Department of Translational Medicine, Radiology Diagnostics, Lund University, Skåne University Hospital, Carl-Bertil Laurells Gata 9, 20502, Malmö, Sweden.
Department of Imaging and Physiology, Skåne University Hospital, Malmö, Sweden.
Breast Cancer Res. 2023 Oct 4;25(1):116. doi: 10.1186/s13058-023-01712-6.
The diagnostic accuracy of digital breast tomosynthesis (DBT) and digital mammography (DM) in breast cancer screening may vary per breast density subgroup. The purpose of this study was to evaluate which women, based on automatically assessed breast density subgroups, have the greatest benefit of DBT compared with DM in the prospective Malmö Breast Tomosynthesis Screening Trial.
The prospective European, Malmö Breast Tomosynthesis Screening Trial (n = 14,848, Jan. 27, 2010-Feb. 13, 2015) compared one-view DBT and two-view DM, with consensus meeting before recall. Breast density was assessed in this secondary analysis with the automatic software Laboratory for Individualized Breast Radiodensity Assessment. DBT and DM's diagnostic accuracies were compared by breast density quintiles of breast percent density (PD) and absolute dense area (DA) with confidence intervals (CI) and McNemar's test. The association between breast density and cancer detection was analyzed with logistic regression, adjusted for ages < 55 and ≥ 55 years and previous screening participation.
In total, 14,730 women (median age: 58 years; inter-quartile range = 16) were included in the analysis. Sensitivity was higher and specificity lower for DBT compared with DM for all density subgroups. The highest breast PD quintile showed the largest difference in sensitivity and specificity at 81.1% (95% CI 65.8-90.5) versus 43.2% (95% CI 28.7-59.1), p < .001 and 95.5% (95% CI 94.7-96.2) versus 97.2% (95% CI 96.6-97.8), p < 0.001, respectively. Breast PD quintile was also positively associated with cancer detected via DBT at odds ratio 1.24 (95% CI 1.09-1.42, p = 0.001).
Women with the highest breast density had the greatest benefit from digital breast tomosynthesis compared with digital mammography with increased sensitivity at the cost of slightly lower specificity. These results may influence digital breast tomosynthesis's use in an individualized screening program stratified by, for instance, breast density.
Trial registration at https://www.
gov : NCT01091545, registered March 24, 2010.
数字乳腺断层摄影术（DBT）和数字乳腺摄影术（DM）在乳腺癌筛查中的诊断准确性可能因乳腺密度亚组而异。本研究的目的是评估基于自动评估的乳腺密度亚组，在前瞻性马尔默乳腺断层摄影筛查试验中，与 DM 相比，DBT 对哪些女性的获益最大。
前瞻性的欧洲马尔默乳腺断层摄影筛查试验（n=14848，2010 年 1 月 27 日至 2015 年 2 月 13 日）比较了单视图 DBT 和双视图 DM，在召回前进行共识会议。在这项二次分析中，使用自动软件实验室个体化乳腺放射密度评估来评估乳腺密度。通过乳腺百分比密度（PD）和绝对致密区域（DA）的乳腺密度五分位数，比较 DBT 和 DM 的诊断准确性，置信区间（CI）和 McNemar 检验。使用逻辑回归分析乳腺密度与癌症检出的相关性，调整年龄<55 岁和≥55 岁以及以前的筛查参与。
共有 14730 名女性（中位年龄：58 岁；四分位数范围=16）纳入分析。与 DM 相比，DBT 在所有密度亚组中均显示出更高的敏感性和更低的特异性。最高的乳腺 PD 五分位数在敏感性和特异性方面的差异最大，分别为 81.1%（95%CI 65.8-90.5）和 43.2%（95%CI 28.7-59.1），p<0.001 和 95.5%（95%CI 94.7-96.2）和 97.2%（95%CI 96.6-97.8），p<0.001。乳腺 PD 五分位数也与 DBT 检测到的癌症呈正相关，优势比为 1.24（95%CI 1.09-1.42，p=0.001）。
与 DM 相比，乳腺密度最高的女性从数字乳腺断层摄影术获益最大，敏感性增加，特异性略有降低。这些结果可能会影响数字乳腺断层摄影术在基于乳腺密度等因素的个体化筛查计划中的应用。
https://www.clinicaltrials.gov 上的试验注册：NCT01091545，注册于 2010 年 3 月 24 日。
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