Department of Surgery, Canisius Wilhelmina Hospital, Weg door Jonkerbos 100, 6532 SB, Nijmegen, The Netherlands.
Department of Radiology, Canisius Wilhelmina Hospital, Weg Door Jonkerbos 100, 6532 SB, Nijmegen, The Netherlands.
Breast Cancer Res Treat. 2017 Dec;166(3):669-679. doi: 10.1007/s10549-017-4475-2. Epub 2017 Aug 22.
Reducing positive margin rate (PMR) and reoperation rate in breast-conserving operations remains a challenge, mainly regarding ductal carcinoma in situ (DCIS). Intra-operative margin assessment tools have emerged to reduce PMR over the last decades, including specimen radiography (SR). No consensus has been reached on the reliability and efficacy of SR in DCIS.
We performed a systematic literature review to assess the performance characteristics of SR for margin assessment of breast lesions with pure DCIS and invasive cancers with DCIS components.
A literature search was conducted for diagnostic studies up to April 2017 concerning SR for intra-operative margin assessment of breast lesions with pure DCIS or with DCIS components. Studies reporting sensitivity and specificity calculated using final pathology report as reference test were included. Due to improved imaging technology, studies published more than 15 years ago were excluded. Methodological quality was assessed using quality assessment of diagnostic accuracy studies-2 checklist. Due to clinical and methodological diversity, meta-analysis was considered not useful.
Of 235 citations identified, 9 met predefined inclusion criteria and documented diagnostic efficacy data. Sensitivity ranged from 22 to 77% and specificity ranged from 51 to 100%. Positive predictive value and negative predictive value ranged from 53 to 100% and 32 to 95%, respectively. High or unclear risk of bias was found in reference standard in 5 of 9 studies. High concerns regarding applicability of index test were found in 6 of 9 studies.
The present results do not support the routine use of intra-operative specimen radiography to reduce the rate of positive margins in patients undergoing breast-conserving surgery for pure DCIS or the DCIS component in invasive cancer. Future studies need to differentiate between initial and final specimen margin involvement. This could provide surgeons with a number needed to treat for a more applicable outcome.
降低保乳手术中的切缘阳性率（PMR）和再次手术率仍然是一个挑战，尤其是对于导管原位癌（DCIS）。在过去几十年中，出现了一些术中切缘评估工具来降低 PMR，其中包括标本放射照相术（SR）。目前还没有达成关于 SR 在 DCIS 中的可靠性和有效性的共识。
我们进行了一项系统的文献回顾，以评估 SR 在评估纯 DCIS 和有 DCIS 成分的浸润性癌的乳腺病变的切缘中的性能特征。
对截至 2017 年 4 月的关于 SR 用于评估纯 DCIS 或有 DCIS 成分的乳腺病变的术中切缘的诊断研究进行了文献检索。纳入了报告使用最终病理报告作为参考标准计算出的敏感度和特异度的研究。由于成像技术的改进，排除了发表时间超过 15 年的研究。使用诊断准确性研究质量评估-2 清单评估了方法学质量。由于临床和方法学的多样性，认为不适合进行荟萃分析。
在 235 条引用中，有 9 条符合预定义的纳入标准，并记录了诊断功效数据。敏感度范围为 22%至 77%，特异度范围为 51%至 100%。阳性预测值和阴性预测值分别为 53%至 100%和 32%至 95%。在 9 项研究中的 5 项中，参考标准存在高或不确定的偏倚风险。在 9 项研究中的 6 项中，对该指数检验的适用性存在高度关注。
目前的结果不支持在进行保乳手术的患者中常规使用术中标本放射照相术来降低单纯 DCIS 或浸润性癌中的 DCIS 成分的切缘阳性率。未来的研究需要区分初始和最终标本边缘受累。这可以为外科医生提供一个更实用的治疗效果所需的人数。
