A Randomized, Controlled Trial of Cavity Shave Margins in Breast Cancer.
A Randomized, Controlled Trial of Cavity Shave Margins in Breast Cancer.
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DOI：
10.1056/nejmoa1504473
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发表时间：
2015-08-06
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影响因子：
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通讯作者：
Horowitz NR
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作者：
Chagpar AB;Killelea BK;Tsangaris TN;Butler M;Stavris K;Li F;Yao X;Bossuyt V;Harigopal M;Lannin DR;Pusztai L;Horowitz NR
常规切除空腔边缘（部分乳房切除术后留下的空腔周围的额外组织）可能会降低接受部分乳房切除术的乳腺癌患者的阳性边缘（肿瘤边缘阳性）和再切除率。在这项随机对照试验中，我们以1:1的比例分配了235名接受部分乳房切除术的0至III期乳腺癌患者，切除或不切除选择性边缘，进一步切除空腔边缘（切除组）或不进一步切除空腔边缘（不切除组）。随机化发生在手术完成标准乳房部分切除术后的术中。阳性边缘定义为浸润性癌时肿瘤与切除标本边缘接触，导管原位癌时肿瘤与切除标本边缘1mm内。阳性边缘率是主要结局指标；次要结果测量包括美容和切除组织的体积。患者的中位年龄为61岁（范围33 - 94岁）。在最终病理检查中，54例（23%）为浸润性癌，45例（19%）为导管原位癌，125例（53%）两者兼有；11例患者无进一步疾病。浸润性癌患者肿瘤最大直径中位数为1.1 cm（范围0 ~ 6.5），导管原位癌患者肿瘤最大直径中位数为1.0 cm（范围0 ~ 9.3）。在人口统计学和临床病理特征方面，各组在基线时匹配良好。乳房部分切除术后（随机化前），剃须组和未剃须组的阳性切缘率相似（分别为36%和34%；P= 0.69）。随机分组后，剃须组患者的阳性切缘率明显低于未剃须组（19% vs. 34%， P= 0.01），第二次手术切缘清除率也较低（10% vs. 21%， P= 0.02）。两组患者并发症发生率无显著差异。在部分乳房切除术患者中，刮除腔使阳性边缘和再切除率减半。（由耶鲁癌症中心资助；ClinicalTrials.gov编号：NCT01452399。）
Routine resection of cavity shave margins (additional tissue circumferentially around the cavity left by partial mastectomy) may reduce the rates of positive margins (margins positive for tumor) and reexcision among patients undergoing partial mastectomy for breast cancer. In this randomized, controlled trial, we assigned, in a 1:1 ratio, 235 patients with breast cancer of stage 0 to III who were undergoing partial mastectomy, with or without resection of selective margins, to have further cavity shave margins resected (shave group) or not to have further cavity shave margins resected (no-shave group). Randomization occurred intraoperatively after surgeons had completed standard partial mastectomy. Positive margins were defined as tumor touching the edge of the specimen that was removed in the case of invasive cancer and tumor that was within 1 mm of the edge of the specimen removed in the case of ductal carcinoma in situ. The rate of positive margins was the primary outcome measure; secondary outcome measures included cosmesis and the volume of tissue resected. The median age of the patients was 61 years (range, 33 to 94). On final pathological testing, 54 patients (23%) had invasive cancer, 45 (19%) had ductal carcinoma in situ, and 125 (53%) had both; 11 patients had no further disease. The median size of the tumor in the greatest diameter was 1.1 cm (range, 0 to 6.5) in patients with invasive carcinoma and 1.0 cm (range, 0 to 9.3) in patients with ductal carcinoma in situ. Groups were well matched at baseline with respect to demographic and clinicopathological characteristics. The rate of positive margins after partial mastectomy (before randomization) was similar in the shave group and the no-shave group (36% and 34%, respectively; P= 0.69). After randomization, patients in the shave group had a significantly lower rate of positive margins than did those in the no-shave group (19% vs. 34%, P= 0.01), as well as a lower rate of second surgery for margin clearance (10% vs. 21%, P= 0.02). There was no significant difference in complications between the two groups. Cavity shaving halved the rates of positive margins and reexcision among patients with partial mastectomy. (Funded by the Yale Cancer Center; ClinicalTrials.gov number, NCT01452399.)