Abstract
Simple SummaryOne-step nucleic acid amplification (OSNA) is an automated molecular diagnostic assay used to detect metastases by analyzing the levels of cytokeratin 19 mRNA in whole lymph nodes. It has been validated as an accurate and reliable tool for staging in several types of cancers and is included in the National Institute for Health and Care Excellence guidelines for the management of breast cancer. ENDO-OSNA is a large, observational, multicenter study designed to evaluate the efficacy of OSNA for the detection of sentinel lymph node (SLN) metastasis in patients with early-stage endometrial cancer. We found that the OSNA assay shows higher sensitivity, specificity, and diagnostic accuracy in the detection of SLN metastasis, including low-volume metastasis, compared to standard pathological ultrastaging. Moreover, OSNA could aid in the identification of patients with intermediate or high-risk endometrial cancer, and lead to treatment decisions that could improve their prognosis.The objective of this study was to evaluate the efficacy of one-step nucleic acid amplification (OSNA) for the detection of sentinel lymph node (SLN) metastasis compared to standard pathological ultrastaging in patients with early-stage endometrial cancer (EC). A total of 526 SLNs from 191 patients with EC were included in the study, and 379 SLNs (147 patients) were evaluated by both methods, OSNA and standard pathological ultrastaging. The central 1 mm portion of each lymph node was subjected to semi-serial sectioning at 200 μm intervals and examined by hematoxylin–eosin and immunohistochemistry with CK19; the remaining tissue was analyzed by OSNA for CK19 mRNA. The OSNA assay detected metastases in 19.7% of patients (14.9% micrometastasis and 4.8% macrometastasis), whereas pathological ultrastaging detected metastasis in 8.8% of patients (3.4% micrometastasis and 5.4% macrometastasis). Using the established cut-off value for detecting SLN metastasis by OSNA in EC (250 copies/μL), the sensitivity of the OSNA assay was 92%, specificity was 82%, diagnostic accuracy was 83%, and the negative predictive value was 99%. Discordant results between both methods were recorded in 20 patients (13.6%). OSNA resulted in an upstaging in 12 patients (8.2%). OSNA could aid in the identification of patients requiring adjuvant treatment at the time of diagnosis.
Highlights
Endometrial cancer (EC) is the most frequently diagnosed gynecologic malignancy in Europe, with an estimated incidence of 130,051 new cases and 29,963 deaths in 2020 [1,2]
The sensitivity of the one-step nucleic acid amplification (OSNA) assay was 92%, specificity was 82%, and diagnostic accuracy was 83%
Prospective, observational, multicenter study (ENDO-OSNA), we analyzed the usefulness of the OSNA assay compared to conventional pathological ultrastaging in detecting sentinel lymph node (SLN) metastasis in a series of 191 patients with early-stage endometrial cancer (EC)
Summary
Endometrial cancer (EC) is the most frequently diagnosed gynecologic malignancy in Europe, with an estimated incidence of 130,051 new cases and 29,963 deaths in 2020 [1,2]. Most cases are low-grade, early-stage tumors, and are classified into low- or intermediaterisk categories, according to standard clinico-pathological features [3]. Surgery is the primary treatment, followed by adjuvant radiotherapy and/or chemotherapy depending on risk group stratification, and staging is based on pathological evaluation after surgery. Around 10% of early-stage EC patients have lymph node metastases at the time of diagnosis and their presence negatively influences survival [5]. The prognostic value of systematic lymphadenectomy for patients with early-stage EC is controversial, with several studies reporting conflicting results [6,7,8,9,10,11]. Treatment of pelvic lymph nodes may not confer a direct therapeutic benefit and could increase the risk of complications such as lymphedema [9]
Sign-in/Register to view highlights & summary Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
