npj Breast Cancer (May 2021)

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

  • 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

DOI
https://doi.org/10.1038/s41523-021-00246-4
Journal volume & issue
Vol. 7, no. 1
pp. 1 – 8

Abstract

Read online

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.