Neeter Lidewij M F H, Nelemans Patricia J, Raat H P J, Frotscher Caroline, Duvivier Katya M, Essers Brigitte A B, Smidt Marjolein L, Wildberger Joachim E, Lobbes Marc B I
Maastricht University Medical Center, Department of Radiology and Nuclear Medicine, P.O. Box 5800, 6202AZ, Maastricht, the Netherlands.
GROW School for Oncology and Reproduction, Maastricht University, P.O. Box 616, 6200MD, Maastricht, the Netherlands.
Lancet Reg Health Eur. 2024 Jul 3;44:100987. doi: 10.1016/j.lanepe.2024.100987. eCollection 2024 Sep.
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.
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.
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.
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.
ZonMw (grant number 843001801) and GE Healthcare.
因乳腺癌筛查被召回的女性在医院接受常规乳腺成像的筛查后检查。RACER试验旨在研究以对比增强乳腺X线摄影（CEM）作为主要成像手段而非传统成像，是否能在被召回的女性中实现更准确、高效的诊断检查。
在这项随机对照试验（注册号为NL6413/NTR6589）中，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至CEM组或传统成像组，作为主要检查工具。预先确定的患者因素包括召回原因、BI-RADS评分和研究中心。主要结局指标为敏感性和特异性。次要结局指标为需要补充检查的女性比例以及直至确诊的天数。
2018年4月至2021年9月期间，529名从荷兰筛查项目中被召回的患者被随机分组，265名接受传统成像，264名接受CEM。对照组中有3名患者因违反方案而被排除在分析之外。在整个检查结束后，干预组的敏感性为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）。仅基于初次全视野数字乳腺X线摄影/数字乳腺断层合成或CEM，干预组中有27.7%（73/264）达成最终诊断，对照组为1.1%（3/262）。对照组补充成像的频率显著更高（p < 0.0001）。达成最终诊断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检测到13个隐匿性恶性病变，而使用传统成像检测到3个。未发生严重不良事件。
CEM在被召回女性检查中的诊断准确性与传统成像相当。然而，以CEM作为主要成像的检查是一条更有效的途径。
荷兰卫生与福利研究所（资助编号843001801）和通用电气医疗集团。
