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

• 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 Publishing Group 2021-05-01
• Series: npj Breast Cancer
• Online Access: https://doi.org/10.1038/s41523-021-00246-4
• ISSN: 2374-4677

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.