临床腋窝淋巴结阴性的可手术乳腺癌女性患者前哨淋巴结活检与低位腋窝取样的比较

Sentinel node biopsy versus low axillary sampling in women with clinically node negative operable breast cancer.

作者信息

Parmar V, Hawaldar R, Nair N S, Shet T, Vanmali V, Desai S, Gupta S, Rangrajan V, Mittra I, Badwe R A

机构信息

Breast Unit, Department of Surgical Oncology, Breast Cancer Working Group, Tata Memorial Centre, Mumbai, India.

出版信息

Breast. 2013 Dec;22(6):1081-6. doi: 10.1016/j.breast.2013.06.006. Epub 2013 Aug 13.

DOI:10.1016/j.breast.2013.06.006

PMID:23948301

Abstract

BACKGROUND

Sentinel node biopsy (SNB) was initially conceived as excision of the first station axillary lymph node(s) (LN) identified by radioactive and/or blue dye uptake. The definition was subsequently enlarged to also include palpable lymph nodes in the vicinity of sentinel node(s) (SN). We reasoned that the excision of this combination of nodes might be best achieved by sampling the lower axilla.

METHODS

Each patient underwent low axillary sampling (LAS) and identification of SN in the excised specimen followed by complete axillary lymph node dissection (ALND). LAS was defined as excision of all fibrofatty tissue overlying the second digitation of serratus anterior below the intercostobrachial nerve and was carried out following a pre-operative injection of radioactive colloid and an intra-operative injection of blue dye. Blue and/or hot nodes (B&/HN) in the dissected tissue and remaining axilla, along with any palpable nodes within the sampled tissue, were defined as SN. The primary endpoint of the study was to compare false negative rates (FNR) of SN with that of LAS in predicting axillary LN status (NCT00128362).

FINDINGS

The study was performed between March 2004 and December 2011 in 478 women with clinically node negative axilla. On histopathological evaluation the median tumor size was 2.5 cm and axillary nodal metastases were found in 34.1% of patients. The FNR of SNB (12.7%, 95% CI 8.1-19.4) and LAS (10.5%, 95% CI 6.6-16.2) were not significantly different (p = 0.56). The FNR of B&/HN alone, without palpable nodes, (29.0%, 95% CI 22.5-36.6) was significantly inferior to those of SNB (p = 0.0007) and LAS (p = 0.0003).

INTERPRETATION

LAS is as accurate as SNB in predicting axillary LN status in women with clinically node negative operable breast cancer. Confining SNB procedure to excision of B&/HN, significantly increases the risk of leaving behind metastatic lymph nodes in the axilla. LAS is an effective and low cost procedure that minimizes axillary surgery and can be implemented widely. Registry Name: Clinicaltrials.gov.

REGISTRATION NUMBER

NCT00128362.

摘要

背景

前哨淋巴结活检（SNB）最初被设想为切除通过放射性和/或蓝色染料摄取确定的第一站腋窝淋巴结。随后该定义扩大到也包括前哨淋巴结（SN）附近可触及的淋巴结。我们推断，通过对腋窝下部进行采样可能最好地实现对这种淋巴结组合的切除。

方法

每位患者均接受腋窝下部采样（LAS），并在切除标本中识别SN，随后进行腋窝淋巴结清扫术（ALND）。LAS定义为切除肋间臂神经下方前锯肌第二肌齿上方的所有纤维脂肪组织，在术前注射放射性胶体和术中注射蓝色染料后进行。解剖组织和剩余腋窝中的蓝色和/或热结节（B&/HN）以及采样组织内任何可触及的结节被定义为SN。该研究的主要终点是比较SN和LAS在预测腋窝淋巴结状态方面的假阴性率（FNR）（NCT00128362）。

研究结果

该研究于2004年3月至2011年12月在478例临床腋窝淋巴结阴性的女性中进行。经组织病理学评估，肿瘤中位大小为2.5厘米，34.1%的患者发现腋窝淋巴结转移。SNB的FNR（12.7%，95%CI 8.1 - 19.4）和LAS的FNR（10.5%，95%CI 6.6 - 16.2）无显著差异（p = 0.56）。仅B&/HN且无可触及结节的FNR（29.0%，95%CI 22.5 - 36.6）显著低于SNB（p = 0.0007）和LAS（p = 0.0003）。