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Observational Study
. 2019 Apr:44:39-45.
doi: 10.1016/j.breast.2018.12.015. Epub 2019 Jan 3.

Results of PONDx, a prospective multicenter study of the Oncotype DX® breast cancer assay: Real-life utilization and decision impact in French clinical practice

Elsa Curtit  1 , Jean-Michel Vannetzel  2 , Jean-Claude Darmon  3 , Sophie Roche  4 , Hugues Bourgeois  5 , Sylvain Dewas  6 , Stéphanie Catala  7 , Emile Mereb  8 , Charlotte Furtos Fanget  9 , Dominique Genet  10 , Anne-Marie Forest  11 , Céline Bernier  12 , Xavier Pivot  13
Affiliations
Observational Study

Results of PONDx, a prospective multicenter study of the Oncotype DX® breast cancer assay: Real-life utilization and decision impact in French clinical practice

Elsa Curtit et al. Breast. 2019 Apr.

Abstract

Adjuvant chemotherapy shows clear benefits in HER2-positive and triple-negative breast cancer (BC). Its benefits are less universal in BCs expressing hormone receptors. The 21-gene Oncotype DX® Breast Recurrence Score test was designed for HR+, HER2- early-stage BC before decision on adjuvant chemotherapy. Its validity and utility was demonstrated prospectively across multiple studies. The observational study PONDx characterized the use of Oncotype DX® Breast in routine practice in France and evaluated its decision impact. Of 882 ER-positive BC patients (67% postmenopausal), most (79%) had N0/Nmic node involvement, grade 2 tumors (68%), tumor size 1-5 cm (88%), and ductal histology (78%). BCs with histopathologically elevated recurrence risk included grade 3: 18%; N1: 21%; Ki67 > 20%: 31%. Recurrence Score results by prognostic category were: <18: 54%, 18-30: 36%; >30: 10%. Compared to recommendations before individual availability of the score, results prompted net absolute reductions in chemotherapy recommendations of 36% (total population), and 29% (grade 3 and/or Ki67 > 20% histologies). Decisions reflected prognostic implications: in the Recurrence Score <18 category, 95% of patients received recommendations of hormonal therapy only, in the >30 category, 97.5% were recommended additional chemotherapy; 95% followed the final recommendations of their physicians. The Recurrence Score provides independent predictive and prognostic information in ER + N0/N1 early BC, including high-risk subgroups. PONDx further characterizes the population where the test is beneficial in real-life use and fits current clinical needs. Oncotype DX® Breast enables relevant net reductions in chemotherapy use, sparing patients from serious toxicities. Its therapeutic implications are highly accepted by physicians and patients.

Keywords: 21-Gene; Adjuvant therapy; Breast cancer; Chemotherapy; Decision impact; Oncotype DX breast recurrence Score(®); Toxicity.

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