Clanahan Julie M, Reddy Sanjana, Broach Robyn B, Rositch Anne F, Anderson Benjamin O, Wileyto E Paul, Englander Brian S, Brooks Ari D
Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.
Department of Surgery, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.
JCO Glob Oncol. 2020 Feb;6:27-34. doi: 10.1200/JGO.19.00205.
Globally, breast cancer represents the most common cause of cancer death among women. Early cancer diagnosis is difficult in low- and middle-income countries, most of which are unable to support population-based mammographic screening. Triage on the basis of clinical breast examination (CBE) alone can be difficult to implement. In contrast, piezo-electric palpation (intelligent Breast Exam [iBE]) may improve triage because it is portable, low cost, has a short learning curve, and provides electronic documentation for additional diagnostic workup. We compared iBE and CBE performance in a screening patient cohort from a Western mammography center.
Women presenting for screening or diagnostic workup were enrolled and underwent iBE then CBE, followed by mammography. Mammography was classified as negative (BI-RADS 1 or 2) or positive (BI-RADS 3, 4, or 5). Measures of accuracy and κ score were calculated.
Between April 2015 and May 2017, 516 women were enrolled. Of these patients, 486 completed iBE, CBE, and mammography. There were 101 positive iBE results, 66 positive CBE results, and 35 positive mammograms. iBE and CBE demonstrated moderate agreement on categorization (κ = 0.53), but minimal agreement with mammography (κ = 0.08). iBE had a specificity of 80.3% and a negative predictive value of 94%. In this cohort, only five of 486 patients had a malignancy; iBE and CBE identified three of these five. The two cancers missed by both modalities were small-a 3-mm retro-areolar and a 1-cm axillary tail.
iBE performs comparably to CBE as a triage tool. Only minimal cancers detected through mammographic screening were missed on iBE. Ultimately, our data suggest that iBE and CBE can synergize as triage tools to significantly reduce the numbers of patients who need additional diagnostic imaging in resource-limited areas.
在全球范围内，乳腺癌是女性癌症死亡的最常见原因。在低收入和中等收入国家，早期癌症诊断很困难，其中大多数国家无法支持基于人群的乳房X光筛查。仅基于临床乳房检查（CBE）进行分流可能难以实施。相比之下，压电触诊（智能乳房检查[iBE]）可能会改善分流，因为它便于携带、成本低、学习曲线短，并可为进一步的诊断检查提供电子文档。我们比较了西方乳房X光检查中心筛查患者队列中iBE和CBE的性能。
纳入前来进行筛查或诊断检查的女性，先进行iBE检查，然后进行CBE检查，随后进行乳房X光检查。乳房X光检查分为阴性（BI-RADS 1或2）或阳性（BI-RADS 3、4或5）。计算准确性和κ评分指标。
2015年4月至2017年5月期间，共纳入516名女性。其中486名患者完成了iBE、CBE和乳房X光检查。iBE检查结果阳性101例，CBE检查结果阳性66例，乳房X光检查结果阳性35例。iBE和CBE在分类上显示出中度一致性（κ = 0.53），但与乳房X光检查的一致性极小（κ = 0.08）。iBE的特异性为80.3%，阴性预测值为94%。在该队列中，486名患者中只有5例患有恶性肿瘤；iBE和CBE识别出了这5例中的3例。两种检查方式均漏诊的两例癌症较小，一例为3毫米乳晕后癌，另一例为1厘米腋窝尾部癌。
作为一种分流工具，iBE的性能与CBE相当。通过乳房X光筛查检测到的极小癌症在iBE检查中被漏诊。最终，我们的数据表明，iBE和CBE可作为分流工具协同作用，以显著减少资源有限地区需要额外诊断性影像学检查的患者数量。
