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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Main Authors: 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
Format: Article
Language:English
Published: Nature Portfolio 2021-05-01
Series:npj Breast Cancer
Online Access:https://doi.org/10.1038/s41523-021-00246-4
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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
collection DOAJ
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.
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spelling doaj.art-a0a882fd09a64018b374c4f2f70cd8852023-12-02T14:14:15ZengNature Portfolionpj Breast Cancer2374-46772021-05-01711810.1038/s41523-021-00246-4PONDx: real-life utilization and decision impact of the 21-gene assay on clinical practice in ItalyFrancesco Cognetti0Riccardo Masetti1Alessandra Fabi2Giulia Bianchi3Donatella Santini4Alessia Rognone5Giovanna Catania6Domenico Angelucci7Giuseppe Naso8Mario Giuliano9Lucia Vassalli10Patrizia Vici11Giovanni Scognamiglio12Daniele Generali13Alberto Zambelli14Marco Colleoni15Corrado Tinterri16Francesco Scanzi17Leonardo Vigna18Paola Scavina19Teresa Gamucci20Emilia Marrazzo21Angelo Fedele Scinto22Rossana Berardi23Maria Agnese Fabbri24Graziella Pinotti25Daniela Franco26Daniela Andreina Terribile27Giuseppe Tonini28Daniela Cianniello29Sandro Barni30Università La Sapienza di Roma, Dipartimento Medicina Clinica e MolecolarePoliclinico Universitario Agostino Gemelli, IRCCSIRCCS Regina Elena National Cancer InstituteFondazione IRCCS Istituto Nazionale dei TumoriPoliclinico Sant’Orsola MalpighiOspedale San RaffaeleIRCCS Regina Elena National Cancer InstituteOspedale Gaetano BernabeoPoliclinico Umberto IAzienda Ospedaliera Universitaria Federico IIASST Spedali CiviliIRCCS Regina Elena National Cancer InstituteOspedale ValduceASST di CremonaASST Papa Giovanni XXIIIIstituto Europeo di OncologiaIstituto Clinico HumanitasIRCCS MultimedicaAzienda Ospedaliera San Camillo ForlaniniAzienda Ospedaliera San Giovanni - AddolorataOspedale SS. TrinitàIstituto Clinico HumanitasOspedale San Giovani Calibita FatebenefratelliAzienda Ospedaliero Universitaria Ospedali Riuniti di AnconaOspedale di BelcolleOspedale di Circolo e Fondazione MacchiOspedale Nuovo Regina MargheritaPoliclinico Universitario Agostino Gemelli, IRCCSPoliclinico Universitario Campus BiomedicoIstituto Nazionale Tumori Fondazione G. PascaleASST BG Ovest Ospedale TreviglioAbstract 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.https://doi.org/10.1038/s41523-021-00246-4
spellingShingle 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
npj Breast Cancer
title 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_short 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
url https://doi.org/10.1038/s41523-021-00246-4
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