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致密型乳腺女性的补充性磁共振成像筛查。

Supplemental MRI Screening for Women with Extremely Dense Breast Tissue.

机构信息

From the Julius Center for Health Sciences and Primary Care (M.F.B., S.V.L., P.H.M.P., E.M.M., C.H.G.) and the Departments of Radiology (S.V.L., R.M.P., M.J.E., W.P.T.M.M., M.A.A.J.B., W.B.V.) and Pathology (P.J.D.), University Medical Center Utrecht, Utrecht University, Utrecht, the Dutch Expert Center for Screening (R.M.P.) and the Department of Radiology, Radboud University Nijmegen Medical Center (R.M.M., N.K.), Nijmegen, the Department of Radiology, Antoni van Leeuwenhoek Hospital (C.E.L.), and the Department of Radiology and Nuclear Medicine, Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam (K.M.D.), Amsterdam, the Department of Radiology, Albert Schweitzer Hospital, Dordrecht (R.H.C.B.), the Department of Radiology and Nuclear Medicine, Maastricht University Medical Center, Maastricht, and the Department of Medical Imaging, Zuyderland Medical Center, Sittard-Geleen (M.B.I.L.), the Department of Radiology, Jeroen Bosch Hospital, 's-Hertogenbosch (M.D.F.J.), the Department of Radiology, Hospital Group Twente, Almelo (J.V.), and the Department of Public Health, Erasmus Medical Center, Rotterdam (H.J.K.) - all in the Netherlands; and the Department of Epidemiology and Biostatistics, School of Public Health, Faculty of Medicine, Imperial College London, London (P.H.M.P.).

出版信息

N Engl J Med. 2019 Nov 28;381(22):2091-2102. doi: 10.1056/NEJMoa1903986.

DOI:10.1056/NEJMoa1903986

PMID:31774954

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.).

摘要

背景

致密型乳腺组织是乳腺癌的一个危险因素，并限制了通过乳房 X 光摄影术对癌症的检测。需要有关于使用补充性磁共振成像（MRI）来改善早期检测和减少此类患者的间期乳腺癌的数据。

方法

在荷兰的这项多中心、随机、对照试验中，我们将 40373 名年龄在 50 至 75 岁之间、乳腺组织致密且乳房 X 光筛查结果正常的女性分配到一个接受补充性 MRI 检查的组或一个仅接受乳房 X 光筛查的组。两组的分配比例为 1:4，MRI 邀请组有 8061 名女性，仅接受乳房 X 光筛查组有 32312 名女性。主要结局是在 2 年筛查期间，组间间期癌发病率的差异。

结果

在 MRI 邀请组中，间期癌的发生率为每 1000 次筛查 2.5 例，在仅接受乳房 X 光筛查组中为每 1000 次筛查 5.0 例，差异为每 1000 次筛查 2.5 例（95%置信区间 [CI]，1.0 至 3.7；P<0.001）。在被邀请接受 MRI 的女性中，有 59%接受了邀请。在 MRI 邀请组中诊断的 20 例间期癌中，有 4 例在实际接受 MRI 检查的女性中诊断（每 1000 次筛查 0.8 例），16 例在未接受邀请的女性中诊断（每 1000 次筛查 4.9 例）。实际接受 MRI 筛查的女性中 MRI 癌症检出率为每 1000 次筛查 16.5 例（95%CI，13.3 至 20.5）。召回进行进一步检测的阳性预测值为 17.4%（95%CI，14.2 至 21.2），活检的阳性预测值为 26.3%（95%CI，21.7 至 31.6）。假阳性率为每 1000 次筛查 79.8 例。在接受 MRI 的女性中，有 0.1%在筛查期间或之后立即发生不良事件或严重不良事件。