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Elaboration of a nomogram to predict nonsentinel node status in breast cancer patients with positive sentinel node, intraoperatively assessed with one step nucleic amplification: Retrospective and validation phase

BACKGROUND: Tumor-positive sentinel lymph node (SLN) biopsy results in a risk of non sentinel node metastases in micro- and macro-metastases ranging from 20 to 50%, respectively. Therefore, most patients underwent unnecessary axillary lymph node dissections. We have previously developed a mathematic...

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Autores principales: Di Filippo, Franco, Di Filippo, Simona, Ferrari, Anna Maria, Antonetti, Raffaele, Battaglia, Alessandro, Becherini, Francesca, Bernet, Laia, Boldorini, Renzo, Bouteille, Catherine, Buglioni, Simonetta, Burelli, Paolo, Cano, Rafael, Canzonieri, Vincenzo, Chiodera, Pierluigi, Cirilli, Alfredo, Coppola, Luigi, Drago, Stefano, Di Tommaso, Luca, Fenaroli, Privato, Franchini, Roberto, Gianatti, Andrea, Giannarelli, Diana, Giardina, Carmela, Godey, Florence, Grassi, Massimo M., Grassi, Giuseppe B., Laws, Siobhan, Massarut, Samuele, Naccarato, Giuseppe, Natalicchio, Maria Iole, Orefice, Sergio, Palmieri, Fabrizio, Perin, Tiziana, Roncella, Manuela, Roncalli, Massimo G., Rulli, Antonio, Sidoni, Angelo, Tinterri, Corrado, Truglia, Maria C., Sperduti, Isabella
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5146809/
https://www.ncbi.nlm.nih.gov/pubmed/27931238
http://dx.doi.org/10.1186/s13046-016-0460-6
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author Di Filippo, Franco
Di Filippo, Simona
Ferrari, Anna Maria
Antonetti, Raffaele
Battaglia, Alessandro
Becherini, Francesca
Bernet, Laia
Boldorini, Renzo
Bouteille, Catherine
Buglioni, Simonetta
Burelli, Paolo
Cano, Rafael
Canzonieri, Vincenzo
Chiodera, Pierluigi
Cirilli, Alfredo
Coppola, Luigi
Drago, Stefano
Di Tommaso, Luca
Fenaroli, Privato
Franchini, Roberto
Gianatti, Andrea
Giannarelli, Diana
Giardina, Carmela
Godey, Florence
Grassi, Massimo M.
Grassi, Giuseppe B.
Laws, Siobhan
Massarut, Samuele
Naccarato, Giuseppe
Natalicchio, Maria Iole
Orefice, Sergio
Palmieri, Fabrizio
Perin, Tiziana
Roncella, Manuela
Roncalli, Massimo G.
Rulli, Antonio
Sidoni, Angelo
Tinterri, Corrado
Truglia, Maria C.
Sperduti, Isabella
author_facet Di Filippo, Franco
Di Filippo, Simona
Ferrari, Anna Maria
Antonetti, Raffaele
Battaglia, Alessandro
Becherini, Francesca
Bernet, Laia
Boldorini, Renzo
Bouteille, Catherine
Buglioni, Simonetta
Burelli, Paolo
Cano, Rafael
Canzonieri, Vincenzo
Chiodera, Pierluigi
Cirilli, Alfredo
Coppola, Luigi
Drago, Stefano
Di Tommaso, Luca
Fenaroli, Privato
Franchini, Roberto
Gianatti, Andrea
Giannarelli, Diana
Giardina, Carmela
Godey, Florence
Grassi, Massimo M.
Grassi, Giuseppe B.
Laws, Siobhan
Massarut, Samuele
Naccarato, Giuseppe
Natalicchio, Maria Iole
Orefice, Sergio
Palmieri, Fabrizio
Perin, Tiziana
Roncella, Manuela
Roncalli, Massimo G.
Rulli, Antonio
Sidoni, Angelo
Tinterri, Corrado
Truglia, Maria C.
