要检查手段。预先确定的患者因素包括召回原因、BI-RADS 评分和研究中心。主要结果是灵敏度和特异性。结果2018年4月至2021年9月期间,从荷兰筛查计划中召回的529名患者被随机分配,其中265人接受传统成像检查,264人接受CEM检查。对照组中有三名患者因违反协议而被排除在分析之外。整个检查过程结束后,干预组的灵敏度为 98.0% (95% CI; 92.2-99.7%),对照组为 97.7% (91.8-99.6%)(p = 1.0),特异性分别为 75.6% (72.5-76.6%) 和 75.4% (72.5-76.4%, p = 1.0)。仅根据初次全视野数字乳腺 X 光摄影/数字乳腺断层扫描或 CEM,干预组中有 27.7%(73/264)的患者获得了最终诊断,对照组中只有 1.1%(3/262)的患者获得了最终诊断。对照组补充成像的频率明显更高(p < 0.0001)。最终确诊所需的中位时间相当:1天(对照组:IQR 0-4;干预组:IQR 0-3)。使用 CEM 发现了 13 个恶性隐匿病灶,而使用传统成像发现了 3 个。没有发生严重的不良事件。解释:CEM 在对召回的妇女进行检查时的诊断准确性与传统成像技术相当。然而,以 CEM 作为主要成像进行检查是一种更有效的途径。资助ZonMw(资助编号 843001801)和 GE Healthcare。
Contrast-enhanced mammography versus conventional imaging in women recalled from breast cancer screening (RACER trial): a multicentre, open-label, randomised controlled clinical trial
Background
Women recalled from breast cancer screening receive post-screening work-up in the hospital with conventional breast imaging. The RACER trial aimed to study whether contrast-enhanced mammography (CEM) as primary imaging instead of conventional imaging resulted in more accurate and efficient diagnostic work-up in recalled women.
Methods
In this randomised, controlled trial (registered under NL6413/NTR6589) participants were allocated using deterministic minimisation to CEM or conventional imaging as a primary work-up tool in two general and two academic hospitals. Predefined patients’ factors were reason for recall, BI-RADS score, and study centre. Primary outcomes were sensitivity and specificity. Secondary outcomes were the proportion of women needing supplemental examinations, and number of days until diagnosis.
Findings
Between April, 2018, and September, 2021, 529 patients recalled from the Dutch screening program were randomised, 265 to conventional imaging and 264 to CEM. Three patients in the control arm had to be excluded from analysis due to a protocol breach. After the entire work-up, sensitivity was 98.0% (95% CI; 92.2–99.7%) in the intervention arm and 97.7% (91.8–99.6%) in the control arm (p = 1.0), and specificity was 75.6% (72.5–76.6%) and 75.4% (72.5–76.4%, p = 1.0), respectively. Based on only primary full-field digital mammography/digital breast tomosynthesis or CEM, final diagnosis was reached in 27.7% (73/264) in the intervention arm and 1.1% (3/262) in the control arm. The frequency of supplemental imaging was significantly higher in the control arm (p < 0.0001). Median time needed to reach final diagnosis was comparable: 1 day (control arm: IQR 0–4; intervention arm: IQR 0–3). Thirteen malignant occult lesions were detected using CEM, versus three using conventional imaging. No serious adverse events occurred.
Interpretation
Diagnostic accuracy of CEM in the work-up of recalled women is comparable with conventional imaging. However, work-up with CEM as primary imaging is a more efficient pathway.
期刊介绍:
The Lancet Regional Health – Europe, a gold open access journal, is part of The Lancet's global effort to promote healthcare quality and accessibility worldwide. It focuses on advancing clinical practice and health policy in the European region to enhance health outcomes. The journal publishes high-quality original research advocating changes in clinical practice and health policy. It also includes reviews, commentaries, and opinion pieces on regional health topics, such as infection and disease prevention, healthy aging, and reducing health disparities.