Radioactive Seed Localization or Wire-guided Localization of Nonpalpable Invasive and In Situ Breast Cancer A Randomized, Multicenter, Open-label Trial
Radioactive Seed Localization or Wire-guided Localization of Nonpalpable Invasive and In Situ Breast Cancer A Randomized, Multicenter, Open-label Trial
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DOI：
10.1097/sla.0000000000002101
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发表时间：
2017-07-01
影响因子：
9
通讯作者：
Kroman, Niels
中科院分区：
文献类型：
--
作者：
Langhans, Linnea;Tvedskov, Tove F.;Kroman, Niels
目的：比较放射性粒子定位（RSL）与导丝定位（WGL）在保乳手术（BCS）后的切缘阳性率。背景：WGL是目前BCS中不可扪及乳腺病灶定位的标准，但该方法存在一些困难。方法：2014年1月1日至2016年2月4日，纳入超声可见不可扪及浸润性乳腺癌或导管原位癌（DCIS）患者。这项随机、多中心、开放标签临床试验，并随机分配至 RSL 或 WGL。主要结局是 BCS 后的边缘状态。次要结果是手术过程的持续时间、手术标本的重量和患者的疼痛感知。根据意向治疗 (ITT) 和方案进行分析。 结果：在 444 名符合条件的患者中，代表 409 名患者的 413 个病变被随机分组； 207 至 RSL，206 至 WGL。 23 名不符合纳入标准、选择退出或改变手术治疗而被排除。其余 390 个病变构成 ITT 群体。其中，RSL 组中有 23 例（11.8%）切除切缘呈阳性，而 WGL 组中有 26 例（13.3%）呈阳性（P = 0.65）。按方案分析显示边缘状态没有差异 (P = 0.62)。手术时间 (P = 0.12)、手术标本重量 (P = 0.54) 或患者的疼痛感知 (P = 0.28) 没有显着差异。 结论：RSL 具有重大的后勤优势，因为与 WGL 相比，可以在手术前几天进行定位，且不会增加阳性切除边缘。
Objective: To compare the rate of positive resection margins between radioactive seed localization (RSL) and wire-guided localization (WGL) after breast conserving surgery (BCS).Background: WGL is the current standard for localization of nonpalpable breast lesions in BCS, but there are several difficulties related to the method.Methods: From January 1, 2014 to February 4, 2016, patients with nonpalpable invasive breast cancer or DCIS visible on ultrasound were enrolled in this randomized, multicenter, open-label clinical trial, and randomly assigned to RSL or WGL. The primary outcome was margin status after BCS. Secondary outcomes were duration of the surgical procedure, weight of surgical specimen, and patients' pain perception. Analyses were performed by intention-to-treat (ITT) and per protocol.Results: Out of 444 eligible patients, 413 lesions representing 409 patients were randomized; 207 to RSL and 206 to WGL. Twenty-three did not meet inclusion criteria, chose to withdraw, or had a change in surgical management and were excluded. The remaining 390 lesions constituted the ITT population. Here, resection margins were positive in 23 cases (11.8%) in the RSL group compared with 26 cases (13.3%) in the WGL group (P = 0.65). The per-protocol analysis revealed no difference in margin status (P = 0.62). There were no significant differences in the duration of the surgical procedure (P = 0.12), weight of the surgical specimen (P = 0.54) or the patients' pain perception (P = 0.28).Conclusion: RSL offers a major logistic advantage, as localization can be done several days before surgery without any increase in positive resection margins compared with WGL.