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The Promher Study: An Observational Italian Study on Adjuvant Therapy for HER2-Positive, pT1a-b pN0 Breast Cancer

BACKGROUND: The management of pT1a-b pN0 HER2-positive breast cancer is controversial and no data about the efficacy of trastuzumab in this setting are available from randomized clinical trials. The aims of this retrospective study were to assess how patients are managed in clinical practice in Ital...

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Autores principales: Gori, Stefania, Inno, Alessandro, Fiorio, Elena, Foglietta, Jennifer, Ferro, Antonella, Gulisano, Marcella, Pinotti, Graziella, Gubiotti, Marta, Cavazzini, Maria Giovanna, Turazza, Monica, Duranti, Simona, De Simone, Valeria, Iezzi, Laura, Bisagni, Giancarlo, Spazzapan, Simon, Cavanna, Luigi, Saggia, Chiara, Bria, Emilio, Cretella, Elisabetta, Vici, Patrizia, Santini, Daniele, Fabi, Alessandra, Garrone, Ornella, Frassoldati, Antonio, Amaducci, Laura, Saracchini, Silvana, Evangelisti, Lucia, Barni, Sandro, Gamucci, Teresa, Mentuccia, Lucia, Laudadio, Lucio, Zoboli, Alessandra, Marchetti, Fabiana, Bogina, Giuseppe, Lunardi, Gianluigi, Boni, Luca
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4560419/
https://www.ncbi.nlm.nih.gov/pubmed/26340098
http://dx.doi.org/10.1371/journal.pone.0136731
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author Gori, Stefania
Inno, Alessandro
Fiorio, Elena
Foglietta, Jennifer
Ferro, Antonella
Gulisano, Marcella
Pinotti, Graziella
Gubiotti, Marta
Cavazzini, Maria Giovanna
Turazza, Monica
Duranti, Simona
De Simone, Valeria
Iezzi, Laura
Bisagni, Giancarlo
Spazzapan, Simon
Cavanna, Luigi
Saggia, Chiara
Bria, Emilio
Cretella, Elisabetta
Vici, Patrizia
Santini, Daniele
Fabi, Alessandra
Garrone, Ornella
Frassoldati, Antonio
Amaducci, Laura
Saracchini, Silvana
Evangelisti, Lucia
Barni, Sandro
Gamucci, Teresa
Mentuccia, Lucia
Laudadio, Lucio
Zoboli, Alessandra
Marchetti, Fabiana
Bogina, Giuseppe
Lunardi, Gianluigi
Boni, Luca
author_facet Gori, Stefania
Inno, Alessandro
Fiorio, Elena
Foglietta, Jennifer
Ferro, Antonella
Gulisano, Marcella
Pinotti, Graziella
Gubiotti, Marta
Cavazzini, Maria Giovanna
Turazza, Monica
Duranti, Simona
De Simone, Valeria
Iezzi, Laura
Bisagni, Giancarlo
Spazzapan, Simon
Cavanna, Luigi
Saggia, Chiara
Bria, Emilio
Cretella, Elisabetta
Vici, Patrizia
Santini, Daniele
Fabi, Alessandra
Garrone, Ornella
Frassoldati, Antonio
Amaducci, Laura
Saracchini, Silvana
Evangelisti, Lucia
Barni, Sandro
Gamucci, Teresa
Mentuccia, Lucia
Laudadio, Lucio
Zoboli, Alessandra
Marchetti, Fabiana
Bogina, Giuseppe
Lunardi, Gianluigi
Boni, Luca
author_sort Gori, Stefania
collection PubMed
description BACKGROUND: The management of pT1a-b pN0 HER2-positive breast cancer is controversial and no data about the efficacy of trastuzumab in this setting are available from randomized clinical trials. The aims of this retrospective study were to assess how patients are managed in clinical practice in Italy, which clinical or biological characteristics influenced the choice of adjuvant systemic therapy and the outcome of patients. METHODS: Data of consecutive patients who underwent surgery from January 2007 to December 2012 for HER2-positive, pT1a-b pN0 M0 breast cancer were retrospectively collected from 28 Italian centres. Analysis of contingency tables and multivariate generalized logit models were used to investigate the association between the baseline clinical and biological features and the treatment strategy adopted. RESULTS: Among 303 enrolled patients, 204 received adjuvant systemic therapy with trastuzumab, 65 adjuvant systemic therapy without trastuzumab and 34 did not receive adjuvant systemic therapy. At the multivariate analysis age, tumor size, proliferation index and hormone receptor status were significantly associated with the treatment choice. Five-year disease-free survival (DFS) probability was 95%, 94.3% and 69.6% for patients treated with adjuvant systemic therapy and trastuzumab, with adjuvant systemic therapy without trastuzumab and for patients who did not receive adjuvant systemic therapy, respectively (p<0.001). CONCLUSIONS: The majority of patients (66%) with pT1a-b pN0 HER2-positive breast cancer enrolled in this retrospective study received adjuvant systemic therapy with trastuzumab, whereas only 11% patients did not receive any adjuvant systemic therapy. The choice of treatment type seems to be mainly influenced by tumor size, proliferation index, hormone receptor status and age. The 5-year DFS probability was significantly higher for patients receiving adjuvant systemic therapy with trastuzumab compared with patients not receiving adjuvant systemic therapy or receiving adjuvant systemic therapy without trastuzumab.
