TY - JOUR

T1 - Radioactive Seed Localization or Wire-guided Localization of Nonpalpable Invasive and In Situ Breast Cancer A Randomized, Multicenter, Open-label Trial

AU - Langhans, Linnea

AU - Tvedskov, Tove F.

AU - Klausen, Thomas L.

AU - Jensen, Maj-Britt

AU - Talman, Maj-Lis

AU - Vejborg, Ilse

AU - Benian, Cemil

AU - Roslind, Anne

AU - Hermansen, Jonas

AU - Oturai, Peter S.

AU - Bentzon, Niels

AU - Kroman, Niels

PY - 2017/7

Y1 - 2017/7

N2 - 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.

AB - 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.

KW - breast conserving surgery

KW - ductal carcinoma in situ

KW - invasive breast cancer

KW - radioactive seed localization

KW - wire-guided localization

U2 - 10.1097/SLA.0000000000002101

DO - 10.1097/SLA.0000000000002101

M3 - Journal article

C2 - 28257326

VL - 266

SP - 29

EP - 35

JO - Advances in Surgery

JF - Advances in Surgery

SN - 0003-4932

IS - 1

ER -