Oncotype Dx node positive study
Research type
Research Study
Full title
The Impact of the Oncotype DX® Breast Cancer Assay on Treatment Decisions in a UK Population of Patients with Estrogen Receptor-Positive Early Breast Cancer with 1-3 Positive Lymph Nodes, who are Potential Candidates for Chemotherapy, but for whom the Benefits of Chemotherapy are Uncertain
IRAS ID
219163
Contact name
Saira Khawaja
Contact email
Sponsor organisation
Hywel Dda University Health Board
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Research Summary
The main goal of this study is to show how the results of the Oncotype DX® test changes the decisions of physicians in the UK for women with ER-positive (ER+), early breast cancer (EBC) with 1-3 positive lymph nodes who are potential candidates for chemotherapy, but for whom the benefits of chemotherapy may be uncertain. This study will also assess how the results of the Oncotype DX assay affect the treatment preferences of the patient.
Summary of Results
Introduction:
For a medical test to be of value, it needs to show that it is changing treatment decisions, improving confidence in the chosen treatments (for both doctors and patients), and, if possible, also to save money.This trial looked at the use of the Oncotype DX Breast Recurrence Score test in 680 women with breast cancer who had hormone sensitive early breast cancer with 1 to 3 affected lymph glands found in the under-arm area. All patients were treated by the NHS in a range of different hospitals.
How the research was done:
Prior to knowing the result of the Recurrence Score (RS), both doctor and patient were asked to decide if chemotherapy should be used and to score their level of confidence with their decision. Following receipt of the test result, the physician and patient were then asked to make a final decision about the use of chemotherapy or not and again to record their level of confidence in this second decision.Results:
Following getting the result of the test, more than half of the patients who initially intended to get chemotherapy were found to be able to safely avoid this treatment. With the test result confidence in the recommended treatment for both the doctors and patients was significantly increased even if the decision was changed. By using the test there was an estimated saving to the NHS of about £800 per patient.Conclusion:
Use of the Oncotype DX test leads to many patients safely avoiding the unpleasant effects of chemotherapy, improves their confidence that they are getting the right treatment and saves the NHS money.Benefits of this research:
This evidence from this research now means that this test is available to all patient with this type of breast cancer and that it will automatically be paid for by the NHS.REC name
Wales REC 7
REC reference
17/WA/0227
Date of REC Opinion
22 Aug 2017
REC opinion
Further Information Favourable Opinion