Department of Surgery, Huntington Hospital, 100 W California Blvd, Pasadena, CA, 91105, USA.
Department of Clinical Research, Huntington Hospital, 100 W California Blvd, Pasadena, CA, 91105, USA.
Breast Cancer Res Treat. 2020 Aug;183(1):145-151. doi: 10.1007/s10549-020-05773-5. Epub 2020 Jul 1.
A positive margin after breast conserving surgery has consistently been shown to be a significant predictor for ipsilateral breast tumor recurrence. Currently, there is no standard for intraoperative margin assessment during lumpectomy, and up to 20% of cases result in positive margins. MarginProbe is a device that provides real-time evaluation of lumpectomy margins during surgery. The aim of this study was to evaluate the impact of MarginProbe as an adjunct to standard operating procedure (SOP).
Patients diagnosed with breast cancer scheduled for breast conserving surgery were consented for intraoperative use of MarginProbe. Shaved margins were excised based on margin assessment using the surgeon's SOP which included specimen radiography and gross pathologic examination, and feedback from the device. The primary endpoint was re-excision rate. Secondary endpoints included sensitivity, specificity, false-positive and negative rates.
Of the 60 breast cancers, initial histologically close/positive margins were identified in 18 patients (30%). The re-excision rate in the overall cohort was 6.6%, compared to a historical re-excision rate of 8.6% (p < 0.01). Based on 360 measurement sites, MarginProbe demonstrated a sensitivity of 67% and specificity of 60%, with a positive predictive value of 16%, and of negative predictive value of 94%, which was similar to the accuracy of SOP.
MarginProbe performs equally as well as specimen radiography and gross pathologic examination. In this setting where the baseline re-excision rate was low, the use of MarginProbe as an adjunct to SOP resulted in a small 2% absolute reduction in re-excision rate.
保乳手术后的阳性切缘一直是同侧乳房肿瘤复发的重要预测因素。目前，在保乳手术中没有术中切缘评估的标准，多达 20%的病例会出现阳性切缘。MarginProbe 是一种在手术过程中实时评估保乳手术切缘的设备。本研究旨在评估 MarginProbe 作为标准操作程序 (SOP) 的辅助手段的影响。
计划接受保乳手术的乳腺癌患者同意在手术中使用 MarginProbe。根据 MarginProbe 提供的手术医生 SOP（包括标本 X 光和大体病理检查以及设备反馈）进行切缘评估，切除切缘。主要终点是再次切除率。次要终点包括敏感性、特异性、假阳性和假阴性率。
在 60 例乳腺癌中，18 例（30%）患者最初的组织学切缘为接近阳性或阳性。整个队列的再次切除率为 6.6%，而历史再次切除率为 8.6%（p<0.01）。根据 360 个测量点，MarginProbe 的敏感性为 67%，特异性为 60%，阳性预测值为 16%，阴性预测值为 94%，与 SOP 的准确性相似。
MarginProbe 的性能与标本 X 光和大体病理检查相当。在这种背景下，基线再次切除率较低，使用 MarginProbe 作为 SOP 的辅助手段可使再次切除率绝对降低 2%。
