近日，英国剑桥大学Stephen Duffy团队比较了补充乳腺癌成像技术对乳腺致密的妇女进行乳腺筛查的效果。2025年5月21日，《柳叶刀》杂志发表了这一成果。

目前尚不清楚哪种辅助成像技术对乳腺致密的妇女进行乳腺筛查最有益。研究组比较了短时间MRI、全自动全乳超声（ABUS）和对比增强乳房x线照相术与致密乳房和阴性乳房x线照相术的标准护理。他们报告第一轮补充成像的中期结果。

在这项英国随机对照试验中，在10个乳腺筛查点，女性（50-70岁）被分批（日间/移动筛查车）独立分配到缩短MRI， ABUS或对比增强乳房x光检查或标准护理（全场数字乳房x光检查），每个中心的可用性因方式而异。如果乳房x光检查呈阴性且乳房致密，则邀请女性参加。主要结果是检出率，定义为补充影像学检查结果为阳性的妇女在组织学上确诊为乳腺癌的百分比。分析采用网络荟萃分析，将每个部位视为荟萃分析中的一项研究，并进行了两项分析：一项分析仅使用三个主动干预组（主要分析），比较三种辅助成像技术在癌症检出率、召回率和活检率方面的差异，以及仅使用全视野数字乳房x线摄影的结果；另一个是剑桥大学的全领域数字乳房x光检查的观察数据。

从2019年10月18日至2024年3月30日，研究组招募并随机分配了9361名符合条件的女性（2318名接受简化MRI， 2240名接受ABUS， 2235名接受对比增强乳房x光检查，2568名接受标准护理）。其中，6305例完成了补充成像（缩略MRI 2130例，ABUS 2141例，增强乳房x光造影2035例），并纳入结果分析。缩位MRI检出率为17.4 (95% CI 12.2 - 23.9, n=37) / 1000次，ABUS检出率为4.2 (1.9 - 8.0,n=9) / 1000次，乳腺造影检出率为19.2 (13.7 - 26.1,n=39) / 1000次，其中缩位MRI检出率为15.0 (10.3 - 21.1,n=32) / 1000次，ABUS检出率为4.2 (1.9 - 8.0,n=9) / 1000次，乳腺造影检出率为15.7 (10.8 - 22.1,n=32) / 1000次，浸润性癌为15.7 (10.8 - 22.1,n=32) / 1000次。缩短MRI的检出率显著高于ABUS (p= 0.047)，而不显著高于乳房造影（p= 0.62）。缩短MRI组有1例外渗（每1000次检查0.5例），ABUS组无不良反应，24例碘造影剂反应（17例轻微反应[每1000次检查8.4例]，6例中度反应[每1000次检查2.9例]，1例严重反应[每1000次检查0.5例]）和3例外渗（每1000次检查1.5例外渗）。

研究结果表明，与ABUS相比，短时间MRI和增强乳房x光检查发现的浸润性癌症是ABUS的三倍，癌症的大小是ABUS的一半。这项研究表明，补充成像可以使致密乳房的妇女更早地发现癌症，但不能估计过度诊断的程度。

附：英文原文

Title: Comparison of supplemental breast cancer imaging techniques—interim results from the BRAID randomised controlled trial

Author: Fiona J Gilbert, Nicholas R Payne, Iris Allajbeu, Lim Yit, Sarah Vinnicombe, Iain Lyburn, Nisha Sharma, Will Teh, Jonathan James, Archana Seth, Tamara Suaris, Reena Aggarwal, Miaad Al-Attar, Sarah Savaridas, Antonis Antoniou, Paul Pharoah, Stephen Duffy

Issue&Volume: 2025-05-21

Abstract:

Background

It is not known which supplemental imaging technique is most beneficial for women with dense breasts attending breast screening. This study compares abbreviated MRI, automated whole breast ultrasound (ABUS), and contrast-enhanced mammography versus standard of care in women with dense breasts and a negative mammogram. We report on interim results from the first round of supplemental imaging.

Methods

In this UK randomised controlled trial, at ten breast screening sites, women (aged 50–70 years) were independently allocated by batches (day/mobile screening van) to either abbreviated MRI, ABUS, or contrast-enhanced mammography or standard of care (full-field digital mammography) varied by modality availability at each centre. Women were invited if their mammogram was negative and they had dense breasts. Primary outcome was detection rate, defined as the percentage of women with a positive result on supplemental imaging that resulted in histologically confirmed breast cancer. Analysis was by imaging received (intention to treat) using network meta-analysis, treating each site as a study in the meta-analysis, with two analyses carried out: one using only the three active intervention arms (primary analysis) that compared the three supplemental imaging techniques with respect to cancer detection, recall, and biopsy rates in addition to those resulting from full-field digital mammography alone; and one with the addition of the observational data from Cambridge on full-field digital mammography alone. This trial is closed for recruitment and is registered with ClinicalTrials.gov, NCT04097366.

Findings

From October 18, 2019, to March 30, 2024, 9361 eligible women were recruited and randomly assigned (2318 to abbreviated MRI, 2240 to ABUS, 2235 to contrast-enhanced mammography, and 2568 to standard of care). Of those, 6305 completed supplementary imaging (2130 in the abbreviated MRI, 2141 in the ABUS, and 2035 in the contrast-enhanced mammography) and were included in the outcome analysis. The cancer detection rate was 17·4 (95% CI 12·2–23·9, n=37) per 1000 examinations for abbreviated MRI, 4·2 (1·9–8·0, n=9) per 1000 examinations for ABUS, and 19·2 (13·7–26·1, n=39) per 1000 examinations for contrast-enhanced mammography, of which 15·0 (10·3–21·1, n=32) per 1000 women for abbreviated MRI, 4·2 (1·9–8·0, n=9) per 1000 examinations for ABUS, and 15·7 (10·8–22·1, n=32) per 1000 examinations for contrast-enhanced mammography were invasive cancers. The detection rates for abbreviated MRI were significantly higher than for ABUS (p=0·047) and non-significantly higher than for contrast-enhanced mammography (p=0·62). There was one case of extravasation in the abbreviated MRI arm (0·5 events per 1000 examinations), no adverse events in the ABUS arm, and 24 iodinated contrast reactions (17 minor [8·4 events per 1000 examinations], six moderate [2·9 events per 1000 examinations], and one severe [0·5 events per 1000 examinations]) and three extravasations (1·5 extravasations per 1000 examinations) in the contrast-enhanced mammography arm.

Interpretation

Abbreviated MRI and contrast-enhanced mammography detected three times as many invasive cancers compared with ABUS, with cancers being half the size. This study shows that supplemental imaging could lead to earlier detection of cancer in women with dense breasts but does not estimate the level of overdiagnosis.

DOI: 10.1016/S0140-6736(25)00582-3

Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)00582-3/abstract