Factors affecting failed localisation and false-negative rates of sentinel node biopsy in breast cancer - results of the ALMANAC validation phase
Factors affecting failed localisation and false-negative rates of sentinel node biopsy in breast cancer - results of the ALMANAC validation phase
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DOI：
10.1007/s10549-006-9192-1
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发表时间：
2006-09-01
影响因子：
3.8
通讯作者：
Mansel, Robert E.
中科院分区：
文献类型：
--
作者：
Goyal, Amit;Newcombe, Robert G.;Mansel, Robert E.
背景。尽管前哨淋巴结活检（SLNB）广泛应用于早期乳腺癌，但在报道的测试性能特征方面存在很大差异。本前瞻性多中心验证研究的主要目的是量化SLNB的检出率和假阴性率，并评估影响其的因素。842名临床淋巴结阴性乳腺癌患者根据使用放射性药物99mtc -白蛋白胶体和专利蓝V染料组合的标准化方案接受了SLNB。所有患者均在同一手术中进行标准腋窝治疗。836例可评估病例中有803例（96.1%）发现前哨淋巴结（sln）。每位患者切除的sln中位数为2个（范围1-9个）。假阴性19例，灵敏度263/282(93.3%)，准确率782/803（97.6%）。698例（85.6%）患者通过蓝色染料鉴定出sln， 698例（85.6%）患者通过同位素鉴定出sln， 815例患者中蓝色染料和同位素联合鉴定出782例（96.0%）。276例淋巴结阳性患者中，251例（90.9%）通过蓝色染料检测到一个或多个阳性sln， 246例（89.1%）通过同位素检测到，258例（93.5%）通过蓝色染料和伽马探针联合检测到。肥胖、肿瘤位于上外象限以外以及术前淋巴扫描未发现sln与定位失败显著相关（p < 0.001, p=0.008, p < 0.001）。3级肿瘤患者的假阴性率为9.6%，2级肿瘤患者的假阴性率为4.7% （p=0.022）。切除一个SLN患者的假阴性率为10.1%，而切除多个SLN（3个或更多）患者的假阴性率为1.1% （p=0.010）。SLNB可以准确判断临床腋窝淋巴结阴性的早期乳腺癌患者是否存在腋窝转移。蓝色染料和同位素的结合使用提高了SLNB的成功率和准确性。SLNB成功率随着体重的增加、肿瘤位于上外象限以外以及术前淋巴扫描未发现热淋巴结而降低。该研究表明，SLNB阴性在3级肿瘤中的预测价值降低。
Background. 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.Methods. 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.Results. 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).Conclusion. 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.