A UK prospective multicentre decision impact, decision conflict and economic evaluation of the 21-gene assay in women with node+ve, hormone receptor+ve, HER2-ve breast cancer

Simon Holt ¹, Mark Verrill ², Laura Pettit ³

⁰Swansea University, Swansea, UK. simon_holt@mac.com.

British Journal of Cancer +

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February 2, 2024

View abstract on PubMed

Summary

The Oncotype DX Breast Recurrence Score assay significantly reduced chemotherapy use by 51.5% in early breast cancer patients. This genomic test improved clinical decisions, boosted confidence, and saved the NHS money.

Area Of Science

Oncology
Genomics
Clinical Trials

Background

Evaluating the clinical utility of tumor profiling tests is crucial for demonstrating value in healthcare.
This study assessed the Oncotype DX Breast Recurrence Score (RS) assay in 680 women with HR+, HER2-negative early breast cancer and 1-3 positive lymph nodes within the UK National Health Service (NHS).

Purpose Of The Study

To evaluate the Oncotype DX Breast Recurrence Score assay's impact on clinical decision-making, physician and patient confidence, and economic benefit in early breast cancer management.
To determine if the assay meets established criteria for clinical value.

Main Methods

Physicians and patients documented their chemotherapy preferences and confidence levels (1-5 scale) before receiving the RS result.
Final chemotherapy decisions and post-test confidence levels were recorded after RS result disclosure.

Main Results

The RS result led to a 51.5% reduction in chemotherapy use (95% CI, 47.2-55.8%).
Significant increases in relative and absolute confidence were observed for both physicians and patients.
The assay resulted in an estimated NHS saving of £787 per patient.

Conclusions

The Oncotype DX assay effectively changes clinical decisions in early breast cancer.
The assay demonstrably improves both physician and patient confidence in treatment choices.
The Oncotype DX assay provides economic benefits by reducing healthcare costs within the NHS.