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

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2024年2月2日

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Simon Holt,
Mark Verrill,
Laura Pettit,
Anna Rigg,
Tamas Hickish,
Caroline Archer,
Jo Dent,
Marianne Dillon,
Mark Nathan,
Ludger Barthelmes,
Shazza Rehman,
Yousef Sharaiha,
Paige Innis,
Priya Sai-Giridhar,
Saira Khawaja

摘要

Background

For a tumour profiling test to be of value, it needs to demonstrate that it is changing clinical decisions, improving clinical confidence, and of economic benefit. This trial evaluated the use of the Oncotype DX Breast Recurrence Score® assay against these criteria in 680 women with hormone receptor-positive (HR+), HER2-negative early breast cancer with 1–3 lymph nodes positive (LN+) in the UK National Health Service (NHS).

Methods

Prior to receipt of the Recurrence Score (RS) result, both the physician and the patient were asked to state their preference for or against chemotherapy and their level of confidence on a scale of 1–5. Following receipt of the RS result, the physician and patient were asked to make a final decision regarding chemotherapy and record their post-test level of confidence.

Results

Receipt of the RS result led to a 51.5% (95% CI, 47.2–55.8%) reduction in chemotherapy, significantly increased the relative and absolute confidence for both physicians and patients and led to an estimated saving to the NHS of £787 per patient.

Conclusion

The use of the Oncotype DX assay fulfils the criteria of changing clinical decisions, improving confidence and saving money.