A cut-off of 2150 cytokeratin 19 mRNA copy number in sentinel lymph node may be a powerful predictor of non-sentinel lymph node status in breast cancer patients.

Since 2007, one-step nucleic acid amplification (OSNA) has been used as a diagnostic system for sentinel lymph node (SLN) examination in patients with breast cancer. This study aimed to define a new clinical cut-off of CK19 mRNA copy number based on the calculation of the risk that an axillary lymph...

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Main Authors: Irene Terrenato, Valerio D'Alicandro, Beatrice Casini, Letizia Perracchio, Francesca Rollo, Laura De Salvo, Simona Di Filippo, Franco Di Filippo, Edoardo Pescarmona, Marcello Maugeri-Saccà, Marcella Mottolese, Simonetta Buglioni
Format: Article
Language:English
Published: Public Library of Science (PLoS) 2017-01-01
Series:PLoS ONE
Online Access:https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0171517&type=printable
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author Irene Terrenato
Valerio D'Alicandro
Beatrice Casini
Letizia Perracchio
Francesca Rollo
Laura De Salvo
Simona Di Filippo
Franco Di Filippo
Edoardo Pescarmona
Marcello Maugeri-Saccà
Marcella Mottolese
Simonetta Buglioni
Simonetta Buglioni
author_facet Irene Terrenato
Valerio D'Alicandro
Beatrice Casini
Letizia Perracchio
Francesca Rollo
Laura De Salvo
Simona Di Filippo
Franco Di Filippo
Edoardo Pescarmona
Marcello Maugeri-Saccà
Marcella Mottolese
Simonetta Buglioni
Simonetta Buglioni
author_sort Irene Terrenato
collection DOAJ
description Since 2007, one-step nucleic acid amplification (OSNA) has been used as a diagnostic system for sentinel lymph node (SLN) examination in patients with breast cancer. This study aimed to define a new clinical cut-off of CK19 mRNA copy number based on the calculation of the risk that an axillary lymph node dissection (ALND) will be positive. We analyzed 1529 SLNs from 1140 patients with the OSNA assay and 318 patients with positive SLNs for micrometastasis (250 copies) and macrometastasis (5000 copies) underwent ALND. Axillary non-SLNs were routinely examined. ROC curves and Youden's index were performed in order to identify a new cut-off value. Logistic regression models were performed in order to compare OSNA categorical variables created on the basis of our and traditional cut-off to better identify patients who really need an axillary dissection. 69% and 31% of OSNA positive patients had a negative and positive ALND, respectively. ROC analysis identified a cut-off of 2150 CK19 mRNA copies with 95% sensitivity and 51% specificity. Positive and negative predictive values of this new cut-off were 47% and 96%, respectively. Logistic regression models indicated that the cut-off of 2150 copies better discriminates patients with node negative or positive in comparison with the conventional OSNA cut-off (p<0.0001). This cut-off identifies false positive and false negative cases and true-positive and true negative cases very efficiently, and therefore better identifies which patients really need an ALND and which patients can avoid one. This is why we suggest that the negative cut-off should be raised from 250 to 2150. Furthermore, we propose that for patients with a copy number that ranges between 2150 and 5000, there should be a multidisciplinary discussion concerning the clinical and bio-morphological features of primary breast cancer before any decision is taken on whether to perform an ALND or not.
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spelling doaj-art-aee28c9ebf7c48ddbdc1ed6217c6c0592025-08-20T02:03:50ZengPublic Library of Science (PLoS)PLoS ONE1932-62032017-01-01122e017151710.1371/journal.pone.0171517A cut-off of 2150 cytokeratin 19 mRNA copy number in sentinel lymph node may be a powerful predictor of non-sentinel lymph node status in breast cancer patients.Irene TerrenatoValerio D'AlicandroBeatrice CasiniLetizia PerracchioFrancesca RolloLaura De SalvoSimona Di FilippoFranco Di FilippoEdoardo PescarmonaMarcello Maugeri-SaccàMarcella MottoleseSimonetta BuglioniSimonetta BuglioniSince 2007, one-step nucleic acid amplification (OSNA) has been used as a diagnostic system for sentinel lymph node (SLN) examination in patients with breast cancer. This study aimed to define a new clinical cut-off of CK19 mRNA copy number based on the calculation of the risk that an axillary lymph node dissection (ALND) will be positive. We analyzed 1529 SLNs from 1140 patients with the OSNA assay and 318 patients with positive SLNs for micrometastasis (250 copies) and macrometastasis (5000 copies) underwent ALND. Axillary non-SLNs were routinely examined. ROC curves and Youden's index were performed in order to identify a new cut-off value. Logistic regression models were performed in order to compare OSNA categorical variables created on the basis of our and traditional cut-off to better identify patients who really need an axillary dissection. 69% and 31% of OSNA positive patients had a negative and positive ALND, respectively. ROC analysis identified a cut-off of 2150 CK19 mRNA copies with 95% sensitivity and 51% specificity. Positive and negative predictive values of this new cut-off were 47% and 96%, respectively. Logistic regression models indicated that the cut-off of 2150 copies better discriminates patients with node negative or positive in comparison with the conventional OSNA cut-off (p<0.0001). This cut-off identifies false positive and false negative cases and true-positive and true negative cases very efficiently, and therefore better identifies which patients really need an ALND and which patients can avoid one. This is why we suggest that the negative cut-off should be raised from 250 to 2150. Furthermore, we propose that for patients with a copy number that ranges between 2150 and 5000, there should be a multidisciplinary discussion concerning the clinical and bio-morphological features of primary breast cancer before any decision is taken on whether to perform an ALND or not.https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0171517&type=printable
spellingShingle Irene Terrenato
Valerio D'Alicandro
Beatrice Casini
Letizia Perracchio
Francesca Rollo
Laura De Salvo
Simona Di Filippo
Franco Di Filippo
Edoardo Pescarmona
Marcello Maugeri-Saccà
Marcella Mottolese
Simonetta Buglioni
Simonetta Buglioni
A cut-off of 2150 cytokeratin 19 mRNA copy number in sentinel lymph node may be a powerful predictor of non-sentinel lymph node status in breast cancer patients.
PLoS ONE
title A cut-off of 2150 cytokeratin 19 mRNA copy number in sentinel lymph node may be a powerful predictor of non-sentinel lymph node status in breast cancer patients.
title_full A cut-off of 2150 cytokeratin 19 mRNA copy number in sentinel lymph node may be a powerful predictor of non-sentinel lymph node status in breast cancer patients.
title_fullStr A cut-off of 2150 cytokeratin 19 mRNA copy number in sentinel lymph node may be a powerful predictor of non-sentinel lymph node status in breast cancer patients.
title_full_unstemmed A cut-off of 2150 cytokeratin 19 mRNA copy number in sentinel lymph node may be a powerful predictor of non-sentinel lymph node status in breast cancer patients.
title_short A cut-off of 2150 cytokeratin 19 mRNA copy number in sentinel lymph node may be a powerful predictor of non-sentinel lymph node status in breast cancer patients.
title_sort cut off of 2150 cytokeratin 19 mrna copy number in sentinel lymph node may be a powerful predictor of non sentinel lymph node status in breast cancer patients
url https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0171517&type=printable
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