Singh Puneet, Scoggins Marion E, Sahin Aysegul A, Hwang Rosa F, Kuerer Henry M, Caudle Abigail S, Mittendorf Elizabeth A, Thompson Alastair M, Bedrosian Isabelle, Teshome Mediget, DeSnyder Sarah M, Meric-Bernstam Funda, Hunt Kelly K
Department of Breast Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.
Department of Breast Imaging, The University of Texas MD Anderson Cancer Center, Houston, TX.
Ann Surg Open. 2020 Dec;1(2):e008. doi: 10.1097/as9.0000000000000008.
A prospective, phase IV study was conducted to assess the effectiveness of Magseed to localize breast lesions requiring surgical excision.
Since FDA approval in 2016, Magseed has been increasingly used to localize non-palpable lesions due to advantages over wires or radioactive seeds. This is the first prospective, post marketing trial of Magseed.
From 1/2017-2/2018, 107 women with lesions requiring localization were enrolled at a single institution. Primary endpoint was Magseed retrieval rate. Secondary endpoints were adverse events, accuracy of placement, surgery duration and positive margin rate. Clinicians were surveyed for ease of use using a Likert scale. Descriptive statistics and Fisher's exact test were performed to assess univariable associations with positive margins.
There were 124 Magseeds placed including one marker in 93 subjects, 2 markers in 11 and 3 markers in 3. The majority of lesions were masses (63%) followed by calcifications (24%). All 124 Magseeds were placed within 10mm of the target lesion and surgically retrieved with median operative time of 15min (range 4-47). No device-related adverse events occurred. Of the 98 malignant lesions, 9 had positive margins and 7 of them underwent a second surgery for additional margins. On univariable analysis, age ≤ 50 (25.0% vs 6.4%, =0.04), lesion histology ( = 0.03), and pathologic T-stage ( = 0.04) were significantly associated with positive margins. Clinicians rated the Magseed very or fairly easy to use in most cases.
The Magseed system for localization of non-palpable lesions was effective and safe; all markers were successfully retrieved with margin-negative resections in 91%. This study supports use of Magseed for localization of breast lesions.
开展一项前瞻性IV期研究，以评估Magseed用于定位需要手术切除的乳腺病变的有效性。
自2016年获得美国食品药品监督管理局（FDA）批准以来，由于Magseed相对于金属丝或放射性种子具有优势，其已越来越多地用于定位不可触及的病变。这是Magseed首次进行的前瞻性上市后试验。
2017年1月至2018年2月，一家机构招募了107例需要进行定位的病变女性患者。主要终点是Magseed取出率。次要终点是不良事件、放置准确性、手术持续时间和切缘阳性率。使用李克特量表对临床医生进行易用性调查。进行描述性统计和费舍尔精确检验以评估与切缘阳性的单变量关联。
共放置了124个Magseed，其中93例患者放置1个标记物，11例患者放置2个标记物，3例患者放置3个标记物。大多数病变为肿块（63%），其次为钙化灶（24%）。所有124个Magseed均放置在距目标病变10mm范围内，并通过手术取出，中位手术时间为15分钟（范围4 - 47分钟）。未发生与器械相关的不良事件。在98例恶性病变中，9例切缘阳性，其中7例因切缘问题接受了二次手术。单变量分析显示，年龄≤50岁（25.0%对6.4%，P = 0.04）、病变组织学（P = 0.03）和病理T分期（P = 0.04）与切缘阳性显著相关。临床医生在大多数情况下对Magseed的易用性评价为非常或相当容易。
用于定位不可触及病变的Magseed系统有效且安全；91%的标记物在切缘阴性切除时成功取出。本研究支持使用Magseed定位乳腺病变。
