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

I M Browne; R A McLaughlin; C S Weadick; S O'Sullivan; L M McSorley; D K Hadi; S J Millen; M J Higgins; J P Crown; R S Prichard; D P McCartan; A Dk Hill; R M Connolly; S A Noonan; D O'Mahony; C Murray; C O'Hanlon-Brown; B T Hennessy; C M Quinn; C M Kelly; S O'Reilly; P G Morris; J M Walshe

doi:10.1007/s10549-024-07486-5

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. 2024 Oct 4. doi: 10.1007/s10549-024-07486-5. Online ahead of print.

Authors

I M Browne¹, R A McLaughlin², C S Weadick³, S O'Sullivan⁴, L M McSorley⁵, D K Hadi⁶, S J Millen⁷, M J Higgins⁵, J P Crown⁵, R S Prichard⁸, D P McCartan⁸, A Dk Hill⁹, R M Connolly^{10

11}, S A Noonan^{10

11}, D O'Mahony¹², C Murray¹³, C O'Hanlon-Brown⁶, B T Hennessy², C M Quinn¹³, C M Kelly⁴, S O'Reilly^{10

11}, P G Morris², J M Walshe^{5

14

15}

Affiliations

¹ Department of Medical Oncology, St Vincent's University Hospital, Dublin 4, Ireland. ibrowne@tcd.ie.
² Department of Medical Oncology, Beaumont Hospital, Beaumont, Dublin, Ireland.
³ Department of Medical Oncology, Cork University Hospital, Cork, Ireland.
⁴ Department of Medical Oncology, Mater Misericordiae University Hospital, Dublin 7, Ireland.
⁵ Department of Medical Oncology, St Vincent's University Hospital, Dublin 4, Ireland.
⁶ Department of Medical Oncology, St James's Hospital, Dublin 8, Ireland.
⁷ Exact Sciences UK Ltd, London, UK.
⁸ Department of Surgery, St. Vincent's University Hospital, Dublin, Ireland.
⁹ Department of Surgery, Royal College of Surgeons, Dublin, Ireland.
¹⁰ Cancer Research @ UCC, University College Cork, Cork, Ireland.
¹¹ Cork University Hospital/University College Cork Cancer Centre, Cork, Ireland.
¹² Department of Medical Oncology, Bon Secours Hospital, Cork, Ireland.
¹³ Department of Pathology, St. Vincent's University Hospital, Dublin 4, Ireland.
¹⁴ University College Dublin, Dublin, Ireland.
¹⁵ Cancer Trials Ireland, Dublin, Ireland.

PMID: 39365509
DOI: 10.1007/s10549-024-07486-5

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.