Ban Kanako, Tsunoda Hiroko, Togashi Seiko, Kawaguchi Yuko, Sato Takanobu, Takahashi Yoko, Nagatsuka Yoshitaka
Tokyo Health Service Association, 1-2, Ichigaya-sadohara-cho, Shinjuku-ku, Tokyo, 162-8402, Japan.
St Luke's International Hospital, 9-1, Akashi-cho, Chuo-ku, Tokyo, 104-8560, Japan.
Breast Cancer. 2021 Mar;28(2):459-464. doi: 10.1007/s12282-020-01180-2. Epub 2020 Nov 9.
The purpose of this study is to confirm the position of DBT in breast cancer screening in Japan, to assess cancer detection rates, recall rates, positive predictive value (PPV), and to evaluate the type of mammographic findings of cancer with the use of digital mammography alone (2DDM) and combined with digital breast tomosynthesis (DBT).
11,894 examinations of the opportunistic breast cancer screening using only 2DDM and 2DDM plus DBT were performed from May 1, 2017 to March 31, 2019. The 11,894 women [3535 women who received DBT in addition to 2DDM (3D group) and 8359 who received 2DDM only (2D group)] participated in this study. The study was approved by the Institute's Ethics Committee and all participants provided written informed consent.
The recall rate was 2.6% for the 3D group and 3.6% for the 2D group (p < 0.01). The cancer detection rate was 0.17% in both 3D and 2D groups (p = 0.978). The positive predictive value (PPV) was 6.5% for the 3D group and 4.7% for the 2D group (p = 0.484). The cause of the decrease in recall rate was due to a decrease in the finding of focal asymmetric density (FAD).
The recall rate was improved by using DBT for breast cancer screening in Japanese women. Cancer detection rates were exactly the same in DBT and 2DDM groups, so only DBT non-inferiority could be verified. We have verified that breast cancer screening combined with DBT is useful even for Japanese women to reduce unnecessary further examination.
本研究旨在确定数字乳腺断层合成（DBT）在日本乳腺癌筛查中的地位，评估癌症检出率、召回率、阳性预测值（PPV），并使用单纯数字乳腺摄影（2DDM）以及联合数字乳腺断层合成（DBT）来评估乳腺癌的乳腺摄影表现类型。
2017年5月1日至2019年3月31日期间，共进行了11,894例机会性乳腺癌筛查检查，其中仅使用2DDM以及2DDM联合DBT。11,894名女性[3535名除2DDM外还接受DBT的女性（3D组）和8359名仅接受2DDM的女性（2D组）]参与了本研究。该研究获得了研究所伦理委员会的批准，所有参与者均提供了书面知情同意书。
3D组的召回率为2.6%，2D组为3.6%（p<0.01）。3D组和2D组的癌症检出率均为0.17%（p = 0.978）。3D组的阳性预测值（PPV）为6.5%，2D组为4.7%（p = 0.484）。召回率下降的原因是局灶性不对称密度（FAD）的发现减少。
在日本女性乳腺癌筛查中使用DBT可提高召回率。DBT组和2DDM组的癌症检出率完全相同，因此仅能证实DBT的非劣效性。我们已经证实，联合DBT的乳腺癌筛查对于日本女性减少不必要的进一步检查也是有用的。
