Departments of Medicine and Epidemiology and Biostatistics, University of California, San Francisco.
General Internal Medicine Section, Department of Veterans Affairs, University of California, San Francisco.
JAMA. 2022 Jun 14;327(22):2220-2230. doi: 10.1001/jama.2022.7672.
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.
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.
Breast Imaging Reporting and Data System (BI-RADS) breast density; BCSC 5-year breast cancer risk.
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.
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).
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.
数字乳腺断层合成术（DBT）的开发预期可以提高致密乳腺女性的癌症检出率。需要研究评估乳腺癌死亡率相关的乳腺癌间隔期浸润性和晚期癌症发生率以及中间结果，包括乳腺密度和乳腺癌风险。
评估与数字乳腺 X 线摄影相比，DBT 筛查是否与乳腺密度和乳腺癌风险相关的间隔期浸润性癌和晚期乳腺癌的可能性较低相关。
设计、设置和参与者：这是一项在美国 44 个美国乳腺癌监测联合会（BCSC）设施进行的 504427 名年龄在 40 岁至 79 岁之间的女性的队列研究，这些女性在 2011 年至 2018 年期间接受了 1003900 次筛查数字乳腺 X 线摄影和 375189 次筛查 DBT 检查，通过与州或地区癌症登记处的链接，对癌症诊断进行了随访，随访时间截至 2019 年。
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。
估计通过逆概率加权法，在数字乳腺 X 线摄影后 12 个月内间隔期浸润性癌和数字乳腺 X 线摄影后 12 个月内高级别乳腺癌（预后病理分期 II 级或更高）的发生率，每 1000 次检查的发生率。
在研究人群中，504427 名女性的中位年龄为 58 岁（IQR，50-65 岁）。DBT 与数字乳腺 X 线摄影相比，间隔期浸润性癌的发生率没有显著差异（总体分别为 0.57 比 0.61，差异为-0.04；95%CI，-0.14 至 0.06；P=0.43），或在所有 836250 次 BCSC 5 年风险低于 1.67%（低到平均风险）的检查中，或在所有 413061 次 BCSC 5 年风险为 1.67%或更高的检查中（高风险），乳腺密度分类。在低至平均风险或高风险且几乎完全为脂肪、散在纤维腺体密度或异质性致密乳房的女性中，DBT 与数字乳腺 X 线摄影相比，高级别癌症的发生率也没有显著差异。在乳腺密度为极高风险（DBT 组有 13291 次检查，数字乳腺 X 线摄影组有 31300 次检查；每 1000 次检查 0.27 比 0.80；差异-0.53；95%CI，-0.97 至-0.10）的女性中，DBT 与数字乳腺 X 线摄影相比，高级别癌症的发生率显著降低，但在低至平均风险的女性中（DBT 组有 10611 次检查，数字乳腺 X 线摄影组有 37796 次检查；每 1000 次检查 0.54 比 0.42；差异 0.12；95%CI，-0.09 至 0.32）。
与数字乳腺 X 线摄影相比，DBT 筛查与间隔期浸润性癌症风险无显著差异，与极高乳腺密度和高乳腺癌风险的女性中，高级别乳腺癌的风险显著降低。在 96.4%无致密乳腺、异质性致密乳腺或高乳腺癌风险的极度致密乳腺的女性中，未观察到显著差异。
