Comparison of Abbreviated Breast MRI vs Digital Breast Tomosynthesis for Breast Cancer Detection Among Women With Dense Breasts Undergoing Screening
Comparison of Abbreviated Breast MRI vs Digital Breast Tomosynthesis for Breast Cancer Detection Among Women With Dense Breasts Undergoing Screening
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DOI：
10.1001/jama.2020.0572
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发表时间：
2020-02-25
影响因子：
120.7
通讯作者：
Kuhl, Christiane K.
中科院分区：
文献类型：
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作者：
Comstock, Christopher E.;Gatsonis, Constantine;Kuhl, Christiane K.
重要性乳腺致密妇女需要改进筛查方法，因为她们患乳腺癌的风险增加，筛查性乳房X光检查早期诊断失败。目的比较简易乳腺磁共振成像（MRI）和数字乳腺断层合成摄影（DBT）对致密型乳腺的筛查效果。设计、设置和参与者是一项横断面研究，在美国和德国的48个学术、社区医院和私人诊所进行纵向随访，于2016年12月至2017年11月在40至75岁的平均风险女性中进行，这些女性患有不均匀致密或极致密乳房，接受常规筛查。癌症诊断的随访确认完成至2019年9月12日。所有女性均接受DBT和简化乳腺MRI筛查，以随机顺序进行，并独立阅读以避免解释偏倚。主要结果和测量主要终点是浸润性癌的检出率。次要结局包括敏感性、特异性、额外影像学推荐率和活检的阳性预测值（PPV），使用浸润性癌和导管原位癌（DCIS）定义阳性参考标准。所有成果都在参与者一级报告。核心或手术活检的病理学是癌症检出率和PPV的参考标准;在敏感性和特异性的参考标准中包括下一次年度筛查之前报告的间隔癌症。结果在1516名入选女性中，1444名（中位年龄54岁[范围40-75岁]）完成了两项检查并被纳入分析。17名妇女的浸润性癌伴或不伴DCIS的参考标准为阳性，另外6名妇女仅为DCIS。随访期间未观察到间隔期癌症。简化乳腺MRI检测到所有17例浸润性癌患者和6例DCIS中的5例。数字乳腺断层合成摄影检测到7/17例浸润性癌患者和2/6例DCIS患者。乳腺简化MRI的浸润性癌检出率为11.8（95% CI，7.4-18.8）/1000例女性，DBT为4.8（95% CI，2.4-10.0）/1000例女性，差异为7（95% CI，2.2-11.6）/1000例女性（精确McNemar P = 0.002）。对浸润性癌和DCIS的检测灵敏度为95.7%（95% CI，79.0%-99.2%），简化乳腺MRI vs 39.1%（95% CI，22.2%-59.2%），特异性分别为86.7%（95% CI，84.8%-88.4%）和97.4%（95% CI，96.5%-98.1%）（P < .001）。额外影像学推荐率为7.5%（95% CI，6.2%-9.0%），简化乳腺MRI vs 10.1%（95% CI，8.7%-11.8%），PPV分别为19.6%（95% CI，13.2%-28.2%）和31.0%（95% CI，17.0%-49.7%）（P = 0.15）。结论和相关性在接受筛查的致密乳腺妇女中，与DBT相比，简化乳腺MRI与浸润性乳腺癌检出率显著较高相关。需要进一步的研究来更好地了解筛查方法和临床结果之间的关系。
Importance Improved screening methods for women with dense breasts are needed because of their increased risk of breast cancer and of failed early diagnosis by screening mammography. Objective To compare the screening performance of abbreviated breast magnetic resonance imaging (MRI) and digital breast tomosynthesis (DBT) in women with dense breasts. Design, Setting, and Participants Cross-sectional study with longitudinal follow-up at 48 academic, community hospital, and private practice sites in the United States and Germany, conducted between December 2016 and November 2017 among average-risk women aged 40 to 75 years with heterogeneously dense or extremely dense breasts undergoing routine screening. Follow-up ascertainment of cancer diagnoses was complete through September 12, 2019. Exposures All women underwent screening by both DBT and abbreviated breast MRI, performed in randomized order and read independently to avoid interpretation bias. Main Outcomes and Measures The primary end point was the invasive cancer detection rate. Secondary outcomes included sensitivity, specificity, additional imaging recommendation rate, and positive predictive value (PPV) of biopsy, using invasive cancer and ductal carcinoma in situ (DCIS) to define a positive reference standard. All outcomes are reported at the participant level. Pathology of core or surgical biopsy was the reference standard for cancer detection rate and PPV; interval cancers reported until the next annual screen were included in the reference standard for sensitivity and specificity. Results Among 1516 enrolled women, 1444 (median age, 54 [range, 40-75] years) completed both examinations and were included in the analysis. The reference standard was positive for invasive cancer with or without DCIS in 17 women and for DCIS alone in another 6. No interval cancers were observed during follow-up. Abbreviated breast MRI detected all 17 women with invasive cancer and 5 of 6 women with DCIS. Digital breast tomosynthesis detected 7 of 17 women with invasive cancer and 2 of 6 women with DCIS. The invasive cancer detection rate was 11.8 (95% CI, 7.4-18.8) per 1000 women for abbreviated breast MRI vs 4.8 (95% CI, 2.4-10.0) per 1000 women for DBT, a difference of 7 (95% CI, 2.2-11.6) per 1000 women (exact McNemar P = .002). For detection of invasive cancer and DCIS, sensitivity was 95.7% (95% CI, 79.0%-99.2%) with abbreviated breast MRI vs 39.1% (95% CI, 22.2%-59.2%) with DBT (P = .001) and specificity was 86.7% (95% CI, 84.8%-88.4%) vs 97.4% (95% CI, 96.5%-98.1%), respectively (P < .001). The additional imaging recommendation rate was 7.5% (95% CI, 6.2%-9.0%) with abbreviated breast MRI vs 10.1% (95% CI, 8.7%-11.8%) with DBT (P = .02) and the PPV was 19.6% (95% CI, 13.2%-28.2%) vs 31.0% (95% CI, 17.0%-49.7%), respectively (P = .15). Conclusions and Relevance Among women with dense breasts undergoing screening, abbreviated breast MRI, compared with DBT, was associated with a significantly higher rate of invasive breast cancer detection. Further research is needed to better understand the relationship between screening methods and clinical outcome.