Department of Radiology, Mayo Clinic in Arizona, Phoenix, AZ.
Department of Medical Oncology, Mayo Clinic in Arizona, Phoenix, AZ.
J Clin Oncol. 2024 Nov 10;42(32):3826-3836. doi: 10.1200/JCO.22.02819. Epub 2024 Jul 26.
Contrast-enhanced mammography (CEM) and magnetic resonance imaging (MRI) have shown similar diagnostic performance in detection of breast cancer. Limited CEM data are available for high-risk breast cancer screening. The purpose of the study was to prospectively investigate the efficacy of supplemental screening CEM in elevated risk patients.
A prospective, single-institution, institutional review board-approved observational study was conducted in asymptomatic elevated risk women age 35 years or older who had a negative conventional two-dimensional digital breast tomosynthesis screening mammography (MG) and no additional supplemental screening within the prior 12 months.
Four hundred sixty women were enrolled from February 2019 to April 2021. The median age was 56.8 (range, 35.0-79.2) years; 408 of 460 (88.7%) were mammographically dense. Biopsy revealed benign changes in 22 women (22/37, 59%), high-risk lesions in four women (4/37, 11%), and breast cancer in 11 women (11/37, 30%). Fourteen cancers (10 invasive, tumor size range 4-15 mm, median 9 mm) were diagnosed in 11 women. The overall supplemental cancer detection rate was 23.9 per 1,000 patients, 95% CI (12.0 to 42.4). All cancers were grade 1 or 2, ER+ ERBB2-, and node negative. CEM imaging screening offered high specificity (0.875 [95% CI, 0.844 to 0.906]), high NPV (0.998 [95% CI, 0.993 to 1.000), moderate PPV1 (0.164 [95% CI, 0.076 to 0.253), moderate PPV3 (0.275 [95% CI, 0.137 to 0.413]), and high sensitivity (0.917 [95% CI, 0.760 to 1.000]). At least 1 year of imaging follow-up was available on all patients, and one interval cancer was detected on breast MRI 4 months after negative screening CEM.
A pilot trial demonstrates a supplemental cancer detection rate of 23.9 per 1,000 in women at an elevated risk for breast cancer. Larger, multi-institutional, multiyear CEM trials in patients at elevated risk are needed for validation.
对比增强乳腺摄影术（CEM）和磁共振成像（MRI）在乳腺癌检测中的诊断性能相似。目前针对高危乳腺癌筛查的 CEM 数据有限。本研究旨在前瞻性研究补充 CEM 在高危患者中的筛查效果。
这是一项在无症状高危女性中进行的前瞻性、单中心、机构审查委员会批准的观察性研究，这些女性年龄在 35 岁及以上，接受了阴性常规二维数字乳腺断层合成筛查乳房 X 线摄影术（MG），且在过去 12 个月内没有进行任何额外的补充筛查。
2019 年 2 月至 2021 年 4 月共纳入 460 名女性。中位年龄为 56.8（范围：35.0-79.2）岁；460 名女性中有 408 名（88.7%）乳腺呈致密性。22 名女性（22/37，59%）活检显示良性改变，4 名女性（4/37，11%）存在高风险病变，11 名女性（11/37，30%）诊断为乳腺癌。11 名女性中有 14 名癌症（10 名浸润性癌，肿瘤大小范围 4-15mm，中位值 9mm）。1000 名患者中有 23.9 例（95%CI，12.0-42.4）补充发现癌症，总体癌症检出率为 23.9/1000 例。所有癌症均为 1 级或 2 级，ER+、ERBB2-、且无淋巴结转移。CEM 成像筛查具有高特异性（0.875[95%CI，0.844 至 0.906]）、高阴性预测值（0.998[95%CI，0.993 至 1.000]）、中等阳性预测值 1（0.164[95%CI，0.076 至 0.253]）、中等阳性预测值 3（0.275[95%CI，0.137 至 0.413]）和高灵敏度（0.917[95%CI，0.760 至 1.000]）。所有患者均至少有 1 年的影像学随访，在阴性 CEM 筛查后 4 个月，乳腺 MRI 检测到 1 例间期癌。
该试验初步表明，高危乳腺癌女性中 CEM 补充检出率为 23.9/1000。需要在高危患者中进行更大规模、多机构、多年的 CEM 试验以验证该结果。
