Kostun Jan, Nowosielski Krzysztof, Jedryka Marcin A, Hardisson David, Restaino Stefano, Gatius Sonia, Novak Zoltan, Lacalle Amaia Sagasta, Lopez Susana, Pešta Martin, Zebalski Marcin, Lepka Piotr, Diestro María Dolores, Vizzielli Giuseppe, Matias-Guiu Xavier, Echim Tímea, Urkaray Emma Natalia Camacho, Rienda Iván, Slunečko Robert, Czekanski Andrzej, Berjón Alberto, Mariuzzi Laura, Velasco Ana, Betenbuk Judit, Merino Isabel Guerra, Padilla-Iserte Pablo, Stráník Petr, Smoligová Vendula, Presl Jiří
Department of Gynecology and Obstetrics, University Hospital in Pilsen, Charles University, Pilsen, Czech Republic.
Department of Gynecology and Gynecological Oncology, University Clinical Center of Medical University of Silesia, Katowice, Poland.
Cancer Med. 2025 Sep;14(18):e71268. doi: 10.1002/cam4.71268.
This European multicenter study aimed to assess the diagnostic accuracy of one-step nucleic acid amplification (OSNA) as the primary endpoint by comparing this method with ultrastaging for the detection of sentinel node metastases in endometrial cancer patients.
European multicenter prospective performance study including data from 10 centers across 5 European countries. Each node, upon removal of surrounding adipose tissue, was sliced in 2 mm thick sections and equally distributed between ultrastaging and OSNA. OSNA is based on cytokeratin-19 detection, serving as a metastatic marker. Sensitivity, specificity, and concordance of OSNA versus ultrastaging were calculated at nodal and patient levels.
Seven hundred forty-three sentinel nodes from 366 patients were evaluated. Compared to ultrastaging, OSNA showed concordance, specificity, and sensitivity of 95%, 97.6%, and 41.2% at the nodal level and 93.2%, 96.2%, and 47.8% at the patient level, respectively. In reverse analysis, when compared to OSNA, the ultrastaging showed a sensitivity of 45.2% and 45.8% at the nodal and patient levels, respectively. Irrespective of the size of metastasis, both methods agreed in 14 positive and 692 negative nodes (95%). This resulted in 24 (6.56%) patients with a positive OSNA and 23 (6.28%) patients with a positive ultrastaging finding. The number of discordant nodes was 47 (6.33%), 40 (85.1%) of them were micrometastases. Benign epithelial inclusions occurred in 4 nodes (0.54%) and 4 patients (1.09%).
Compared with ultrastaging, OSNA showed high concordance and specificity, but sensitivity was low-similar to ultrastaging compared with OSNA as an index test in reverse analysis. The main limitation in comparing the two approaches by splitting the sentinel nodes was the tissue allocation bias. As reflected in the number of discordant cases, especially at the micrometastases level. The distribution of patients with node metastases was comparable between the two methods at both the nodal and patient levels.
German Clinical Trial Register: Nr. DRKS00021520.
这项欧洲多中心研究旨在通过将一步核酸扩增（OSNA）与超分期法相比较，以检测子宫内膜癌患者前哨淋巴结转移情况，评估OSNA作为主要终点的诊断准确性。
欧洲多中心前瞻性效能研究，纳入来自5个欧洲国家10个中心的数据。每个淋巴结在去除周围脂肪组织后，切成2毫米厚的切片，并平均分配用于超分期和OSNA检测。OSNA基于细胞角蛋白-19检测，作为转移标志物。在淋巴结和患者层面计算OSNA与超分期法的敏感性、特异性和一致性。
对366例患者的743个前哨淋巴结进行了评估。与超分期法相比，OSNA在淋巴结层面的一致性、特异性和敏感性分别为95%、97.6%和41.2%，在患者层面分别为93.2%、96.2%和47.8%。在反向分析中，与OSNA相比，超分期法在淋巴结和患者层面的敏感性分别为45.2%和45.8%。无论转移灶大小如何，两种方法在14个阳性和692个阴性淋巴结上结果一致（95%）。这导致24例（6.56%）患者OSNA结果为阳性，23例（6.28%）患者超分期结果为阳性。不一致的淋巴结有47个（6.33%），其中40个（85.1%）为微转移灶。4个淋巴结（0.54%）和4例患者（1.09%）出现良性上皮包涵体。
与超分期法相比，OSNA显示出较高的一致性和特异性，但敏感性较低——在反向分析中，与将OSNA作为指标检测的超分期法相似。通过分割前哨淋巴结比较这两种方法的主要局限性是组织分配偏差。如在不一致病例数量中所反映的，尤其是在微转移灶层面。两种方法在淋巴结和患者层面有淋巴结转移的患者分布相当。
德国临床试验注册中心：编号DRKS00021520。
