Engels Svenja, Brautmeier Lutz, Reinhardt Lena, Wasylow Clara, Hasselmann Friederike, Henke Rolf P, Wawroschek Friedhelm, Winter Alexander
University Hospital for Urology, Klinikum Oldenburg, Department of Human Medicine, School of Medicine and Health Sciences, Carl von Ossietzky University Oldenburg, 26129 Oldenburg, Germany.
Oldenburg Institute of Pathology, 26122 Oldenburg, Germany.
Cancers (Basel). 2021 Mar 5;13(5):1117. doi: 10.3390/cancers13051117.
: In clinical routine, only fractions of lymph nodes (LNs) are examined histopathologically, often resulting in missed (micro-)metastases and incorrect staging of prostate cancer (PCa). One-step nucleic acid amplification (OSNA) analyzes the entire LN by detecting cytokeratin 19 (CK19) mRNA as a surrogate for LN metastases requiring less effort than conventional biomolecular techniques. We aimed to evaluate performance of OSNA in detecting sentinel LN (SLN) metastases in PCa. : SLNs ( = 534) of 64 intermediate- or high-risk PCa patients undergoing radical prostatectomy with extended and sentinel-guided lymphadenectomy were cut into slices and alternatingly assigned to OSNA and histopathology (hematoxylin-eosin staining, CK19, and CK AE1/AE3 immunohistochemistry). Sensitivity and specificity of OSNA and concordance and measure of agreement (Cohen's kappa (κ)) between OSNA and histopathology were assessed. Histopathology revealed metastases in 76 SLNs. Sensitivity and specificity of OSNA were 84.2% and 96.1%, respectively. Discordant results were recorded for 30 of 534 SLNs, revealing high concordance (94.4%). Twenty-four discordant cases were classified as micrometastases, indicating a possible allocation bias. In 18 cases, positive results were conferred only by OSNA resulting in seven LN-positive patients who were missed by histopathology. Overall, the level of agreement was high (κ = 0.78). OSNA provided a diagnosis that was as least as accurate as detailed histological examination and might improve LN staging in PCa.
在临床常规操作中，仅对部分淋巴结进行组织病理学检查，这常常导致前列腺癌（PCa）的（微）转移灶被漏检以及分期错误。一步核酸扩增（OSNA）通过检测细胞角蛋白19（CK19）mRNA来分析整个淋巴结，以此作为淋巴结转移的替代指标，相较于传统生物分子技术，所需工作量更少。我们旨在评估OSNA在检测PCa前哨淋巴结（SLN）转移方面的性能。对64例接受根治性前列腺切除术并进行扩大及前哨淋巴结引导下淋巴结清扫术的中高危PCa患者的534个SLN进行切片，并交替分配给OSNA和组织病理学检查（苏木精-伊红染色、CK19以及CK AE1/AE3免疫组织化学）。评估了OSNA的敏感性和特异性，以及OSNA与组织病理学之间的一致性和一致性度量（科恩kappa（κ）系数）。组织病理学检查发现76个SLN有转移。OSNA的敏感性和特异性分别为84.2%和96.1%。在534个SLN中，有30个出现了不一致的结果，显示出高度一致性（94.4%）。24例不一致的病例被归类为微转移，表明可能存在分配偏倚。在18例病例中，仅OSNA检测结果为阳性，导致7例淋巴结阳性患者被组织病理学检查漏检。总体而言，一致性水平较高（κ = 0.78）。OSNA提供的诊断至少与详细的组织学检查一样准确，并且可能改善PCa的淋巴结分期。