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spelling pubmed-45604192015-09-10 The Promher Study: An Observational Italian Study on Adjuvant Therapy for HER2-Positive, pT1a-b pN0 Breast Cancer Gori, Stefania Inno, Alessandro Fiorio, Elena Foglietta, Jennifer Ferro, Antonella Gulisano, Marcella Pinotti, Graziella Gubiotti, Marta Cavazzini, Maria Giovanna Turazza, Monica Duranti, Simona De Simone, Valeria Iezzi, Laura Bisagni, Giancarlo Spazzapan, Simon Cavanna, Luigi Saggia, Chiara Bria, Emilio Cretella, Elisabetta Vici, Patrizia Santini, Daniele Fabi, Alessandra Garrone, Ornella Frassoldati, Antonio Amaducci, Laura Saracchini, Silvana Evangelisti, Lucia Barni, Sandro Gamucci, Teresa Mentuccia, Lucia Laudadio, Lucio Zoboli, Alessandra Marchetti, Fabiana Bogina, Giuseppe Lunardi, Gianluigi Boni, Luca PLoS One Research Article BACKGROUND: The management of pT1a-b pN0 HER2-positive breast cancer is controversial and no data about the efficacy of trastuzumab in this setting are available from randomized clinical trials. The aims of this retrospective study were to assess how patients are managed in clinical practice in Italy, which clinical or biological characteristics influenced the choice of adjuvant systemic therapy and the outcome of patients. METHODS: Data of consecutive patients who underwent surgery from January 2007 to December 2012 for HER2-positive, pT1a-b pN0 M0 breast cancer were retrospectively collected from 28 Italian centres. Analysis of contingency tables and multivariate generalized logit models were used to investigate the association between the baseline clinical and biological features and the treatment strategy adopted. RESULTS: Among 303 enrolled patients, 204 received adjuvant systemic therapy with trastuzumab, 65 adjuvant systemic therapy without trastuzumab and 34 did not receive adjuvant systemic therapy. At the multivariate analysis age, tumor size, proliferation index and hormone receptor status were significantly associated with the treatment choice. Five-year disease-free survival (DFS) probability was 95%, 94.3% and 69.6% for patients treated with adjuvant systemic therapy and trastuzumab, with adjuvant systemic therapy without trastuzumab and for patients who did not receive adjuvant systemic therapy, respectively (p<0.001). CONCLUSIONS: The majority of patients (66%) with pT1a-b pN0 HER2-positive breast cancer enrolled in this retrospective study received adjuvant systemic therapy with trastuzumab, whereas only 11% patients did not receive any adjuvant systemic therapy. The choice of treatment type seems to be mainly influenced by tumor size, proliferation index, hormone receptor status and age. The 5-year DFS probability was significantly higher for patients receiving adjuvant systemic therapy with trastuzumab compared with patients not receiving adjuvant systemic therapy or receiving adjuvant systemic therapy without trastuzumab. Public Library of Science 2015-09-04 /pmc/articles/PMC4560419/ /pubmed/26340098 http://dx.doi.org/10.1371/journal.pone.0136731 Text en © 2015 Gori et al http://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are properly credited.
spellingShingle Research Article
Gori, Stefania
Inno, Alessandro
Fiorio, Elena
Foglietta, Jennifer
Ferro, Antonella
Gulisano, Marcella
Pinotti, Graziella
Gubiotti, Marta
Cavazzini, Maria Giovanna
Turazza, Monica
Duranti, Simona
De Simone, Valeria
Iezzi, Laura
Bisagni, Giancarlo
Spazzapan, Simon
Cavanna, Luigi
Saggia, Chiara
Bria, Emilio
Cretella, Elisabetta
Vici, Patrizia
Santini, Daniele
Fabi, Alessandra
Garrone, Ornella
Frassoldati, Antonio
Amaducci, Laura
Saracchini, Silvana
Evangelisti, Lucia
Barni, Sandro
Gamucci, Teresa
Mentuccia, Lucia
Laudadio, Lucio
Zoboli, Alessandra
Marchetti, Fabiana
Bogina, Giuseppe
Lunardi, Gianluigi
Boni, Luca
The Promher Study: An Observational Italian Study on Adjuvant Therapy for HER2-Positive, pT1a-b pN0 Breast Cancer
title The Promher Study: An Observational Italian Study on Adjuvant Therapy for HER2-Positive, pT1a-b pN0 Breast Cancer
title_full The Promher Study: An Observational Italian Study on Adjuvant Therapy for HER2-Positive, pT1a-b pN0 Breast Cancer
title_fullStr The Promher Study: An Observational Italian Study on Adjuvant Therapy for HER2-Positive, pT1a-b pN0 Breast Cancer
title_full_unstemmed The Promher Study: An Observational Italian Study on Adjuvant Therapy for HER2-Positive, pT1a-b pN0 Breast Cancer
title_short The Promher Study: An Observational Italian Study on Adjuvant Therapy for HER2-Positive, pT1a-b pN0 Breast Cancer
title_sort promher study: an observational italian study on adjuvant therapy for her2-positive, pt1a-b pn0 breast cancer
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4560419/
https://www.ncbi.nlm.nih.gov/pubmed/26340098
http://dx.doi.org/10.1371/journal.pone.0136731
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