PONDx: real-life utilization and decision impact of the 21-gene assay on clinical practice in Italy

Abstract Clinicopathological prognostic features have limited value to identify with precision newly diagnosed patients with hormone receptor (HR)-positive, HER2-negative breast cancer (BC), who would benefit from chemotherapy (CT) in addition to adjuvant hormonal therapy (HT). The 21-gene Oncotype...

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Autores principales: Francesco Cognetti, Riccardo Masetti, Alessandra Fabi, Giulia Bianchi, Donatella Santini, Alessia Rognone, Giovanna Catania, Domenico Angelucci, Giuseppe Naso, Mario Giuliano, Lucia Vassalli, Patrizia Vici, Giovanni Scognamiglio, Daniele Generali, Alberto Zambelli, Marco Colleoni, Corrado Tinterri, Francesco Scanzi, Leonardo Vigna, Paola Scavina, Teresa Gamucci, Emilia Marrazzo, Angelo Fedele Scinto, Rossana Berardi, Maria Agnese Fabbri, Graziella Pinotti, Daniela Franco, Daniela Andreina Terribile, Giuseppe Tonini, Daniela Cianniello, Sandro Barni
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Publicado: Nature Portfolio 2021
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Acceso en línea:https://doaj.org/article/a0a882fd09a64018b374c4f2f70cd885
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spelling oai:doaj.org-article:a0a882fd09a64018b374c4f2f70cd8852021-12-02T14:41:54ZPONDx: real-life utilization and decision impact of the 21-gene assay on clinical practice in Italy10.1038/s41523-021-00246-42374-4677https://doaj.org/article/a0a882fd09a64018b374c4f2f70cd8852021-05-01T00:00:00Zhttps://doi.org/10.1038/s41523-021-00246-4https://doaj.org/toc/2374-4677Abstract Clinicopathological prognostic features have limited value to identify with precision newly diagnosed patients with hormone receptor (HR)-positive, HER2-negative breast cancer (BC), who would benefit from chemotherapy (CT) in addition to adjuvant hormonal therapy (HT). The 21-gene Oncotype DX Breast Recurrence Score® (RS) assay has been demonstrated to predict CT benefit, hence supporting personalized decisions on adjuvant CT. The multicenter, prospective, observational study PONDx investigated the real-life use of RS® results in Italy and its impact on treatment decisions. Physicians’ treatment recommendations (HT ± CT) were documented before and after availability of RS results, and changes in recommendations were determined. In the HR+ HER2− early BC population studied (N = 1738), physicians recommended CT + HT in 49% of patients pre-RS. RS-guided treatment decisions resulted in 36% reduction of CT recommendations. PONDx confirms that RS results provide clinically relevant information for CT recommendation in early-stage BC, resulting in a reduction of more than a third of CT use.Francesco CognettiRiccardo MasettiAlessandra FabiGiulia BianchiDonatella SantiniAlessia RognoneGiovanna CataniaDomenico AngelucciGiuseppe NasoMario GiulianoLucia VassalliPatrizia ViciGiovanni ScognamiglioDaniele GeneraliAlberto ZambelliMarco ColleoniCorrado TinterriFrancesco ScanziLeonardo VignaPaola ScavinaTeresa GamucciEmilia MarrazzoAngelo Fedele ScintoRossana BerardiMaria Agnese FabbriGraziella PinottiDaniela FrancoDaniela Andreina TerribileGiuseppe ToniniDaniela CiannielloSandro BarniNature PortfolioarticleNeoplasms. Tumors. Oncology. Including cancer and carcinogensRC254-282ENnpj Breast Cancer, Vol 7, Iss 1, Pp 1-8 (2021)
institution DOAJ
collection DOAJ
language EN
topic Neoplasms. Tumors. Oncology. Including cancer and carcinogens
RC254-282
spellingShingle Neoplasms. Tumors. Oncology. Including cancer and carcinogens
RC254-282
Francesco Cognetti
Riccardo Masetti
