One-Step Nucleic Acid Amplification (OSNA) of Sentinel Lymph Node in Early-Stage Endometrial Cancer: Spanish Multicenter Study (ENDO-OSNA)

Simple Summary One-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 in...

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Autores: Diestro, MD, Berjon, A, Zapardiel, I, Yebenes, L, Ruiz, I, Lekuona, A, Rezola, M, Jaunarena, I, Siegrist, J, Sanchez-Pastor, M, Cuadra, M, Sagasta, A, Guerra, I, Lete, LI, Roldan, F, Marta, CB, Boillos, M, Cardiel, M, Lopez-de la Manzanara, C, Relea, F, Coronado, P, Pascual, A, Roman, M, Peiro, G, Matute, L, Montero, B, Muruzabal, J, Guarch, R, Zorrero, C, Calatrava, A, Ribot, L, Costa, I, Hernandez, A, Hardisson, D
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2021
País:España
Institución:Instituto de Investigación Biomédica y Sanitaria de Alicante (ISABIAL)
Repositorio:r-ISABIAL. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica y Sanitaria de Alicante
OAI Identifier:oai:isabial.fundanetsuite.com:p7526
Acceso en línea:https://isabial.portalinvestigacion.com/publicaciones7526
Access Level:acceso abierto
Palabra clave:endometrial cancer
sentinel lymph node
micrometastases
ultrastaging
one-step nucleic acid amplification
OSNA
cytokeratin 19
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spelling One-Step Nucleic Acid Amplification (OSNA) of Sentinel Lymph Node in Early-Stage Endometrial Cancer: Spanish Multicenter Study (ENDO-OSNA)Diestro, MDBerjon, AZapardiel, IYebenes, LRuiz, ILekuona, ARezola, MJaunarena, ISiegrist, JSanchez-Pastor, MCuadra, MSagasta, AGuerra, ILete, LIRoldan, FMarta, CBBoillos, MCardiel, MLopez-de la Manzanara, CRelea, FCoronado, PPascual, ARoman, MPeiro, GMatute, LMontero, BMuruzabal, JGuarch, RZorrero, CCalatrava, ARibot, LCosta, IHernandez, AHardisson, Dendometrial cancersentinel lymph nodemicrometastasesultrastagingone-step nucleic acid amplificationOSNAcytokeratin 19Simple Summary One-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 mu m 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/mu L), 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.MDPI2021info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttps://isabial.portalinvestigacion.com/publicaciones7526CancersISSN: 20726694reponame:r-ISABIAL. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica y Sanitaria de Alicanteinstname:Instituto de Investigación Biomédica y Sanitaria de Alicante (ISABIAL)Inglésinfo:eu-repo/semantics/openAccessoai:isabial.fundanetsuite.com:p75262026-06-12T10:20:37Z
dc.title.none.fl_str_mv One-Step Nucleic Acid Amplification (OSNA) of Sentinel Lymph Node in Early-Stage Endometrial Cancer: Spanish Multicenter Study (ENDO-OSNA)
title One-Step Nucleic Acid Amplification (OSNA) of Sentinel Lymph Node in Early-Stage Endometrial Cancer: Spanish Multicenter Study (ENDO-OSNA)
spellingShingle One-Step Nucleic Acid Amplification (OSNA) of Sentinel Lymph Node in Early-Stage Endometrial Cancer: Spanish Multicenter Study (ENDO-OSNA)
Diestro, MD
endometrial cancer
sentinel lymph node
micrometastases
ultrastaging
one-step nucleic acid amplification
OSNA
cytokeratin 19
title_short One-Step Nucleic Acid Amplification (OSNA) of Sentinel Lymph Node in Early-Stage Endometrial Cancer: Spanish Multicenter Study (ENDO-OSNA)
