Department of Breast Surgery, National Hospital Organization Kure Medical Center and Chugoku Cancer Center, 3-1, Aoyama-cho, Kure, Hiroshima, 737-0023, Japan.
Department of Pathology, National Hospital Organization Kure Medical Center and Chugoku Cancer Center, Kure, Hiroshima, Japan.
Breast Cancer. 2018 Mar;25(2):191-197. doi: 10.1007/s12282-017-0811-y. Epub 2017 Nov 1.
Intraoperative evaluations of sentinel lymph node (SLN) metastases are performed for providing appropriate and immediate axillary treatments in breast cancer patients who do not meet Z0011 criteria; however, standard intraoperative procedure has not yet been established.
We consecutively performed intraoperative evaluation for SLN metastases using both a cytokeratin immunohistochemistry (CK-IHC) assay on serial frozen sections and a one-step nucleic acid amplification (OSNA) assay of the remaining whole node in patients with invasive breast cancer. In this article, we compared the intraoperative diagnostic ability of CK-IHC assay, the OSNA assay, and in combination.
Between August 2009 and May 2017, 1,103 SLNs from 499 consecutive clinically node-negative invasive breast cancers were intraoperatively evaluated for SLN metastases using an OSNA and CK-IHC assay. The detection rates of SLN metastases by the OSNA and CK-IHC assays and in combination were 11.8, 12.1, and 14.5%, respectively. The concordance rate between the intraoperative SLN findings of the OSNA and CK-IHC assays was 94.9% (95% confidence interval 93.6-96.2%). The false negative rate for the OSNA assay was 3.1% (30/973), including 3 (0.3%) macrometastases and 27 (2.8%) micrometastases, and for the CK-IHC assay was 2.7% (26/969), including 1 (0.1%) OSNA ++ and 25 (2.6%) OSNA +.
The CK-IHC assay and the OSNA assay have compatible diagnostic abilities in intraoperative evaluations for SLN metastases. The low incidence of false negative results with limited disease burden suggests that both assays can be reliable techniques for intraoperative diagnoses of SLN metastases in breast cancer patients.
对于不符合 Z0011 标准的乳腺癌患者，术中评估前哨淋巴结 (SLN) 转移情况可提供适当且即时的腋窝治疗；然而，标准的术中程序尚未建立。
我们连续对浸润性乳腺癌患者的 SLN 转移进行了两种术中评估，即使用连续冷冻切片的细胞角蛋白免疫组织化学 (CK-IHC) 检测和剩余整个淋巴结的一步核酸扩增 (OSNA) 检测。在本文中，我们比较了 CK-IHC 检测、OSNA 检测及其组合的术中诊断能力。
2009 年 8 月至 2017 年 5 月，499 例临床淋巴结阴性浸润性乳腺癌患者的 1103 枚 SLN 术中采用 OSNA 和 CK-IHC 检测评估 SLN 转移情况。OSNA 和 CK-IHC 检测及联合检测的 SLN 转移检出率分别为 11.8%、12.1%和 14.5%。OSNA 和 CK-IHC 检测的术中 SLN 结果的一致性为 94.9%（95%置信区间 93.6-96.2%）。OSNA 检测的假阴性率为 3.1%（30/973），包括 3 枚（0.3%）大转移和 27 枚（2.8%）微转移；CK-IHC 检测的假阴性率为 2.7%（26/969），包括 1 枚（0.1%）OSNA++和 25 枚（2.6%）OSNA+。
在 SLN 转移的术中评估中，CK-IHC 检测和 OSNA 检测具有相当的诊断能力。两种检测方法的假阴性率均较低，且疾病负担有限，这表明这两种检测方法均是乳腺癌患者 SLN 转移术中诊断的可靠技术。
