Division of Radiology and Nuclear Medicine, Breast Imaging Center, Oslo University Hospital, University of Oslo, Kirkeveien 166, 0407, Oslo, Norway.
Department of Screening, Cancer Registry of Norway, Oslo, Norway.
Breast Cancer Res Treat. 2018 Jun;169(3):489-496. doi: 10.1007/s10549-018-4705-2. Epub 2018 Feb 10.
Digital breast tomosynthesis (DBT) has the potential to overcome limitations of conventional mammography. This study investigated the effects of addition of DBT on interval and detected cancers in population-based screening.
Oslo Tomosynthesis Screening Trial (OTST) was a prospective, independent double-reading trial inviting women 50-69 years biennially, comparing full-field digital mammography (FFDM) plus DBT with FFDM alone. Performance indicators and characteristics of screen-detected and interval cancers were compared with two previous FFDM rounds.
24,301 consenting women underwent FFDM + DBT screening over a 2-year period. Results were compared with 59,877 FFDM examinations during prior rounds. Addition of DBT resulted in a non-significant increase in sensitivity (76.2%, 378/496, vs. 80.8%, 227/281, p = 0.151) and a significant increase in specificity (96.4%, 57229/59381 vs. 97.5%, 23427/24020, p < .001). Number of recalls per screen-detected cancer decreased from 6.7 (2530/378) to 3.6 (820/227) with DBT (p < .001). Cancer detection per 1000 women screened increased (6.3, 378/59877, vs. 9.3, 227/24301, p < .001). Interval cancer rate per 1000 screens for FFDM + DBT remained similar to previous FFDM rounds (2.1, 51/24301 vs. 2.0, 118/59877, p = 0.734). Interval cancers post-DBT were comparable to prior rounds but significantly different in size, grade, and node status from cancers detected only using DBT. 39.6% (19/48) of interval cancers had positive nodes compared with only 3.9% (2/51) of additional DBT-only-detected cancers.
DBT-supplemented screening resulted in significant increases in screen-detected cancers and specificity. However, no significant change was observed in the rate, size, node status, or grade of interval cancers. ClinicalTrials.gov: NCT01248546.
数字乳腺断层合成术（DBT）具有克服传统乳腺摄影局限性的潜力。本研究调查了在基于人群的筛查中添加 DBT 对间期和检出癌症的影响。
奥斯陆断层合成术筛查试验（OTST）是一项前瞻性、独立的双阅读试验，邀请 50-69 岁的女性每两年进行一次检查，比较全数字化乳腺摄影术（FFDM）加 DBT 与单独使用 FFDM。比较了屏幕检出癌和间期癌的检测指标和特征与前两轮 FFDM 结果。
24301 名同意参加的女性在 2 年内接受了 FFDM+DBT 筛查，结果与之前两轮的 59877 次 FFDM 检查进行了比较。添加 DBT 后，灵敏度（76.2%，378/496，vs. 80.8%，227/281，p=0.151）有非显著性增加，特异性（96.4%，57229/59381，vs. 97.5%，23427/24020，p<0.001）有显著增加。每例检出癌的召回次数从 DBT 前的 6.7（2530/378）降至 3.6（820/227）（p<0.001）。每 1000 名筛查妇女的癌症检出率增加（6.3，378/59877，vs. 9.3，227/24301，p<0.001）。FFDM+DBT 的间期癌率与前两轮 FFDM 相似（2.1，51/24301，vs. 2.0，118/59877，p=0.734）。DBT 后的间期癌与前几轮相似，但在大小、分级和淋巴结状态方面与仅用 DBT 检出的癌症明显不同。48 例（39.6%）间期癌有阳性淋巴结，而仅 51 例（2.0%）DBT 仅检出的癌症有阳性淋巴结。
DBT 补充筛查显著增加了检出的癌症和特异性。然而，间期癌的发生率、大小、淋巴结状态或分级均无显著变化。ClinicalTrials.gov：NCT01248546。