Alessandra Fabi
Giulia Bianchi
Donatella Santini
Alessia Rognone
Giovanna Catania
Domenico Angelucci
Giuseppe Naso
Mario Giuliano
Lucia Vassalli
Patrizia Vici
Giovanni Scognamiglio
Daniele Generali
Alberto Zambelli
Marco Colleoni
Corrado Tinterri
Francesco Scanzi
Leonardo Vigna
Paola Scavina
Teresa Gamucci
Emilia Marrazzo
Angelo Fedele Scinto
Rossana Berardi
Maria Agnese Fabbri
Graziella Pinotti
Daniela Franco
Daniela Andreina Terribile
Giuseppe Tonini
Daniela Cianniello
Sandro Barni
PONDx: real-life utilization and decision impact of the 21-gene assay on clinical practice in Italy
description Abstract Clinicopathological prognostic features have limited value to identify with precision newly diagnosed patients with hormone receptor (HR)-positive, HER2-negative breast cancer (BC), who would benefit from chemotherapy (CT) in addition to adjuvant hormonal therapy (HT). The 21-gene Oncotype DX Breast Recurrence Score® (RS) assay has been demonstrated to predict CT benefit, hence supporting personalized decisions on adjuvant CT. The multicenter, prospective, observational study PONDx investigated the real-life use of RS® results in Italy and its impact on treatment decisions. Physicians’ treatment recommendations (HT ± CT) were documented before and after availability of RS results, and changes in recommendations were determined. In the HR+ HER2− early BC population studied (N = 1738), physicians recommended CT + HT in 49% of patients pre-RS. RS-guided treatment decisions resulted in 36% reduction of CT recommendations. PONDx confirms that RS results provide clinically relevant information for CT recommendation in early-stage BC, resulting in a reduction of more than a third of CT use.
format article
author Francesco Cognetti
Riccardo Masetti
Alessandra Fabi
Giulia Bianchi
Donatella Santini
Alessia Rognone
Giovanna Catania
Domenico Angelucci
Giuseppe Naso
Mario Giuliano
Lucia Vassalli
Patrizia Vici
Giovanni Scognamiglio
Daniele Generali
Alberto Zambelli
Marco Colleoni
Corrado Tinterri
Francesco Scanzi
Leonardo Vigna
Paola Scavina
Teresa Gamucci
Emilia Marrazzo
Angelo Fedele Scinto
Rossana Berardi
Maria Agnese Fabbri
Graziella Pinotti
Daniela Franco
Daniela Andreina Terribile
Giuseppe Tonini
Daniela Cianniello
Sandro Barni
author_facet Francesco Cognetti
Riccardo Masetti
Alessandra Fabi
Giulia Bianchi
Donatella Santini
Alessia Rognone
Giovanna Catania
Domenico Angelucci
Giuseppe Naso
Mario Giuliano
Lucia Vassalli
Patrizia Vici
Giovanni Scognamiglio
Daniele Generali
Alberto Zambelli
Marco Colleoni
Corrado Tinterri
Francesco Scanzi
Leonardo Vigna
Paola Scavina
Teresa Gamucci
Emilia Marrazzo
Angelo Fedele Scinto
Rossana Berardi
Maria Agnese Fabbri
Graziella Pinotti
Daniela Franco
Daniela Andreina Terribile
Giuseppe Tonini
Daniela Cianniello
Sandro Barni
author_sort Francesco Cognetti
title PONDx: real-life utilization and decision impact of the 21-gene assay on clinical practice in Italy
title_short PONDx: real-life utilization and decision impact of the 21-gene assay on clinical practice in Italy
title_full PONDx: real-life utilization and decision impact of the 21-gene assay on clinical practice in Italy
title_fullStr PONDx: real-life utilization and decision impact of the 21-gene assay on clinical practice in Italy
title_full_unstemmed PONDx: real-life utilization and decision impact of the 21-gene assay on clinical practice in Italy
title_sort pondx: real-life utilization and decision impact of the 21-gene assay on clinical practice in italy
publisher Nature Portfolio
publishDate 2021
url https://doaj.org/article/a0a882fd09a64018b374c4f2f70cd885
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