Importance Digital breast tomosynthesis (DBT) was developed with the expectation of improving cancer detection in women with dense breasts. Studies are needed to evaluate interval invasive and advanced breast cancer rates, intermediary outcomes related to breast cancer mortality, by breast density and breast cancer risk. Objective To evaluate whether DBT screening is associated with a lower likelihood of interval invasive cancer and advanced breast cancer compared with digital mammography by extent of breast density and breast cancer risk. Design, Setting, and Participants Cohort study of 504 427 women aged 40 to 79 years who underwent 1 003 900 screening digital mammography and 375 189 screening DBT examinations from 2011 through 2018 at 44 US Breast Cancer Surveillance Consortium (BCSC) facilities with follow-up for cancer diagnoses through 2019 by linkage to state or regional cancer registries. Exposures Breast Imaging Reporting and Data System (BI-RADS) breast density; BCSC 5-year breast cancer risk. Main Outcomes and Measures Rates per 1000 examinations of interval invasive cancer within 12 months of screening mammography and advanced breast cancer (prognostic pathologic stage II or higher) within 12 months of screening mammography, both estimated with inverse probability weighting. Results Among 504 427 women in the study population, the median age at time of mammography was 58 years (IQR, 50-65 years). Interval invasive cancer rates per 1000 examinations were not significantly different for DBT vs digital mammography (overall, 0.57 vs 0.61, respectively; difference, -0.04; 95% CI, -0.14 to 0.06; P = .43) or among all the 836 250 examinations with BCSC 5-year risk less than 1.67% (low to average-risk) or all the 413 061 examinations with BCSC 5-year risk of 1.67% or higher (high risk) across breast density categories. Advanced cancer rates were not significantly different for DBT vs digital mammography among women at low to average risk or at high risk with almost entirely fatty, scattered fibroglandular densities, or heterogeneously dense breasts. Advanced cancer rates per 1000 examinations were significantly lower for DBT vs digital mammography for the 3.6% of women with extremely dense breasts and at high risk of breast cancer (13 291 examinations in the DBT group and 31 300 in the digital mammography group; 0.27 vs 0.80 per 1000 examinations; difference, -0.53; 95% CI, -0.97 to -0.10) but not for women at low to average risk (10 611 examinations in the DBT group and 37 796 in the digital mammography group; 0.54 vs 0.42 per 1000 examinations; difference, 0.12; 95% CI, -0.09 to 0.32). Conclusions and Relevance Screening with DBT vs digital mammography was not associated with a significant difference in risk of interval invasive cancer and was associated with a significantly lower risk of advanced breast cancer among the 3.6% of women with extremely dense breasts and at high risk of breast cancer. No significant difference was observed in the 96.4% of women with nondense breasts, heterogeneously dense breasts, or with extremely dense breasts not at high risk.

中文翻译：

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数字乳腺断层合成筛查与数字乳腺 X 线摄影筛查与间期浸润性和晚期乳腺癌风险的关联。

重要性 数字乳房断层合成 (DBT) 的开发旨在改善乳房致密女性的癌症检测。需要研究通过乳腺密度和乳腺癌风险来评估间期浸润性和晚期乳腺癌发生率、与乳腺癌死亡率相关的中间结果。目的 通过乳腺密度和乳腺癌风险程度，评估与数字乳房 X 光检查相比，DBT 筛查是否与较低的间期浸润癌和晚期乳腺癌可能性相关。设计、设置和参与者 对 504 427 名 40 至 79 岁女性进行的队列研究，她们从 2011 年至 2018 年在 44 个美国乳腺癌监测联盟 (BCSC) 机构接受了 1 003 900 次数字乳房 X 光检查和 375 189 次 DBT 筛查检查，并进行了随访通过与州或地区癌症登记处的联系进行 2019 年癌症诊断。暴露乳腺成像报告和数据系统 (BI-RADS) 乳腺密度；BCSC 5 年乳腺癌风险。主要结果和措施 筛查乳房 X 光检查 12 个月内每 1000 次间期浸润性癌症的检查率和筛查乳房 X 光检查 12 个月内晚期乳腺癌（预后病理分期 II 期或更高）的比率，均采用逆概率加权估计。结果 在研究人群中的 504 427 名女性中，进行乳房 X 光检查时的中位年龄为 58 岁（IQR，50-65 岁）。DBT 与数字乳房 X 光检查的每 1000 次检查的间隔浸润癌发生率没有显着差异（总体分别为 0.57 与 0.61；差异，-0.04；95% CI，-0.14 至 0.06；P = .43）或在所有 836 250 名患者中BCSC 5 年风险低于 1.67%（低至平均风险）的检查或所有 413 061 项检查，跨乳腺密度类别 BCSC 5 年风险为 1.67% 或更高（高风险）。对于低至平均风险或几乎完全是脂肪、分散的纤维腺体密度或不均匀致密乳房的高风险女性，DBT 与数字乳房 X 光检查的晚期癌症发生率没有显着差异。对于 3.6% 的乳房极其致密且乳腺癌风险较高的女性，每 1000 次检查的晚期癌症发生率显着低于数字乳房 X 光检查（DBT 组进行了 13 291 次检查，数字乳房 X 光检查组进行了 31 300 次检查；0.27 vs 0.27）。每 1000 次检查为 0.80 次；差异为 -0.53；95% CI，-0.97 至 -0.10），但对于低至平均风险的女性则不然（DBT 组进行了 10 611 次检查，数字乳房 X 光检查组进行了 37 796 次检查；每 1000 次检查分别为 0.54 次和 0.42 次）。 1000 次检查；差异，0.12；95% CI，-0.09 至 0.32）。结论和相关性 DBT 筛查与数字乳房 X 光检查与间期浸润性癌症风险的显着差异无关，并且与 3.6% 乳房密度极高且乳腺癌风险高的女性患晚期乳腺癌的风险显着降低相关癌症。