From the Radiology Unit (P.P., V.I., V.G., S.R., R.V.), Medical Physics Unit (A.N.), Epidemiology Unit (P.G.R.), Scientific Directorate (L.B., S.C.), and Screening Coordinating Centre (C.C.), AUSL Reggio Emilia, IRCCS, Via Amendola 2, Reggio Emilia 42122, Italy.
Radiology. 2018 Aug;288(2):375-385. doi: 10.1148/radiol.2018172119. Epub 2018 Jun 5.
Purpose To compare digital mammography (DM) plus digital breast tomosynthesis (DBT) versus DM alone for breast cancer screening in the Reggio Emilia Tomosynthesis trial, a two-arm test-and-treat randomized controlled trial. Materials and Methods For this trial, eligible women (45-70 years old) who previously participated in the Reggio Emilia screening program were invited for mammography. Consenting women were randomly assigned 1:1 to undergo DBT+DM or DM (both of which involved two projections and double reading). Women were treated according to the decision at DBT+DM. Sensitivity, recall rate, and positive predictive value (PPV) at baseline were determined; the ratios of these rates for DBT+DM relative to DM alone were determined. Results From March 2014 to March 2016, 9777 women were recruited to the DM+DBT arm of the study, and 9783 women were recruited to the DM arm (mean age, 56.2 vs 56.3 years). Recall was 3.5% in both arms; detection was 4.5 per 1000 (44 of 9783) and 8.6 per 1000 (83 of 9777), respectively (+89%; 95% confidence interval [CI]: 31, 72). PPV of the recall was 13.0% and 24.1%, respectively (P = .0002); 72 of 80 cancers found in the DBT+DM arm and with complete DBT imaging were positive at least at one DBT-alone reading. The greater detection rate for DM+DBT was stronger for ductal carcinoma in situ (+180%, 95% CI: 1, 665); it was notable for small and medium invasive cancers, but not for large ones (+94 [95% CI: 6, 254]; +122 [95% CI: 18, 316]; -12 [95% CI: -68, 141]; for invasive cancers < 10 mm, 10-19 mm, and ≥ 20 mm, respectively). Conclusion DBT+DM depicts 90% more cancers in a population previously screened with DM, with similar recall rates.
目的 在雷焦艾米利亚断层摄影术试验中，比较数字乳腺断层摄影术（DM）加数字乳腺断层合成术（DBT）与单独 DM 用于乳腺癌筛查的效果，这是一项双臂试验性治疗随机对照试验。
材料与方法 本试验中，之前参加过雷焦艾米利亚筛查项目的 45-70 岁符合条件的女性被邀请进行乳房 X 线摄影。同意的女性被随机分配 1:1 接受 DBT+DM 或 DM（两者均涉及两次投影和双次读片）。根据 DBT+DM 的决策对女性进行治疗。确定基线时的敏感性、召回率和阳性预测值（PPV）；确定 DBT+DM 相对于单独 DM 的这些率的比值。
结果 2014 年 3 月至 2016 年 3 月，9777 名女性被招募到 DM+DBT 研究组，9783 名女性被招募到 DM 组（平均年龄 56.2 岁比 56.3 岁）。在两组中，召回率均为 3.5%；检出率分别为每 1000 人 4.5 例（9783 例中 44 例）和 8.6 例（9777 例中 83 例）（+89%；95%置信区间[CI]：31，72）。召回的 PPV 分别为 13.0%和 24.1%（P =.0002）；在 DBT+DM 臂中发现的 80 例癌症中有 72 例至少在一次 DBT 单独读片中呈阳性，这些癌症均为导管原位癌。DM+DBT 的检出率更高，为 180%（95% CI：1，665）；在小中型浸润性癌中较为显著，但在大型浸润性癌中不显著（+94[95% CI：6，254]；+122[95% CI：18，316]；-12[95% CI：-68，141]；对于浸润性癌症<10mm、10-19mm 和≥20mm 分别）。
结论 在先前用 DM 筛查过的人群中，DBT+DM 可多检出 90%的癌症，而召回率相似。
