荷兰乌得勒支大学医学中心Carla H. van Gils研究组探讨了对乳腺组织密度极高的妇女进行补充MRI筛查的意义。这一研究成果于2019年11月28日发表在国际顶尖学术期刊《新英格兰医学杂志》上。

乳腺组织密度过大是乳腺癌的危险因素，限制了乳腺影像对癌症的检测。

研究组在荷兰进行了一项多中心、随机、对照试验，招募了40373名年龄为50-75岁、乳腺组织密度极高、乳腺钼靶结果正常的女性，按1：4将其随机分组，邀请8061例接受补充MRI检查，32312例仅接受钼靶检查。

在2年的筛查期内，MRI邀请组的癌症发生率为2.5/1000，仅钼靶组为5.0/1000，差异显著。MRI邀请组中有59%的人进行了MRI检查。MRI邀请组中共有20例患者确诊癌症，其中接受MRI检查组中有4例（0.8/1000），未接受MRI检查组中有16例（4.9/1000）。

在实际接受MRI筛查的女性中，MRI癌症的检出率为16.5/1000。召回进行附加检查后的阳性预测值为17.4%，活检的阳性预测值为26.3%。假阳性率为79.8/1000。0.1%接受MRI检查的女性在筛查期间或筛查后立即出现不良事件或严重不良事件。

对乳腺组织密度极高且钼靶检查结果正常的女性进行补充MRI筛查，在2年的筛查期内，患癌率显著低于单纯的钼靶检查。

附：英文原文

Title: Supplemental MRI Screening for Women with Extremely Dense Breast Tissue

Author: Marije F. Bakker, Ph.D.,, Stéphanie V. de Lange, M.D.,, Ruud M. Pijnappel, M.D., Ph.D.,, Ritse M. Mann, M.D., Ph.D.,, Petra H.M. Peeters, M.D., Ph.D.,, Evelyn M. Monninkhof, Ph.D.,, Marleen J. Emaus, Ph.D.,, Claudette E. Loo, M.D., Ph.D.,, Robertus H.C. Bisschops, M.D., Ph.D.,, Marc B.I. Lobbes, M.D., Ph.D.,, Matthijn D.F. de Jong, M.D.,, Katya M. Duvivier, M.D.,, Jeroen Veltman, M.D., Ph.D.,, Nico Karssemeijer, Ph.D.,, Harry J. de Koning, M.D., Ph.D.,, Paul J. van Diest, M.D., Ph.D.,, Willem P.T.M. Mali, M.D., Ph.D.,, Maurice A.A.J. van den Bosch, M.D., Ph.D.,, Wouter B. Veldhuis, M.D., Ph.D.,, and Carla H. van Gils, Ph.D.

Issue&Volume: 2019-11-27

Abstract: 

BACKGROUND
Extremely dense breast tissue is a risk factor for breast cancer and limits the detection of cancer with mammography. Data are needed on the use of supplemental magnetic resonance imaging (MRI) to improve early detection and reduce interval breast cancers in such patients.

METHODS
In this multicenter, randomized, controlled trial in the Netherlands, we assigned 40,373 women between the ages of 50 and 75 years with extremely dense breast tissue and normal results on screening mammography to a group that was invited to undergo supplemental MRI or to a group that received mammography screening only. The groups were assigned in a 1:4 ratio, with 8061 in the MRI-invitation group and 32,312 in the mammography-only group. The primary outcome was the between-group difference in the incidence of interval cancers during a 2-year screening period.

RESULTS
The interval-cancer rate was 2.5 per 1000 screenings in the MRI-invitation group and 5.0 per 1000 screenings in the mammography-only group, for a difference of 2.5 per 1000 screenings (95% confidence interval [CI], 1.0 to 3.7; P<0.001). Of the women who were invited to undergo MRI, 59% accepted the invitation. Of the 20 interval cancers that were diagnosed in the MRI-invitation group, 4 were diagnosed in the women who actually underwent MRI (0.8 per 1000 screenings) and 16 in those who did not accept the invitation (4.9 per 1000 screenings). The MRI cancer-detection rate among the women who actually underwent MRI screening was 16.5 per 1000 screenings (95% CI, 13.3 to 20.5). The positive predictive value was 17.4% (95% CI, 14.2 to 21.2) for recall for additional testing and 26.3% (95% CI, 21.7 to 31.6) for biopsy. The false positive rate was 79.8 per 1000 screenings. Among the women who underwent MRI, 0.1% had either an adverse event or a serious adverse event during or immediately after the screening.

CONCLUSIONS
The use of supplemental MRI screening in women with extremely dense breast tissue and normal results on mammography resulted in the diagnosis of significantly fewer interval cancers than mammography alone during a 2-year screening period. (Funded by the University Medical Center Utrecht and others; DENSE ClinicalTrials.gov number, NCT01315015. opens in new tab.)

DOI: NJ201911283812205

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa1903986