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.).

中文翻译：

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乳腺极致密组织女性的MRI补充筛查。

背景技术极致密的乳房组织是乳腺癌的危险因素，并限制了用乳房X线照相术对癌症的检测。需要使用补充磁共振成像（MRI）的数据来改善此类患者的早期发现并减少间隔性乳腺癌。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，乳房组织非常致密且乳房X线检查结果正常的妇女分为一组，进行了补充MRI检查或一组仅接受了乳房X线检查的患者。这些组以1：4的比例分配，其中MRI邀请组为8061，仅乳房X线照相术的组为32,312。主要结果是在为期2年的筛查期间，间隔癌的发生率之间存在组间差异。结果MRI邀请组的间隔癌率为2.5 / 1000次筛查，仅乳房X线照相术的组为1000 / 5.0次筛查，相差2.5 / 1000筛查（95％置信区间[CI]为1.0至3.7； P ＜0.001）。受邀接受MRI检查的女性中，有59％接受了邀请。在MRI邀请组中诊断出的20种间断性癌症中，确诊过MRI的女性中确诊了4例（每1000次筛查中有0.8例），而没有接受邀请的女性中有16例（每1000筛查中有4.9例）被诊断出。实际接受过MRI筛查的女性的MRI癌症检出率为每1000例筛查16.5例（95％CI，13.3至20.5）。再次检查的阳性预测值为17.4％（95％CI，14.2至21.2），而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。在接受MRI检查的女性中，有0.1％在筛查期间或筛查后出现不良事件或严重不良事件。结论在乳腺组织非常致密且乳房X线检查结果正常的女性中，使用辅助MRI筛查可在2年的筛查期间诊断出间隔癌，其诊断率明显低于单纯乳房X线检查。（由乌得勒支大学医学中心等资助； DENSE ClinicalTrials.gov编号，NCT01315015。）。结论在乳腺组织非常致密且乳房X线检查结果正常的女性中，使用辅助MRI筛查可在2年的筛查期间诊断出间隔癌，其诊断率明显低于单纯乳房X线检查。（由乌得勒支大学医学中心等资助； DENSE ClinicalTrials.gov编号，NCT01315015。）。结论在乳腺组织非常致密且乳房X线检查结果正常的女性中，使用辅助MRI筛查可在2年的筛查期间诊断出间隔癌，其诊断率明显低于单纯乳房X线检查。（由乌得勒支大学医学中心等资助； DENSE ClinicalTrials.gov编号，NCT01315015。）。