Metadata supporting the published article: PONDx: Real-Life Utilization and Decision Impact of the 21-Gene Assay on Clinical Practice: in Italy
Creators: name: Cognetti, Francesco
name: Masetti, Riccardo
name: Fabi, Alessandra
name: Bianchi, Giulia
name: Santini, Donatella
name: Rognone, Alessia
name: Catania, Giovanna
name: Angelucci, Domenico
name: Naso, Giuseppe
name: Giuliano, Mario
name: Vassalli, Lucia
name: Vici, Patrizia
name: Scognamiglio, Giovanni
name: Generali, Daniele
name: Zambelli, Alberto
name: Colleoni, Marco
name: Tinterri, Corrado
name: Scanzi, Francesco
name: Vigna, Leonardo
name: Scavina, Paola
name: Gamucci, Teresa
name: Marrazzo, Emilia
name: Scinto, Angelo Fedele
name: Berardi, Rossana
name: Fabbri, Maria Agnese
name: Pinotti, Graziella
name: Franco, Daniela
name: Tonini, Giuseppe
name: Cianniello, Daniela
name: Barni, Sandro
Publisher: name: figshare
Year: 2021
Subjects: subject: Cancer
subject: 111203 Cancer Genetics
subject: FOS: Clinical medicine
subject: FOS: Clinical medicine
subject: 111204 Cancer Therapy (excl. Chemotherapy and Radiation Therapy)
subject: 111205 Chemotherapy
subject: Medicine

description: 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) 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.<br><b>Data access</b>: The datasets that support the findings of this study will be made available upon reasonable request from the corresponding author, Dr. Francesco Cognetti, email address: <b>francesco.cognetti@ifo.gov.it</b>. <br><b>Patient consent</b>: Patients provided written informed consent before participation in the study.<br><b>Study aims and methodology</b>: In this study, the authors describe the results of the multicenter, prospective, observational study, PONDx, which was performed in Italy from February 2016 to December 2017 and which investigated the real life use of the Oncotype DX Breast Recurrence Score® test by physicians treating early BC patients in routine care in clinical BC reference centers. The study primarily evaluated the impact of the Oncotype DX assay on physicians‘ treatment decisions. A further objective was the characterization of the patient population in which the test is used in real-life settings at clinical BC reference centers in Italy.Data from 1738 BC patients who underwent Oncotype DX testing were available from 27 reference centers located in six regions of Italy (Lombardia, Lazio, Emilia Romagna, Campania, Abruzzo, and Marche). In the present analysis, 14 patients were excluded due to incomplete data, leaving 1724 in the analysis cohort.Eligible patients fulfilled the validated criteria for use of the Oncotype DX assay: patients aged ≥18 years with a recent diagnosis of early single invasive ER+ HER2– BC and available information on lymph node involvement categorized as N0, Nmic (micrometastatic node involvement) or N1 (1-3 positive nodes). For details on the methodology, please read the related article.<br><b>Data supporting the published article: </b>Data supporting figure 1: Dataset <b>Cognetti FIGURE 1.xlsx</b> is in .xlsx file format.Data supporting figure 2: Dataset <b>Cognetti FIGURE 2.xlsx</b> is in .xlsx file format.Data supporting table 2: Dataset <b>Cognetti TABLE 2.xlsx</b> is in .xlsx file format, and includes patient and tumor characteristics in the overall population.Data supporting table 3: Dataset <b>Cognetti TABLE 3.xlsx</b> is in .xlsx file format, and includes the Oncotype DX Breast Recurrence Score® results.Data supporting table 4: Dataset <b>Cognetti TABLE 4.xlsx</b> is in .xlsx file format, and includes the recommendations by the treating physician.Data supporting table 5: Dataset <b>Cognetti TABLE 5.xlsx</b> is in .xlsx file format.<br>