Department of Breast Surgical Oncology, Hakuaikai Medical Corporation, Sagara Hospital, 3-31 Matsubara-cho, Kagoshima, Kagoshima, 892-0833, Japan.
Breast Cancer. 2013 Apr;20(2):181-6. doi: 10.1007/s12282-011-0324-z. Epub 2011 Dec 28.
The one-step nucleic acid amplification (OSNA) method can assess the expression level of cytokeratin 19 mRNA in sentinel lymph nodes in breast cancer. We compared the time required for diagnosis and concordance of results between the OSNA method and conventional intraoperative pathological examination. We then examined the relationship between the frequency of non-sentinel lymph node metastasis and (1) the expression level of CK19 mRNA in the sentinel lymph nodes and (2) clinico-pathological features of the primary tumor.
In the comparison study, pairs of sentinel lymph node sections from 53 consecutive patients were examined: one section by hematoxylin-eosin staining and the other by OSNA assay. The latter involved reverse-transcription loop-mediated isothermal amplification of cytokeratin 19 mRNA, assessed quantitatively. In the second phase, 306 sentinel lymph nodes were removed from 248 consecutive patients, and whole sentinel lymph nodes were examined by OSNA assay alone.
OSNA assay was a little more time-consuming than conventional pathological diagnosis (34-45 vs. 22-25 min, p < 0.0001). Concordance between the two methods was 93%. The frequency of non-sentinel lymph node metastasis (p < 0.0001) and the total number of lymph node metastases (p < 0.0001) increased with the amount of cytokeratin 19 mRNA on OSNA assay. We found no significant relationship between the amount of cytokeratin 19 mRNA in sentinel lymph nodes and breast cancer immunohistochemical subtype.
The OSNA method is suitable to detect sentinel lymph node metastasis and to predict the possibility of non-sentinel metastasis. This semi-automated quantitative analysis system reduces the burden on pathologists.
一步法核酸扩增（OSNA）方法可评估乳腺癌前哨淋巴结中细胞角蛋白 19 mRNA 的表达水平。我们比较了 OSNA 方法和常规术中病理检查在诊断所需时间和结果一致性方面的差异。然后，我们研究了非前哨淋巴结转移的频率与（1）前哨淋巴结中 CK19 mRNA 的表达水平和（2）原发肿瘤的临床病理特征之间的关系。
在比较研究中，对 53 例连续患者的前哨淋巴结切片进行了检查：一组通过苏木精-伊红染色检查，另一组通过 OSNA 检测。后者涉及细胞角蛋白 19 mRNA 的逆转录环介导等温扩增，进行定量评估。在第二阶段，对 248 例连续患者的 306 个前哨淋巴结进行了切除，整个前哨淋巴结仅通过 OSNA 检测进行检查。
OSNA 检测比常规病理诊断稍耗时（34-45 分钟与 22-25 分钟，p<0.0001）。两种方法的一致性为 93%。非前哨淋巴结转移的频率（p<0.0001）和淋巴结转移总数（p<0.0001）随着 OSNA 检测中细胞角蛋白 19 mRNA 的量的增加而增加。我们没有发现前哨淋巴结中细胞角蛋白 19 mRNA 的量与乳腺癌免疫组织化学亚型之间存在显著关系。
OSNA 方法适用于检测前哨淋巴结转移，并预测非前哨转移的可能性。这种半自动定量分析系统减轻了病理学家的负担。
