Irish national real-world analysis of the clinical and economic impact of 21-gene oncotype DX® testing in early-stage, 1-3 lymph node-positive, oestrogen receptor-positive, HER2-negative, breast cancer

Breast Cancer Res Treat. 2025 Jan;209(1):189-199. doi: 10.1007/s10549-024-07486-5. Epub 2024 Oct 4.

Abstract

Purpose: The treatment landscape of Oestrogen receptor-positive (ER-positive) breast cancer is evolving, with declining chemotherapy use as a result of Oncotype DX Breast Recurrence Score® testing. Results from the SWOG S1007 RxPONDER trial suggest that adjuvant chemotherapy may benefit some premenopausal women with ER-positive, HER2-negative disease with 1-3 positive lymph nodes (N1), and a Recurrence Score® (RS) of ≤ 25. Postmenopausal women with similar characteristics did not benefit from adjuvant chemotherapy. We examine the clinical and economic impact of Oncotype DX® testing on treatment decisions in patients with N1 disease in Ireland using real world data.

Methods: From March 2011 to October 2022, a retrospective, cross-sectional observational study was performed of patients with ER-positive, HER2-negative N1 breast cancer, who had Oncotype DX testing across 5 of Ireland's largest cancer centres. Patients were classified into low risk (RS 0-13), intermediate risk (RS 14-25) and high risk (RS > 25). Data were collected via electronic patient records. Information regarding costing was provided primarily by pre-published sources.

Results: A total of 828 N1 patients were included in this study. Post Oncotype DX testing, 480 patients (58%) were spared chemotherapy. Of the patients who had a change in chemotherapy recommendation based on Oncotype DX testing, 271 (56%), 205 (43%), 4 (1%) had a RS result of 0-13, 14-25 and > 25 respectively. Use of Oncotype DX testing was associated with a 58% reduction in chemotherapy administration overall. This resulted in estimated savings of over €6 million in treatment costs. Deducting the assay cost, estimated net savings of over €3.3 million were achieved. Changes in the ordering demographics of Oncotype DX tests were identified after RxPONDER data were presented, with increased testing in women ≥ 50 years and a reduction in proportion of tests ordered for women < 50 years.

Conclusion: Between 2011 and 2022, assay use resulted in a 58% reduction in chemotherapy administration and net savings of over €3.3 million.

Keywords: Breast cancer; Decision impact; Economic impact; Node-positive; Oncotype DX recurrence score.

Publication types

  • Multicenter Study
  • Observational Study

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Biomarkers, Tumor* / genetics
  • Breast Neoplasms* / drug therapy
  • Breast Neoplasms* / economics
  • Breast Neoplasms* / genetics
  • Breast Neoplasms* / pathology
  • Breast Neoplasms* / therapy
  • Chemotherapy, Adjuvant / economics
  • Cost-Benefit Analysis
  • Cross-Sectional Studies
  • Erb-b2 Receptor Tyrosine Kinases / metabolism
  • Female
  • Gene Expression Profiling / economics
  • Gene Expression Profiling / methods
  • Humans
  • Ireland / epidemiology
  • Lymph Nodes / pathology
  • Lymphatic Metastasis
  • Middle Aged
  • Neoplasm Recurrence, Local / genetics
  • Neoplasm Staging
  • Receptors, Estrogen / metabolism
  • Retrospective Studies

Substances

  • Biomarkers, Tumor
  • Erb-b2 Receptor Tyrosine Kinases
  • Receptors, Estrogen
  • ERBB2 protein, human