Sperduti, Isabella
author_sort Di Filippo, Franco
collection PubMed
description BACKGROUND: Tumor-positive sentinel lymph node (SLN) biopsy results in a risk of non sentinel node metastases in micro- and macro-metastases ranging from 20 to 50%, respectively. Therefore, most patients underwent unnecessary axillary lymph node dissections. We have previously developed a mathematical model for predicting patient-specific risk of non sentinel node (NSN) metastases based on 2460 patients. The study reports the results of the validation phase where a total of 1945 patients were enrolled, aimed at identifying a tool that gives the possibility to the surgeon to choose intraoperatively whether to perform or not axillary lymph node dissection (ALND). METHODS: The following parameters were recorded: Clinical: hospital, age, medical record number; Bio pathological: Tumor (T) size stratified in quartiles, grading (G), histologic type, lymphatic/vascular invasion (LVI), ER-PR status, Ki 67, molecular classification (Luminal A, Luminal B, HER-2 Like, Triple negative); Sentinel and non-sentinel node related: Number of NSNs removed, number of positive NSNs, cytokeratin 19 (CK19) mRNA copy number of positive sentinel nodes stratified in quartiles. A total of 1945 patients were included in the database. All patient data were provided by the authors of this paper. RESULTS: The discrimination of the model quantified with the area under the receiver operating characteristics (ROC) curve (AUC), was 0.65 and 0.71 in the validation and retrospective phase, respectively. The calibration determines the distance between predicted outcome and actual outcome. The mean difference between predicted/observed was 2.3 and 6.3% in the retrospective and in the validation phase, respectively. The two values are quite similar and as a result we can conclude that the nomogram effectiveness was validated. Moreover, the ROC curve identified in the risk category of 31% of positive NSNs, the best compromise between false negative and positive rates i.e. when ALND is unnecessary (<31%) or recommended (>31%). CONCLUSIONS: The results of the study confirm that OSNA nomogram may help surgeons make an intraoperative decision on whether to perform ALND or not in case of positive sentinel nodes, and the patient to accept this decision based on a reliable estimation on the true percentage of NSN involvement. The use of this nomogram achieves two main gools: 1) the choice of the right treatment during the operation, 2) to avoid for the patient a second surgery procedure.
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spelling pubmed-51468092016-12-15 Elaboration of a nomogram to predict nonsentinel node status in breast cancer patients with positive sentinel node, intraoperatively assessed with one step nucleic amplification: Retrospective and validation phase Di Filippo, Franco Di Filippo, Simona Ferrari, Anna Maria Antonetti, Raffaele Battaglia, Alessandro Becherini, Francesca Bernet, Laia Boldorini, Renzo Bouteille, Catherine Buglioni, Simonetta Burelli, Paolo Cano, Rafael Canzonieri, Vincenzo Chiodera, Pierluigi Cirilli, Alfredo Coppola, Luigi Drago, Stefano Di Tommaso, Luca Fenaroli, Privato Franchini, Roberto Gianatti, Andrea Giannarelli, Diana Giardina, Carmela Godey, Florence Grassi, Massimo M. Grassi, Giuseppe B. Laws, Siobhan Massarut, Samuele Naccarato, Giuseppe Natalicchio, Maria Iole Orefice, Sergio Palmieri, Fabrizio Perin, Tiziana Roncella, Manuela Roncalli, Massimo G. Rulli, Antonio Sidoni, Angelo Tinterri, Corrado Truglia, Maria C. Sperduti, Isabella J Exp Clin Cancer Res Research BACKGROUND: Tumor-positive sentinel lymph node (SLN) biopsy results in a risk of non sentinel node metastases in micro- and macro-metastases ranging from 20 to 50%, respectively. Therefore, most patients underwent unnecessary axillary lymph node dissections. We have previously developed a mathematical model for predicting patient-specific risk of non sentinel node (NSN) metastases based on 2460 patients. The study reports the results of the validation phase where a total of 1945 patients were enrolled, aimed at identifying a tool that gives the possibility to the surgeon to choose intraoperatively whether to perform or not axillary lymph node dissection (ALND). METHODS: The following parameters were recorded: Clinical: hospital, age, medical record number; Bio pathological: