致密型乳腺女性补充性乳腺 MRI 检查：DENSE 试验第二轮筛查结果。
Supplemental Breast MRI for Women with Extremely Dense Breasts: Results of the Second Screening Round of the DENSE Trial.
机构信息
From the Julius Center for Health Sciences and Primary Care (S.G.A.V., S.V.d.L., M.F.B., E.M.M., C.H.v.G.), Department of Radiology (S.V.d.L., R.M.P., M.J.E., W.P.T.M.M., M.A.A.J.v.d.B., W.B.V.), and Department of Pathology (P.J.v.D.), University Medical Center Utrecht, Utrecht University, STR 6.131, PO Box 85500, 3508 GA Utrecht, the Netherlands; Dutch Expert Centre for Screening, Nijmegen, the Netherlands (R.M.P.); Department of Radiology, Radboud University Nijmegen Medical Center, Nijmegen, the Netherlands (R.M.M., N.K.); Department of Radiology, the Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Amsterdam, the Netherlands (P.K.d.K.D.); Department of Radiology, Albert Schweitzer Hospital, Dordrecht, the Netherlands (R.H.C.B.); Department of Radiology and Nuclear Medicine, Maastricht University Medical Centre, Maastricht, the Netherlands (M.B.I.L.); Department of Medical Imaging, Zuyderland Medical Centre, Sittard-Geleen, the Netherlands (M.B.I.L.); Department of Radiology, Jeroen Bosch Hospital, 's-Hertogenbosch, the Netherlands (M.D.F.d.J.); Department of Radiology and Nuclear Medicine, Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands (K.M.D.); Department of Radiology, Hospital Group Twente (ZGT), Almelo, the Netherlands (J.V.); and Department of Public Health, Erasmus Medical Center, Rotterdam, the Netherlands (H.J.d.K.).
出版信息
Radiology. 2021 May;299(2):278-286. doi: 10.1148/radiol.2021203633. Epub 2021 Mar 16.
Background In the first (prevalent) supplemental MRI screening round of the Dense Tissue and Early Breast Neoplasm Screening (DENSE) trial, a considerable number of breast cancers were found at the cost of an increased false-positive rate (FPR). In incident screening rounds, a lower cancer detection rate (CDR) is expected due to a smaller pool of prevalent cancers, and a reduced FPR, due to the availability of prior MRI examinations. Purpose To investigate screening performance indicators of the second round (incidence round) of the DENSE trial. Materials and Methods The DENSE trial (ClinicalTrials.gov: NCT01315015) is embedded within the Dutch population-based biennial mammography screening program for women aged 50-75 years. MRI examinations were performed between December 2011 and January 2016. Women were eligible for the second round when they again had a negative screening mammogram 2 years after their first MRI. The recall rate, biopsy rate, CDR, FPR, positive predictive values, and distributions of tumor characteristics were calculated and compared with results of the first round using 95% CIs and χ tests. Results A total of 3436 women (median age, 56 years; interquartile range, 48-64 years) underwent a second MRI screening. The CDR was 5.8 per 1000 screening examinations (95% CI: 3.8, 9.0) compared with 16.5 per 1000 screening examinations (95% CI: 13.3, 20.5) in the first round. The FPR was 26.3 per 1000 screening examinations (95% CI: 21.5, 32.3) in the second round versus 79.8 per 1000 screening examinations (95% CI: 72.4, 87.9) in the first round. The positive predictive value for recall was 18% (20 of 110 participants recalled; 95% CI: 12.1, 26.4), and the positive predictive value for biopsy was 24% (20 of 84 participants who underwent biopsy; 95% CI: 16.0, 33.9), both comparable to that of the first round. All tumors in the second round were stage 0-I and node negative. Conclusion The incremental cancer detection rate in the second round was 5.8 per 1000 screening examinations-compared with 16.5 per 1000 screening examinations in the first round. This was accompanied by a strong reduction in the number of false-positive results. © RSNA, 2021 See also the editorial by Moy and Gao in this issue.
背景 在 DENSE 试验的第一轮（普遍）补充 MRI 筛查中，尽管假阳性率（FPR）增加，但发现了相当数量的乳腺癌。在偶发筛查中，由于普遍存在的癌症数量减少，以及由于可获得先前的 MRI 检查，FPR 降低，预计癌症检出率（CDR）会降低。目的 探讨 DENSE 试验第二轮（偶发轮）的筛查性能指标。材料与方法 DENSE 试验（ClinicalTrials.gov：NCT01315015）嵌入在荷兰针对 50-75 岁女性的基于人群的两年一次乳腺 X 线筛查计划中。MRI 检查于 2011 年 12 月至 2016 年 1 月进行。当女性在第一次 MRI 后 2 年再次进行阴性筛查乳房 X 线摄影时，有资格参加第二轮。使用 95%CI 和 χ 检验，计算和比较第二轮的召回率、活检率、CDR、FPR、阳性预测值和肿瘤特征分布，并与第一轮的结果进行比较。结果 共有 3436 名女性（中位年龄为 56 岁；四分位距，48-64 岁）接受了第二轮 MRI 筛查。与第一轮每 1000 次筛查检查中 16.5 例（95%CI：13.3，20.5）相比，第二轮每 1000 次筛查检查中 CDR 为 5.8 例（95%CI：3.8，9.0）。第二轮的 FPR 为每 1000 次筛查检查 26.3（95%CI：21.5，32.3），而第一轮为每 1000 次筛查检查 79.8（95%CI：72.4，87.9）。召回的阳性预测值为 18%（20 名被召回的参与者；95%CI：12.1，26.4），活检的阳性预测值为 24%（84 名接受活检的参与者；95%CI：16.0，33.9），均与第一轮相似。第二轮的所有肿瘤均为 0-I 期和淋巴结阴性。结论 第二轮的增量癌症检出率为每 1000 次筛查检查 5.8 例，与第一轮每 1000 次筛查检查 16.5 例相比有所增加。这伴随着假阳性结果数量的大幅减少。©RSNA，2021 还请参见本期 Moy 和 Gao 的社论。
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