One-step nucleic acid amplification (OSNA) of Sentinel Lymph Node in Early Stage Endometrial Cancer: Spanish Multicenter Study (ENDO-OSNA)

Autor: Irmgard Costa, Alberto Berjón, Maria Dolores Diestro, Marta Rezola, M. Sánchez-Pastor, Juan Carlos Muruzabal, Beatriz Montero, Isabel Guerra, Alicia Hernández, Cristina Zorrero, Rosa Guarch, Pluvio J. Coronado, L. I. Lete, F. Relea, C.-B. Marta, Maria Jose Román, Jaime Siegrist, Alejandro Pascual, Fernando Roldan, David Hardisson, M. J. Boillos, L. Ribot, Amaia Sagasta, Gloria Peiró, Arantza Lekuona, Luis Matute, L. Yébenes, Irune Ruiz, María Cuadra, Ignacio Zapardiel, M. J. Cardiel, Ibon Jaunarena, A. Calatrava, C. López-de la Manzanara
Rok vydání: 2021
Předmět:
DOI: 10.20944/preprints202107.0369.v1
Popis: 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. 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 analysed 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.
Databáze: OpenAIRE