The impact of Oncotype DX breast cancer assay results on clinical practice: a UK experience

Breast Cancer Res Treat. 2020 Apr;180(3):809-817. doi: 10.1007/s10549-020-05578-6. Epub 2020 Mar 13.

Abstract

Background: Genomic tests are increasingly being used by clinicians when considering adjuvant chemotherapy for patients with oestrogen receptor-positive (ER+), human epidermal growth factor 2-negative (HER2-) breast cancer. The Oncotype DX breast recurrence score assay was the first test available in the UK National Health Service. This study looked at how UK clinicians were interpreting Recurrence Scores (RS) in everyday practice.

Methods: RS, patient and tumour characteristics and adjuvant therapy details were retrospectively collected for 713 patients from 14 UK cancer centres. Risk by RS-pathology-clinical (RSPC) was calculated and compared to the low/intermediate/risk categories, both as originally defined (RS < 18, 18-30 and > 30) and also using redefined boundaries (RS < 11, 11-25 and > 25).

Results: 49.8%, 36.2% and 14% of patients were at low (RS < 18), intermediate (RS 18-30) and high (RS > 30) risk of recurrence, respectively. Overall 26.7% received adjuvant chemotherapy. 49.2% of those were RS > 30; 93.3% of patients were RS > 25. Concordance between RS and RSPC improved when intermediate risk was defined as RS 11-25.

Conclusions: This real-world data demonstrate the value of genomic tests in reducing the use of adjuvant chemotherapy in breast cancer. Incorporating clinical characteristics or RSPC scores gives additional prognostic information which may also aid clinicians' decision making.

Keywords: Adjuvant chemotherapy; Biomarkers; Breast cancer; Early breast cancer; Oncotype DX breast recurrence score assay.

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Biomarkers, Tumor / genetics*
  • Breast Neoplasms / drug therapy*
  • Breast Neoplasms / genetics
  • Breast Neoplasms / pathology
  • Chemotherapy, Adjuvant
  • Clinical Decision-Making*
  • Female
  • Follow-Up Studies
  • Gene Expression Profiling
  • Humans
  • Middle Aged
  • Neoplasm Recurrence, Local / drug therapy*
  • Neoplasm Recurrence, Local / genetics
  • Neoplasm Recurrence, Local / pathology
  • Practice Guidelines as Topic / standards*
  • Prognosis
  • Receptor, ErbB-2 / metabolism
  • Receptors, Estrogen / metabolism
  • Receptors, Progesterone / metabolism
  • Research Design*
  • Retrospective Studies
  • United Kingdom

Substances

  • Biomarkers, Tumor
  • Receptors, Estrogen
  • Receptors, Progesterone
  • ERBB2 protein, human
  • Receptor, ErbB-2