Guangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.
Department of Breast Surgery, Breast Tumor Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China.
Ann Surg Oncol. 2019 Dec;26(13):4256-4263. doi: 10.1245/s10434-019-07725-w. Epub 2019 Aug 19.
This randomized controlled trial aimed to investigate the effects of circumferential shaving on reducing the intraoperative margin positivity rate (MPR) during breast-conserving surgery (BCS).
Eligible breast cancer patients were randomly assigned into no-shave and shave groups. In the no-shave group, the cavity margins were collected for assessment after the tumor resection, whereas in the shave group, a circumferential shaving was performed before collecting the cavity margins. The primary outcome was the intraoperative MPR by frozen section analysis.
A total of 181 patients, with a median age of 49 years, were randomized. Patient characteristics at baseline were well-balanced between the two groups. The intraoperative MPRs (12.1% vs. 7.8%, p = 0.38), postoperative MPRs (16.5% vs. 7.8%, p = 0.073), intraoperative re-excision rates (26.4% vs. 23.3%, p = 0.64), second operation rates (4.4% vs. 1.1%, p = 0.34), and successful BCS rate (93.4% vs. 94.4%, p = 0.94) were all similar between the no-shave and the shave groups. The volume of the shaved tissues was significantly increased in patients with larger breast volume (p < 0.01). In patients with C-E cup breasts, the no-shave and shave groups had 16.7% and 0% (p = 0.03) intraoperative MPRs, and 22.0% and 0% (p = 0.01) postoperative MPRs, respectively. In patients with A-B cup breasts, the MPRs were similar between the two groups. The presence of the ductal carcinoma in situ component is the only determinant of margin positivity.
Circumferential shaving did not significantly reduce the MPR in BCS. Its benefit depends on the volume of the shaved tissues and the breast. Trial registration This trial was registered at ClinicalTrials.gov (NCT02648802).
本随机对照试验旨在探讨环周 shave 对降低保乳手术（BCS）术中切缘阳性率（MPR）的影响。
将符合条件的乳腺癌患者随机分为不 shave 组和 shave 组。在不 shave 组中，在肿瘤切除后收集腔隙切缘进行评估，而在 shave 组中，在收集腔隙切缘前进行环周 shave。主要结局是通过冷冻切片分析的术中 MPR。
共纳入 181 例中位年龄为 49 岁的患者，随机分组。两组患者的基线特征均衡。术中 MPR（12.1% vs. 7.8%，p=0.38）、术后 MPR（16.5% vs. 7.8%，p=0.073）、术中再次切除率（26.4% vs. 23.3%，p=0.64）、二次手术率（4.4% vs. 1.1%，p=0.34）和成功的 BCS 率（93.4% vs. 94.4%，p=0.94）在不 shave 组和 shave 组之间均相似。乳房体积较大的患者 shave 组织的体积明显增加（p<0.01）。在 C-E 罩杯的患者中，不 shave 组和 shave 组的术中 MPR 分别为 16.7%和 0%（p=0.03），术后 MPR 分别为 22.0%和 0%（p=0.01）。在 A-B 罩杯的患者中，两组之间的 MPR 相似。导管原位癌成分的存在是切缘阳性的唯一决定因素。
环周 shave 并不能显著降低 BCS 中的 MPR。其获益取决于 shave 组织的体积和乳房的大小。
本试验在 ClinicalTrials.gov 注册（NCT02648802）。
