A randomized comparison of sentinel-node biopsy with routine axillary dissection in breast cancer

A randomized comparison of sentinel-node biopsy with routine axillary dissection in breast cancer
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DOI:
10.1056/nejmoa012782
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发表时间:
2003-08-07
影响因子:
158.5
通讯作者:
Gennari, R
Gennari, R
中科院分区:
医学1区
文献类型:
--
作者:
Veronesi, U;Paganelli, G;Gennari, R

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背景:虽然大量研究表明前哨淋巴结状态是乳腺癌腋窝淋巴结状态的准确预测指标,但前哨淋巴结活检的有效性和安全性尚需验证。方法:1998年3月至1999年12月,我们随机将516例直径小于或等于2 cm的乳腺癌患者随机分为前哨淋巴结活检加全腋窝清扫组(腋窝清扫组)或前哨淋巴结活检后腋窝清扫组(前哨结组)。结果:两组发现的前哨淋巴结数目相同。腋窝清扫组257例患者中83例前哨淋巴结阳性(32.3%),前哨结组259例患者中92例前哨淋巴结阳性(35.5%)。腋窝清扫组判断前哨淋巴结状态的总体准确率为96.9%,敏感度为91.2%,特异度为100%。仅接受前哨淋巴结活检的患者比同时接受腋窝清扫的患者疼痛更少,手臂活动能力更好。腋窝清扫组有15例与乳腺癌相关的事件,前哨结组有10例此类事件。在167例未行腋窝清扫的患者中,随访期间没有发现明显的腋窝转移。结论:前哨淋巴结活检是一种安全、准确的筛查小乳腺癌腋窝淋巴结转移的方法。
BACKGROUND:Although numerous studies have shown that the status of the sentinel node is an accurate predictor of the status of the axillary nodes in breast cancer, the efficacy and safety of sentinel-node biopsy require validation.METHODS:From March 1998 to December 1999, we randomly assigned 516 patients with primary breast cancer in whom the tumor was less than or equal to 2 cm in diameter either to sentinel-node biopsy and total axillary dissection (the axillary-dissection group) or to sentinel-node biopsy followed by axillary dissection only if the sentinel node contained metastases (the sentinel-node group).RESULTS:The number of sentinel nodes found was the same in the two groups. A sentinel node was positive in 83 of the 257 patients in the axillary-dissection group (32.3 percent), and in 92 of the 259 patients in the sentinel-node group (35.5 percent). In the axillary-dissection group, the overall accuracy of the sentinel-node status was 96.9 percent, the sensitivity 91.2 percent, and the specificity 100 percent. There was less pain and better arm mobility in the patients who underwent sentinel-node biopsy only than in those who also underwent axillary dissection. There were 15 events associated with breast cancer in the axillary-dissection group and 10 such events in the sentinel-node group. Among the 167 patients who did not undergo axillary dissection, there were no cases of overt axillary metastasis during follow-up.CONCLUSIONS:Sentinel-node biopsy is a safe and accurate method of screening the axillary nodes for metastasis in women with a small breast cancer.