Jan Kostun

One‐Step Nucleic Acid Amplification Analysis of Sentinel Lymphatic Nodes in Endometrial Cancer Patients ( EU ‐ OSNA ): A European Multicenter Diagnostic Accuracy Study

ABSTRACT Objective 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. Methods 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. Results 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%). Conclusion 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. Trial Registration German Clinical Trial Register: Nr. DRKS00021520

One‐Step Nucleic Acid Amplification Analysis of Sentinel Nodes in Endometrial Cancer Versus Ultrastaging: First Long‐Term Follow‐Up Data of Discordant Cases

ABSTRACTAimsEndometrial cancer (EC) is the most common gynecological cancer worldwide and its incidence is rising. The cornerstone of its management is surgical treatment with nodal staging. A monocentric study investigating the potential of the molecular biology method of one‐step nucleic acid amplification (OSNA) in sentinel lymph node (SLN) analysis was conducted at our institution between April 2016 and January 2018. Histopathological ultrastaging was used as the reference standard for SLN examination and OSNA as the index test. The aim of this study was to assess the long‐term outcome of patients with discordant SLN and OSNA results. To our knowledge, this is the first study exploring this issue.Methods and ResultsPatients were followed in line with the current ESMO/ESGO/ESTRO recommendations. The institutional electronic database was retrospectively searched for patients' follow‐up data from April 2016 till March 2023. Only patients who provided a written valid consent and had a positive OSNA and negative ultrastaging of their SLN analysis were included in the study. The primary endpoint was the retrospective analysis of their clinical outcome. Data from 58 patients enrolled into our previous study were reviewed and 12 discordant patients who met the inclusion criteria for this study were identified. The median follow‐up was 83 months. Disease recurrence was detected in 3 (25%) patients, two of these were nodal and both patients died. One patient had a solitary lung metastasis which was surgically treated, and the patient was disease‐free during the whole study period.ConclusionThe recurrence rate of patients included in the study was in the intermediate‐high and high‐risk group range, and hence, higher than expected based on ultrastaging results. Furthermore, benign epithelial inclusions do not seem to adversely affect OSNA SLN analysis in EC patients.

The influence of selected immunohistochemical and clinical-pathological markers on the prognosis of patients with malignant uterine tumors

Introduction: Endometrial carcinoma is the most common gynecological malignancy in developed countries, and its incidence has been increasing in recent decades. The prognosis of patients depends on a combination of clinical-pathological characteristics, and more recently, molecular indicators. The aim of this study was to analyze the influence of the selected prognostic markers – immunohistochemical (L1CAM, ER, PR) and classical (FIGO stage, grade, myometrial invasion, lymph node involvement, distant metastases) – on the survival of patients with endometrial carcinoma. Materials and methods: A retrospective evaluation was performed on 143 women with histologically confirmed endometrial cancer treated between 2014 and 2018. All patients underwent primary surgical treatment. Resected specimens were subjected to immunohistochemical analysis of L1CAM, ER, and PR. Data were statistically processed using a Kaplan-Meier analysis and the Cox proportional hazards model, adjusted to age. Results: L1CAM expression was detected in 14% of patients and was associated with shortened survival (HR ≈ 3.9). ER and PR positivity (89% and 85%, resp.) correlated with a more favorable prognosis (HR for ER positivity 0.21; PR 0.23). Classical factors such as higher grade, advanced FIGO stage, cervical and lymphovascular invasion, or presence in nodes were statistically associated with worse survival. An interesting finding was a significantly better prognosis in asymptomatic patients – the presence of symptoms increased the risk of death up to fourfold. Conclusion: L1CAM positivity and loss of hormone receptors are significant adverse prognostic factors. Their inclusion in routine immunohistochemical panel testing improves risk stratification and treatment personalization, which at the time of publication of this paper is already included in the updated ESGO-ESTRO-ESP 2025 guidelines. At the same time, it has been shown that the absence of symptoms at diagnosis is a favorable survival indicator. The results support further research into prognostic markers and their integration into clinical decision-making algorithms. Key words: endometrial carcinoma – L1 cell adhesion molecule – estrogen receptors – progesterone receptors – survival – symptoms