Goyal Amit, Newcombe Robert G, Chhabra Alok, Mansel Robert E
Department of Surgery, Wales College of Medicine, Cardiff University, Cardiff, United Kingdom.
Breast Cancer Res Treat. 2006 Sep;99(2):203-8. doi: 10.1007/s10549-006-9192-1. Epub 2006 Mar 16.
Despite the widespread application of sentinel lymph node biopsy (SLNB) for early stage breast cancer, there is a wide variation in reported test performance characteristics. A major aim of this prospective multicentre validation study was to quantify detection and false-negative rates of SLNB and evaluate factors influencing them.
Eight-hundred and fourty-two patients with clinically node-negative breast cancer underwent SLNB according to a standardised protocol that used a combination of radiopharmaceutical 99mTc-albumin colloid and Patent Blue V dye. SLNB was followed by standard axillary treatment at the same operation in all patients.
Sentinel lymph nodes (SLNs) were identified in 803 (96.1%) of 836 evaluable cases. The median number of SLNs removed per patient was 2 (range 1-9). There were 19 false negatives, resulting in a sensitivity of 263/282 (93.3%) and accuracy 782/803 (97.6%). SLNs were successfully identified by blue dye in 698 (85.6%), by isotope in 698 (85.6%), and by the combination of blue dye and isotope in 782 (96.0%) of 815 patients. Among 276 node positive patients, one or more positive SLNs were identified by blue dye in 251 (90.9%), by isotope in 246 (89.1%) and by the combination of blue dye and gamma probe in 258 (93.5%). Obesity, tumor location other than upper outer quadrant and non-visualisation of SLNs on the pre-operative lymphoscintiscan were significantly associated with failed localisation (p<0.001, p=0.008, p<0.001, respectively). The false-negative rate in patients with grade 3 tumors was 9.6%, compared with 4.7% in those with grade 2 tumors (p=0.022). The false-negative rate in patients who had one SLN harvested was 10.1%, compared with 1.1% in those who had multiple SLNs (three or more) removed (p=0.010).
SLNB can accurately determine whether axillary metastases are present in patients with early stage breast cancer with clinically negative axillary nodes. Both success and accuracy of SLNB are optimised by the combined use of blue dye and isotope. SLNB success decreases with increasing body mass, tumor location other than the upper outer quadrant and non-visualisation of hot nodes on the pre-operative lymphoscintiscan. This study demonstrates reduction in the predictive value of a negative SLNB in grade 3 tumors.
尽管前哨淋巴结活检（SLNB）在早期乳腺癌中广泛应用，但报告的检测性能特征差异很大。这项前瞻性多中心验证研究的主要目的是量化SLNB的检测率和假阴性率，并评估影响它们的因素。
842例临床腋窝淋巴结阴性的乳腺癌患者按照标准化方案接受SLNB，该方案联合使用放射性药物99mTc-白蛋白胶体和专利蓝V染料。所有患者在同一手术中进行SLNB后接受标准腋窝治疗。
在836例可评估病例中，803例（96.1%）发现了前哨淋巴结（SLN）。每位患者切除的SLN中位数为2个（范围1-9个）。有19例假阴性，灵敏度为263/282（93.3%），准确率为782/803（97.6%）。在815例患者中，698例（85.6%）通过蓝色染料成功识别SLN，698例（85.6%）通过同位素成功识别，782例（96.0%）通过蓝色染料和同位素联合成功识别。在276例腋窝淋巴结阳性患者中，251例（90.9%）通过蓝色染料识别出一个或多个阳性SLN，246例（89.1%）通过同位素识别，258例（93.5%）通过蓝色染料和γ探针联合识别。肥胖、肿瘤位于外上象限以外以及术前淋巴闪烁显像未显示SLN与定位失败显著相关（分别为p<0.001、p=0.00
