Department of Gynecology and Obstetrics, Universitätsklinikum Schleswig-Holstein, Arnold-Heller-Strasse 3, Haus 24, Campus Kiel, 24105, Kiel, Germany,
J Cancer Res Clin Oncol. 2013 Oct;139(10):1649-55. doi: 10.1007/s00432-013-1481-6. Epub 2013 Aug 2.
The purpose of this single-center study was to determine the practicability of the intra-operative use of one-step nucleic acid amplification (OSNA) as the only method for detection of SLN. The OSNA system has been well described and is supposed to be as accurate as conventional histology.
Three hundred and thirty SLNs from 143 breast cancer patients were analyzed in an intra-operative setting. The CK19-copy number was determined by OSNA and divided into 3 results ("-" no metastasis; "+" micrometastasis; "++" marcometastasis). If OSNA gave a positive result, an axillary lymph node dissection was carried out during the same session. The central 1-mm slice of each node was obtained for permanent histology. Additionally, the results were correlated to clinicopathological factors, and the time for the intra-operative use was evaluated.
Thirty-nine of the 143 patients were OSNA positive, 22 with macrometastatic and 17 with micrometastatic spread. The mean time for the OSNA run with one SLN was 34.4 min. We could show a correlation between the tumor size and OSNA positivity as well as between the numbers of OSNA positive SLNs with the tumor load of associated non-SLNs. Furthermore, we found that a cutoff CK19 copy number of 7,900/μL indicates a positive non-SLN result with the highest sensitivity (91 %) and specificity (61 %).
We found OSNA to be very helpful for the intra-operative determination of the tumor load of a SLN as a basis for decision-making concerning further surgical axillary intervention. OSNA allows precise differentiation of micro- from macrometastasis, and the CK19 copy number predicts the probability of tumor load in other axillary lymph nodes and might help to find adequate adjuvant treatment options. This objective method is well suitable for everyday use and may reduce the pathologic workload and the risk of secondary operative interventions with all associated costs and stress for the patients.
本单中心研究旨在确定一步法核酸扩增（OSNA）作为唯一的 SLN 检测方法的实用性。OSNA 系统已得到充分描述，据推测其准确性与常规组织学相当。
在术中环境下分析了 143 例乳腺癌患者的 330 个 SLN。通过 OSNA 测定 CK19 拷贝数，并将其分为 3 种结果（“-”无转移；“+”微转移；“++”宏转移）。如果 OSNA 结果为阳性，则在同一手术中进行腋窝淋巴结清扫。每个淋巴结的中心 1mm 切片用于永久组织学检查。此外，将结果与临床病理因素相关联，并评估术中使用的时间。
143 例患者中有 39 例 OSNA 阳性，其中 22 例有宏转移，17 例有微转移。用一个 SLN 进行 OSNA 运行的平均时间为 34.4 分钟。我们可以证明肿瘤大小与 OSNA 阳性之间以及 OSNA 阳性 SLN 数量与相关非 SLN 肿瘤负荷之间存在相关性。此外，我们发现 CK19 拷贝数为 7900/μL 的截点可指示非 SLN 结果为阳性，其具有最高的灵敏度（91%）和特异性（61%）。
我们发现 OSNA 非常有助于术中确定 SLN 的肿瘤负荷，从而为进一步的腋窝手术干预决策提供依据。OSNA 可准确区分微转移和宏转移，CK19 拷贝数可预测其他腋窝淋巴结的肿瘤负荷概率，并可能有助于找到合适的辅助治疗方案。这种客观方法非常适合日常使用，可以减少病理工作量和二次手术干预的风险，同时减轻患者的相关成本和压力。