Tumor (T) size stratified in quartiles, grading (G), histologic type, lymphatic/vascular invasion (LVI), ER-PR status, Ki 67, molecular classification (Luminal A, Luminal B, HER-2 Like, Triple negative); Sentinel and non-sentinel node related: Number of NSNs removed, number of positive NSNs, cytokeratin 19 (CK19) mRNA copy number of positive sentinel nodes stratified in quartiles. A total of 1945 patients were included in the database. All patient data were provided by the authors of this paper. RESULTS: The discrimination of the model quantified with the area under the receiver operating characteristics (ROC) curve (AUC), was 0.65 and 0.71 in the validation and retrospective phase, respectively. The calibration determines the distance between predicted outcome and actual outcome. The mean difference between predicted/observed was 2.3 and 6.3% in the retrospective and in the validation phase, respectively. The two values are quite similar and as a result we can conclude that the nomogram effectiveness was validated. Moreover, the ROC curve identified in the risk category of 31% of positive NSNs, the best compromise between false negative and positive rates i.e. when ALND is unnecessary (<31%) or recommended (>31%). CONCLUSIONS: The results of the study confirm that OSNA nomogram may help surgeons make an intraoperative decision on whether to perform ALND or not in case of positive sentinel nodes, and the patient to accept this decision based on a reliable estimation on the true percentage of NSN involvement. The use of this nomogram achieves two main gools: 1) the choice of the right treatment during the operation, 2) to avoid for the patient a second surgery procedure. BioMed Central 2016-12-08 /pmc/articles/PMC5146809/ /pubmed/27931238 http://dx.doi.org/10.1186/s13046-016-0460-6 Text en © The Author(s). 2016 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Research
Di Filippo, Franco
Di Filippo, Simona
Ferrari, Anna Maria
Antonetti, Raffaele
Battaglia, Alessandro
Becherini, Francesca
Bernet, Laia
Boldorini, Renzo
Bouteille, Catherine
Buglioni, Simonetta
Burelli, Paolo
Cano, Rafael
Canzonieri, Vincenzo
Chiodera, Pierluigi
Cirilli, Alfredo
Coppola, Luigi
Drago, Stefano
Di Tommaso, Luca
Fenaroli, Privato
Franchini, Roberto
Gianatti, Andrea
Giannarelli, Diana
Giardina, Carmela
Godey, Florence
Grassi, Massimo M.
Grassi, Giuseppe B.
Laws, Siobhan
Massarut, Samuele
Naccarato, Giuseppe
Natalicchio, Maria Iole
Orefice, Sergio
Palmieri, Fabrizio
Perin, Tiziana
Roncella, Manuela
Roncalli, Massimo G.
Rulli, Antonio
Sidoni, Angelo
Tinterri, Corrado
Truglia, Maria C.
Sperduti, Isabella
Elaboration of a nomogram to predict nonsentinel node status in breast cancer patients with positive sentinel node, intraoperatively assessed with one step nucleic amplification: Retrospective and validation phase
title Elaboration of a nomogram to predict nonsentinel node status in breast cancer patients with positive sentinel node, intraoperatively assessed with one step nucleic amplification: Retrospective and validation phase
title_full Elaboration of a nomogram to predict nonsentinel node status in breast cancer patients with positive sentinel node, intraoperatively assessed with one step nucleic amplification: Retrospective and validation phase
title_fullStr Elaboration of a nomogram to predict nonsentinel node status in breast cancer patients with positive sentinel node, intraoperatively assessed with one step nucleic amplification: Retrospective and validation phase
title_full_unstemmed Elaboration of a nomogram to predict nonsentinel node status in breast cancer patients with positive sentinel node, intraoperatively assessed with one step nucleic amplification: Retrospective and validation phase
title_short Elaboration of a nomogram to predict nonsentinel node status in breast cancer patients with positive sentinel node, intraoperatively assessed with one step nucleic amplification: Retrospective and validation phase
title_sort elaboration of a nomogram to predict nonsentinel node status in breast cancer patients with positive sentinel node, intraoperatively assessed with one step nucleic amplification: retrospective and validation phase
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5146809/
https://www.ncbi.nlm.nih.gov/pubmed/27931238
http://dx.doi.org/10.1186/s13046-016-0460-6
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