Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

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

Version 1 : Received: 15 July 2021 / Approved: 16 July 2021 / Online: 16 July 2021 (11:57:14 CEST)

A peer-reviewed article of this Preprint also exists.

Diestro, M.D.; Berjón, A.; Zapardiel, I.; Yébenes, L.; Ruiz, I.; Lekuona, A.; Rezola, M.; Jaunarena, I.; Siegrist, J.; Sánchez-Pastor, M.; Cuadra, M.; Sagasta, A.; Guerra, I.; Lete, L.I.; Roldán, F.; Marta, C.B.; Boillos, M.J.; Cardiel, M.J.; Carlos, L.-D.M.; Relea, F.; Coronado, P.J.; Pascual, A.; Román, M.J.; Peiró, G.; Matute, L.J.; Montero, B.; Muruzábal, J.C.; Guarch, R.; Zorrero, C.; Calatrava, A.; Ribot, L.; Costa, I.; Hernández, A.; Hardisson, D. One-Step Nucleic Acid Amplification (OSNA) of Sentinel Lymph Node in Early-Stage Endometrial Cancer: Spanish Multicenter Study (ENDO-OSNA). Cancers 2021, 13, 4465. Diestro, M.D.; Berjón, A.; Zapardiel, I.; Yébenes, L.; Ruiz, I.; Lekuona, A.; Rezola, M.; Jaunarena, I.; Siegrist, J.; Sánchez-Pastor, M.; Cuadra, M.; Sagasta, A.; Guerra, I.; Lete, L.I.; Roldán, F.; Marta, C.B.; Boillos, M.J.; Cardiel, M.J.; Carlos, L.-D.M.; Relea, F.; Coronado, P.J.; Pascual, A.; Román, M.J.; Peiró, G.; Matute, L.J.; Montero, B.; Muruzábal, J.C.; Guarch, R.; Zorrero, C.; Calatrava, A.; Ribot, L.; Costa, I.; Hernández, A.; Hardisson, D. One-Step Nucleic Acid Amplification (OSNA) of Sentinel Lymph Node in Early-Stage Endometrial Cancer: Spanish Multicenter Study (ENDO-OSNA). Cancers 2021, 13, 4465.

Journal reference: Cancers 2021, 13, 4465
DOI: 10.3390/cancers13174465

Abstract

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.

Keywords

Endometrial cancer; sentinel lymph node; micrometastases; ultrastaging; one-step nucleic acid amplification; OSNA; cytokeratin 19

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