Combined screening with ultrasound and mammography vs mammography alone in women at elevated risk of breast cancer
Combined screening with ultrasound and mammography vs mammography alone in women at elevated risk of breast cancer
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DOI：
10.1001/jama.299.18.2151
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发表时间：
2008-05-14
影响因子：
120.7
通讯作者：
Boparai, Karan
中科院分区：
文献类型：
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作者：
Berg, Wendie A.;Blume, Jeffrey D.;Boparai, Karan
背景超声筛查可以描述乳腺X线摄影未发现的小的、淋巴结阴性的乳腺癌。目的比较乳腺癌高风险妇女中超声筛查+乳腺X线摄影与单纯乳腺X线摄影的诊断率，定义为筛查阳性结果和阳性参考标准的妇女比例，以及超声筛查+乳腺X线摄影与单纯乳腺X线摄影的性能。从21个研究中心招募了2809名女性，她们在至少1个象限中具有至少不均匀致密的乳腺组织，由一名对其他检查结果不知情的放射科医生按随机顺序进行乳房X线摄影和医生进行的超声检查。参考标准被定义为病理学和12个月随访的组合，可用于2637例主要结果指标诊断率、敏感性、特异性，和诊断准确性（通过受试者工作特征曲线下面积评估）乳腺X线摄影加超声检查与单纯乳腺X线摄影的阳性预测值以及乳腺X线摄影加超声检查与单纯乳腺X线摄影的活检建议的阳性预测值。（41个乳房）被诊断为癌症：8个可疑的超声和乳房X光检查，12个仅超声检查，12个仅乳房X光检查，8个参与者（9个乳房）都没有。乳腺X线摄影的诊断率为7.6/1000（20/2637），乳腺X线摄影加超声的诊断率增加到11.8/1000（31/2637）;补充诊断率为4.2/1000（95%置信区间[ CI]，1.1- 7.2/1000; P= 0.001）。003补充收益率为0）。乳腺X线摄影的诊断准确性为0.78（95% CI，0.67- 0.87），乳腺X线摄影+超声的诊断准确性增加至0.91（95% CI，0.84- 0.96）（P=. 003这个差是0）。在12例仅通过超声检测到的补充性癌症中，11例（92%）为浸润性，中位尺寸为10 mm（范围，5- 40 mm;平均值[ SE]，12.6 [ 3.0] mm），报告的9个病灶中有8个（89%）有阴性淋巴结。完整诊断检查后活检建议的阳性预测值为乳腺X线摄影84例中的19例（22.6%; 95%CI，14.2%- 33%），超声235例中的21例（8.9%，95%CI，5.6%- 13.3%），乳腺X线摄影+超声联合检查276例中的31例（11.2%; 95%CI。7.8%- 15.6%）。结论在乳腺X线摄影中增加单一的超声筛查将使每1000名高危妇女增加1.1至7.2例癌症，但也会大大增加假阳性的数量。政府标识符：NCT 00072501。
Context Screening ultrasound may depict small, node- negative breast cancers not seen on mammography.Objective To compare the diagnostic yield, defined as the proportion of women with positive screen test results and positive reference standard, and performance of screening with ultrasound plus mammography vs mammography alone in women at elevated risk of breast cancer.Design, Setting, and Participants From April 2004 to February 2006, 2809 women, with at least heterogeneously dense breast tissue in at least 1 quadrant, were recruited from 21 sites to undergo mammographic and physician- performed ultrasonographic examinations in randomized order by a radiologist masked to the other examination results. Reference standard was defined as a combination of pathology and 12- month follow-up and was available for 2637 ( 96.8%) of the 2725 eligible participants.Main Outcome Measures Diagnostic yield, sensitivity, specificity, and diagnostic accuracy ( assessed by the area under the receiver operating characteristic curve) of combined mammography plus ultrasound vs mammography alone and the positive predictive value of biopsy recommendations for mammography plus ultrasound vs mammography alone.Results Forty participants ( 41 breasts) were diagnosed with cancer: 8 suspicious on both ultrasound and mammography, 12 on ultrasound alone, 12 on mammography alone, and 8 participants ( 9 breasts) on neither. The diagnostic yield for mammography was 7.6 per 1000 women screened ( 20 of 2637) and increased to 11.8 per 1000 ( 31 of 2637) for combined mammography plus ultrasound; the supplemental yield was 4.2 per 1000 women screened ( 95% confidence interval [ CI], 1.1- 7.2 per 1000; P=. 003 that supplemental yield is 0). The diagnostic accuracy for mammography was 0.78 ( 95% CI, 0.67- 0.87) and increased to 0.91 ( 95% CI, 0.84- 0.96) for mammography plus ultrasound ( P=. 003 that difference is 0). Of 12 supplemental cancers detected by ultrasound alone, 11 ( 92%) were invasive with a median size of 10 mm( range, 5- 40 mm; mean [ SE], 12.6 [ 3.0] mm) and 8 of the 9 lesions ( 89%) reported had negative nodes. The positive predictive value of biopsy recommendation after full diagnostic workup was 19 of 84 for mammography ( 22.6%; 95% CI, 14.2%- 33%), 21 of 235 for ultrasound ( 8.9%, 95% CI, 5.6%- 13.3%), and 31 of 276 for combined mammography plus ultrasound ( 11.2%; 95% CI. 7.8%- 15.6%).Conclusions Adding a single screening ultrasound to mammography will yield an additional 1.1 to 7.2 cancers per 1000 high- risk women, but it will also substantially increase the number of false positives.Trial Registration clinicaltrials. gov Identifier: NCT00072501.