The promher study: An observational Italian study on adjuvant therapy for her2-positive, pT1a-b pN0 breast cancer

Stefania Gori; Alessandro Inno; Elena Fiorio; Jennifer Foglietta; Antonella Ferro; Marcella Gulisano; Graziella Pinotti; Marta Gubiotti; Maria Giovanna Cavazzini; Monica Turazza; Simona Duranti; Valeria De Simone; Laura Iezzi; Giancarlo Bisagni; Simon Spazzapan; Luigi Cavanna; Chiara Saggia; Emilio Bria; Elisabetta Cretella; Patrizia Vici; Daniele Santini; Alessandra Fabi; Ornella Garrone; Antonio Frassoldati; Laura Amaducci; Silvana Saracchini; Lucia Evangelisti; Sandro Barni; Teresa Gamucci; Lucia Mentuccia; Lucio Laudadio; Alessandra Zoboli; Fabiana Marchetti; Giuseppe Bogina; Gianluigi Lunardi; Luca Boni

doi:10.1371/journal.pone.0136731

The promher study: An observational Italian study on adjuvant therapy for her2-positive, pT1a-b pN0 breast cancer

Stefania Gori, Alessandro Inno, Elena Fiorio, Jennifer Foglietta, Antonella Ferro, Marcella Gulisano, Graziella Pinotti, Marta Gubiotti, Maria Giovanna Cavazzini, Monica Turazza, Simona Duranti, Valeria De Simone, Laura Iezzi, Giancarlo Bisagni, Simon Spazzapan, Luigi Cavanna, Chiara Saggia, Emilio Bria, Elisabetta Cretella, Patrizia ViciDaniele Santini, Alessandra Fabi, Ornella Garrone, Antonio Frassoldati, Laura Amaducci, Silvana Saracchini, Lucia Evangelisti, Sandro Barni, Teresa Gamucci, Lucia Mentuccia, Lucio Laudadio, Alessandra Zoboli, Fabiana Marchetti, Giuseppe Bogina, Gianluigi Lunardi, Luca Boni

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Abstract

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 28Italian 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

Original language	English
Article number	e0136731
Journal	PLoS One
Volume	10
Issue number	9
DOIs	https://doi.org/10.1371/journal.pone.0136731
Publication status	Published - Sep 4 2015

ASJC Scopus subject areas

Agricultural and Biological Sciences(all)
Biochemistry, Genetics and Molecular Biology(all)
Medicine(all)

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10.1371/journal.pone.0136731

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Gori, S., Inno, A., Fiorio, E., Foglietta, J., Ferro, A., Gulisano, M., Pinotti, G., Gubiotti, M., Cavazzini, M. G., Turazza, M., Duranti, S., De Simone, V., Iezzi, L., Bisagni, G., Spazzapan, S., Cavanna, L., Saggia, C., Bria, E., Cretella, E., ... Boni, L. (2015). The promher study: An observational Italian study on adjuvant therapy for her2-positive, pT1a-b pN0 breast cancer. PLoS One, 10(9), [e0136731]. https://doi.org/10.1371/journal.pone.0136731

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.

In: PLoS One, Vol. 10, No. 9, e0136731, 04.09.2015.

Research output: Contribution to journal › Article › peer-review

Gori, S, Inno, A, Fiorio, E, Foglietta, J, Ferro, A, Gulisano, M, Pinotti, G, Gubiotti, M, Cavazzini, MG, Turazza, M, Duranti, S, De Simone, V, Iezzi, L, Bisagni, G , Spazzapan, S, Cavanna, L, Saggia, C, Bria, E, Cretella, E, Vici, P, Santini, D, Fabi, A, Garrone, O, Frassoldati, A, Amaducci, L, Saracchini, S, Evangelisti, L, Barni, S, Gamucci, T, Mentuccia, L, Laudadio, L, Zoboli, A, Marchetti, F, Bogina, G, Lunardi, G & Boni, L 2015, 'The promher study: An observational Italian study on adjuvant therapy for her2-positive, pT1a-b pN0 breast cancer', PLoS One, vol. 10, no. 9, e0136731. https://doi.org/10.1371/journal.pone.0136731

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. In: PLoS One. 2015 ; Vol. 10, No. 9.

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title = "The promher study: An observational Italian study on adjuvant therapy for her2-positive, pT1a-b pN0 breast cancer",

abstract = "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 28Italian 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",

author = "Stefania Gori and Alessandro Inno and Elena Fiorio and Jennifer Foglietta and Antonella Ferro and Marcella Gulisano and Graziella Pinotti and Marta Gubiotti and Cavazzini, {Maria Giovanna} and Monica Turazza and Simona Duranti and {De Simone}, Valeria and Laura Iezzi and Giancarlo Bisagni and Simon Spazzapan and Luigi Cavanna and Chiara Saggia and Emilio Bria and Elisabetta Cretella and Patrizia Vici and Daniele Santini and Alessandra Fabi and Ornella Garrone and Antonio Frassoldati and Laura Amaducci and Silvana Saracchini and Lucia Evangelisti and Sandro Barni and Teresa Gamucci and Lucia Mentuccia and Lucio Laudadio and Alessandra Zoboli and Fabiana Marchetti and Giuseppe Bogina and Gianluigi Lunardi and Luca Boni",

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T2 - An observational Italian study on adjuvant therapy for her2-positive, pT1a-b pN0 breast cancer

AU - Gori, Stefania

AU - Inno, Alessandro

AU - Fiorio, Elena

AU - Foglietta, Jennifer

AU - Ferro, Antonella

AU - Gulisano, Marcella

AU - Pinotti, Graziella

AU - Gubiotti, Marta

AU - Cavazzini, Maria Giovanna

AU - Turazza, Monica

AU - Duranti, Simona

AU - De Simone, Valeria

AU - Iezzi, Laura

AU - Bisagni, Giancarlo

AU - Spazzapan, Simon

AU - Cavanna, Luigi

AU - Saggia, Chiara

AU - Bria, Emilio

AU - Cretella, Elisabetta

AU - Vici, Patrizia

AU - Santini, Daniele

AU - Fabi, Alessandra

AU - Garrone, Ornella

AU - Frassoldati, Antonio

AU - Amaducci, Laura

AU - Saracchini, Silvana

AU - Evangelisti, Lucia

AU - Barni, Sandro

AU - Gamucci, Teresa

AU - Mentuccia, Lucia

AU - Laudadio, Lucio

AU - Zoboli, Alessandra

AU - Marchetti, Fabiana

AU - Bogina, Giuseppe

AU - Lunardi, Gianluigi

AU - Boni, Luca

PY - 2015/9/4

Y1 - 2015/9/4

N2 - 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 28Italian 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

AB - 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 28Italian 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

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The promher study: An observational Italian study on adjuvant therapy for her2-positive, pT1a-b pN0 breast cancer

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