title_full One-Step Nucleic Acid Amplification (OSNA) of Sentinel Lymph Node in Early-Stage Endometrial Cancer: Spanish Multicenter Study (ENDO-OSNA)
title_fullStr One-Step Nucleic Acid Amplification (OSNA) of Sentinel Lymph Node in Early-Stage Endometrial Cancer: Spanish Multicenter Study (ENDO-OSNA)
title_full_unstemmed One-Step Nucleic Acid Amplification (OSNA) of Sentinel Lymph Node in Early-Stage Endometrial Cancer: Spanish Multicenter Study (ENDO-OSNA)
title_sort One-Step Nucleic Acid Amplification (OSNA) of Sentinel Lymph Node in Early-Stage Endometrial Cancer: Spanish Multicenter Study (ENDO-OSNA)
dc.creator.none.fl_str_mv Diestro, MD
Berjon, A
Zapardiel, I
Yebenes, L
Ruiz, I
Lekuona, A
Rezola, M
Jaunarena, I
Siegrist, J
Sanchez-Pastor, M
Cuadra, M
Sagasta, A
Guerra, I
Lete, LI
Roldan, F
Marta, CB
Boillos, M
Cardiel, M
Lopez-de la Manzanara, C
Relea, F
Coronado, P
Pascual, A
Roman, M
Peiro, G
Matute, L
Montero, B
Muruzabal, J
Guarch, R
Zorrero, C
Calatrava, A
Ribot, L
Costa, I
Hernandez, A
Hardisson, D
author Diestro, MD
author_facet Diestro, MD
Berjon, A
Zapardiel, I
Yebenes, L
Ruiz, I
Lekuona, A
Rezola, M
Jaunarena, I
Siegrist, J
Sanchez-Pastor, M
Cuadra, M
Sagasta, A
Guerra, I
Lete, LI
Roldan, F
Marta, CB
Boillos, M
Cardiel, M
Lopez-de la Manzanara, C
Relea, F
Coronado, P
Pascual, A
Roman, M
Peiro, G
Matute, L
Montero, B
Muruzabal, J
Guarch, R
Zorrero, C
Calatrava, A
Ribot, L
Costa, I
Hernandez, A
Hardisson, D
author_role author
author2 Berjon, A
Zapardiel, I
Yebenes, L
Ruiz, I
Lekuona, A
Rezola, M
Jaunarena, I
Siegrist, J
Sanchez-Pastor, M
Cuadra, M
Sagasta, A
Guerra, I
Lete, LI
Roldan, F
Marta, CB
Boillos, M
Cardiel, M
Lopez-de la Manzanara, C
Relea, F
Coronado, P
Pascual, A
Roman, M
Peiro, G
Matute, L
Montero, B
Muruzabal, J
Guarch, R
Zorrero, C
Calatrava, A
Ribot, L
Costa, I
Hernandez, A
Hardisson, D
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv endometrial cancer
sentinel lymph node
micrometastases
ultrastaging
one-step nucleic acid amplification
OSNA
cytokeratin 19
topic endometrial cancer
sentinel lymph node
micrometastases
ultrastaging
one-step nucleic acid amplification
OSNA
cytokeratin 19
description Simple Summary One-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 mu m 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/mu L), 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.
publishDate 2021
dc.date.none.fl_str_mv 2021
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://isabial.portalinvestigacion.com/publicaciones7526
url https://isabial.portalinvestigacion.com/publicaciones7526
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv MDPI
publisher.none.fl_str_mv MDPI
dc.source.none.fl_str_mv Cancers
ISSN: 20726694
reponame:r-ISABIAL. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica y Sanitaria de Alicante
instname:Instituto de Investigación Biomédica y Sanitaria de Alicante (ISABIAL)
instname_str Instituto de Investigación Biomédica y Sanitaria de Alicante (ISABIAL)
reponame_str r-ISABIAL. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica y Sanitaria de Alicante
collection r-ISABIAL. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica y Sanitaria de Alicante
repository.name.fl_str_mv
repository.mail.fl_str_mv
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score 15.811543

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