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. 2021 May 5;7(1):47.
doi: 10.1038/s41523-021-00246-4.

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

Francesco Cognetti  1 , Riccardo Masetti  2 , Alessandra Fabi  3 , Giulia Bianchi  4 , Donatella Santini  5 , Alessia Rognone  6 , Giovanna Catania  3 , Domenico Angelucci  7 , Giuseppe Naso  8 , Mario Giuliano  9 , Lucia Vassalli  10 , Patrizia Vici  11 , Giovanni Scognamiglio  12 , Daniele Generali  13 , Alberto Zambelli  14 , Marco Colleoni  15 , Corrado Tinterri  16 , Francesco Scanzi  17 , Leonardo Vigna  18 , Paola Scavina  19 , Teresa Gamucci  20 , Emilia Marrazzo  16 , Angelo Fedele Scinto  21 , Rossana Berardi  22 , Maria Agnese Fabbri  23 , Graziella Pinotti  24 , Daniela Franco  25 , Daniela Andreina Terribile  2 , Giuseppe Tonini  26 , Daniela Cianniello  27 , Sandro Barni  28
Affiliations

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

Francesco Cognetti et al. NPJ Breast Cancer. .

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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Conflict of interest statement

F.C.: Genomic Health, Inc., Roche, Eli Lilly, Bayer, Novartis, Amgen, Pfizer, Astra Zeneca, Eisai, Merch-Serono, Boheringer Ingelheim, MSD, BMS, Takeda, Astellas Oncology, Abbott. S.B.: Genomic Health, Inc. A.F.: Roche, Celgene, Astra Zeneca, Eli Lilly, Novartis, Pfizer, Eisai. M.G.: Roche, Pfizer, Astra Zeneca, Novartis, Celgene, Eli, Lilly, Amgen, and Eisai. M.C.: Novartis, Pierre Fabre, Pfizer, OBI Pharma, Puma Biotechnology, Celldex, Astra zeneca. A.Z.: Roche, Astra Zeneca, Novartis, Eli Lilly, Pfizer. D.G.: Eli Lilly, Novartis, Pfizer, Eisai. D.A.: Genomic Health, Inc. G.N.: Pfizer, Genomic Health, Inc., Italfarmaco. P.V.: Eisai, Roche, Pfizer, Novartis, Gentili. D.C.: Novartis, Roche. G.B.: Eli Lilly, Novartis. G.T.: Novartis Pfizer Italfarmaco e Molteni. T.G.: Novartis Roche Celgine Pfeizer Lilly Gentili. G.C., R.M., D.F., A.R., P.S., F.S., L. Vigna, C.T., D.S., M.A.F., E.M., G.S., G.P., A.F.S., R.B., and L. Vassalli declare no competing interests.

Figures

Fig. 1
Fig. 1. Changes in treatment recommendations before and after availability of the Recurrence Score result.
Rates of hormone therapy alone (HT) or chemo-endocrine therapy (CT+HT) recommendations before testing (Pre RS) and changes in recommendations based on the test resutls (Post RS).
Fig. 2
Fig. 2. Patients with post-RS recommendations for chemo-endocriine therapy (CT + HT): actual number based on previous RS cut points and expected percentage assuming decision-making according to TAILORx results (N = 1683).
Pre RS: treatment recommendations before avalability of the Recurrence Score result. Post RS: treatment recommendations accounting for the Recurrence Score result.
See this image and copyright information in PMC

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