From the Clinic for Radiology and Reference Center for Mammography Münster (S.W., W.H., T.D.), Institute of Biostatistics and Clinical Research (V.W.E., L.K., J.G.), and Institute of Epidemiology and Social Medicine (H.W.H.), University of Münster and University Hospital Münster, Albert-Schweitzer-Campus 1, Building A1, D-48149 Münster, Germany.
Radiology. 2023 Dec;309(3):e231533. doi: 10.1148/radiol.231533.
Background Breast cancer screening with digital breast tomosynthesis (DBT) plus synthesized mammography (SM) increases invasive tumor detection compared with digital mammography (DM). However, it is not known how the prognostic characteristics of the cancers detected with the two screening approaches differ. Purpose To compare invasive breast cancers detected with DBT plus SM (test arm) versus DM (control arm) screening with regard to tumor stage, histologic grade, patient age, and breast density. Materials and Methods This exploratory subanalysis of the Tomosynthesis plus Synthesized Mammography (TOSYMA) study, which is a multicenter randomized controlled trial embedded in the German mammography screening program, recruited women aged 50-70 years from July 2018 to December 2020. It compared invasive cancer detection rates (iCDRs), rate differences, and odds ratios (ORs) between the arms stratified by Union for International Cancer Control (UICC) stage (I vs II-IV), histologic grade (1 vs 2 or 3), age group (50-59 vs 60-70 years), and Breast Imaging Reporting and Data System categories of breast density (A or B vs C or D). Results In total, 49 462 (median age, 57 years [IQR, 53-62 years]) and 49 669 (median age, 57 years [IQR, 53-62 years]) participants were allocated to DBT plus SM and DM screening, respectively. The iCDR of stage I tumors with DBT plus SM was 51.6 per 10 000 women (255 of 49 462) and with DM it was 30.0 per 10 000 women (149 of 49 669). DBT plus SM depicted more stage I tumors with grade 2 or 3 (166 of 49 462, 33.7 per 10 000 women) than DM (106 of 49 669, 21.3 per 10 000 women; rate difference, +12.3 per 10 000 women [95% CI: 0.3, 24.9]; OR, 1.6 [95% CI: 0.9, 2.7]). DBT plus SM achieved the highest iCDR of stage I tumors with grade 2 or 3 among women aged 60-70 years with dense breasts (41 of 7364, 55.4 per 10 000 women; rate difference, +21.6 per 10 000 women [95% CI: -21.1, 64.3]; OR, 1.6 [95% CI: 0.6, 4.5]). Conclusion DBT plus SM screening appears to lead to higher detection of early-stage invasive breast cancers of grade 2 or 3 than DM screening, with the highest rate among women aged 60-70 years with dense breasts. Clinical trial registration no. NCT03377036 © RSNA, 2023 See also the editorial by Ha and Chang in this issue.
背景 与数字乳腺断层合成摄影术（DBT）加合成乳房 X 线摄影术（SM）相比，数字乳腺 X 线摄影术（DM）筛查可增加浸润性肿瘤的检出率。然而，目前尚不清楚两种筛查方法检测到的癌症的预后特征有何不同。
目的 本研究旨在比较 DBT 加 SM（试验组）与 DM（对照组）筛查中浸润性乳腺癌的肿瘤分期、组织学分级、患者年龄和乳腺密度。
材料与方法 本研究是 Tomosynthesis plus Synthesized Mammography（TOSYMA）研究的探索性亚分析，这是一项多中心随机对照试验，嵌入德国乳腺筛查计划中，招募了 2018 年 7 月至 2020 年 12 月年龄在 50-70 岁的女性。它比较了试验组和对照组之间根据国际抗癌联盟（UICC）分期（I 期 vs II-IV 期）、组织学分级（1 级 vs 2 或 3 级）、年龄组（50-59 岁 vs 60-70 岁）和乳腺成像报告和数据系统（BI-RADS）乳腺密度类别（A 或 B 级 vs C 或 D 级）的浸润性癌症检出率（iCDR）、率差和比值比（OR）。
结果 共有 49462 名（中位年龄为 57 岁[IQR，53-62 岁]）和 49669 名（中位年龄为 57 岁[IQR，53-62 岁]）参与者分别被分配到 DBT 加 SM 和 DM 筛查组。DBT 加 SM 组 I 期肿瘤的 iCDR 为 51.6/10000 名妇女（49462 名中的 255 名），DM 组为 30.0/10000 名妇女（49669 名中的 149 名）。DBT 加 SM 组比 DM 组更能检测到更多的 II 期或 III 期肿瘤（166/49462，33.7/10000 名妇女；率差，+12.3/10000 名妇女[95%CI：0.3，24.9]；OR，1.6[95%CI：0.9，2.7]）。DBT 加 SM 组在乳腺致密的 60-70 岁女性中 I 期肿瘤的 II 级或 3 级肿瘤的 iCDR 最高（7364 名中的 41 名，55.4/10000 名妇女；率差，+21.6/10000 名妇女[95%CI：-21.1，64.3]；OR，1.6[95%CI：0.6，4.5]）。
结论 DBT 加 SM 筛查似乎比 DM 筛查更能检测到 II 级或 3 级的早期浸润性乳腺癌，在乳腺致密的 60-70 岁女性中检出率最高。
临床试验注册号 NCT03377036 © RSNA，2023 请同时参见本期 Ha 和 Chang 的社论。
