Lancet Oncol：综合2D和3D钼靶筛查乳腺癌更具优势

采用3D乳房断层X线摄相或许能克服传统2D钼靶检查的不足，在发现乳腺癌病灶上更具优势。来自意大利Azienda省卫生服务公司的Stefano Ciatto等为了比较2D和3D钼靶检查在乳腺癌筛查方面的效果而设计了相关研究，并将其研究结果发表在Lancet Oncol 4月的在线期刊上。
本研究名为“采用断层X线摄相或标准钼靶检查筛查研究”（STORM）——是一个前瞻性对比研究。在本研究中所纳入的受试者为年龄在48岁及以上、需要进行乳腺癌筛查的无症状女性，这些女性来自于意大利的Trento和Verona，研究进行时间为2011年8月至2012年6月。研究为2个连续的部分，仅进行2D钼靶检查或综合2D和3D钼靶检查，并对检查结果分别进行判读。由乳腺放射学家进行阅片以此来确定是否需要召回钼靶检查结果显示阳性的受试者。根据最后的评估结果或切除病灶的组织学结果对本研究进行评价。本研究的主要终点为肿瘤的发现数、每1000名筛查者中肿瘤的发现数、假阳性召回者数目及所占的比例，以及综合2D和3D钼靶检查所检测到的肿瘤发生增量。
共有7292名女性进行了筛查，其中位年龄为58岁（IQR 54-63）。研究者在57名女性中间发现了59例乳腺癌病变（包括52例侵袭性肿瘤）。2D钼靶检查和综合2D和3D钼靶检查筛查所发现的肿瘤为39例。而有20例肿瘤仅被综合2D和3D钼靶检查所发现，而不能被2D钼靶检查法所发现，两者差异具有显著统计学意义。采用2D钼靶筛查法，每1000名受试者中可发现5.3例肿瘤（95%可信区间为3.8-7.3），而采用综合2D和3D钼靶筛查法，每1000名受试者中可发现8.1例肿瘤（95%可信区间为6.2-10.4）。在采用了综合2D和3D钼靶检查后所检测到的肿瘤的增量为每1000人2.7例肿瘤（95%可信区间1.7-4.2）。有395名受试者因假阳性结果而被召回（5.5%，95%可信区间为5.0-6.0），其中有181名受试者为两项筛查都显示为假阳性的，而141名为2D钼靶检查显示假阳性结果，另有73名受试者为综合2D和3D钼靶检查显示假阳性结果，两种筛查方式所造成的假阳性结果具有显著统计学意义。据研究者估计，在本研究的受试者人群中，采用综合2D和3D钼靶检查所确定的条件召回能在不遗漏肿瘤的基础上降低17.2%的假阳性率（95%可信区间为13.6%-21.3%）。
综合2D和3D钼靶检查能改善乳腺癌的发现率，并能降低因假阳性结果所造成的过度诊断。但是我们还需要进行随机对照研究，来比较2D钼靶检查和综合2D和3D钼靶检查对乳腺癌筛查的有效性。
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Integration of 3D digital mammography with tomosynthesis for population breast-cancer screening (STORM): a prospective comparison study
Background
Digital breast tomosynthesis with 3D images might overcome some of the limitations of conventional 2D mammography for detection of breast cancer. We investigated the effect of integrated 2D and 3D mammography in population breast-cancer screening.
Methods
Screening with Tomosynthesis OR standard Mammography (STORM) was a prospective comparative study. We recruited asymptomatic women aged 48 years or older who attended population-based breast-cancer screening through the Trento and Verona screening services (Italy) from August, 2011, to June, 2012. We did screen-reading in two sequential phases—2D only and integrated 2D and 3D mammography—yielding paired data for each screen. Standard double-reading by breast radiologists determined whether to recall the participant based on positive mammography at either screen read. Outcomes were measured from final assessment or excision histology. Primary outcome measures were the number of detected cancers, the number of detected cancers per 1000 screens, the number and proportion of false positive recalls, and incremental cancer detection attributable to integrated 2D and 3D mammography. We compared paired binary data with McNemar's test.
Findings
7292 women were screened (median age 58 years [IQR 54—63]). We detected 59 breast cancers (including 52 invasive cancers) in 57 women. Both 2D and integrated 2D and 3D screening detected 39 cancers. We detected 20 cancers with integrated 2D and 3D only versus none with 2D screening only (p<0·0001). Cancer detection rates were 5·3 cancers per 1000 screens (95% CI 3·8—7·3) for 2D only, and 8·1 cancers per 1000 screens (6·2—10·4) for integrated 2D and 3D screening. The incremental cancer detection rate attributable to integrated 2D and 3D mammography was 2·7 cancers per 1000 screens (1·7—4·2). 395 screens (5·5%; 95% CI 5·0—6·0) resulted in false positive recalls: 181 at both screen reads, and 141 with 2D only versus 73 with integrated 2D and 3D screening (p<0·0001). We estimated that conditional recall (positive integrated 2D and 3D mammography as a condition to recall) could have reduced false positive recalls by 17·2% (95% CI 13·6—21·3) without missing any of the cancers detected in the study population.
Interpretation
Integrated 2D and 3D mammography improves breast-cancer detection and has the potential to reduce false positive recalls. Randomised controlled trials are needed to compare integrated 2D and 3D mammography with 2D mammography for breast cancer screening.
Funding
National Breast Cancer Foundation, Australia; National Health and Medical Research Council, Australia; Hologic, USA; Technologic, Italy.