Oncotype Dx in early breast Cancer: first UK prospective trial.


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Gianfilippo Bertelli1, Delia Pudney1, Martin Rolles1, Maung Moe1, Elaine Brinkworth1, Sian Whelan2, Sarah Khawaja2, Simon Holt1
1Singleton Hospital, Swansea, United Kingdom,2Prince Philip Hospital, Lanelli, United Kingdom

Background

Patients with node-negative, ER+ early breast cancer often receive adjuvant chemotherapy based on relative indications e.g. histological grade or tumour size, potentially with little benefit over adjuvant hormone therapy alone. Multigene expression analyses, such as the 21-gene assay Oncotype DX  are increasingly used abroad, but not yet in the UK, to assist decision making in this group of patients. The effects of Oncotype DX on the use of adjuvant chemotherapy may be different in different countries, depending on national treatment attitudes and guidelines, with potential consequences for costs of care. We have designed a prospective trial to assess the impact of the test in the setting of the UK’s NHS.

Method

Patients with node negative, ER+ operable breast cancer are eligible for the trial (target n=150). Patients with pN1(mic) nodal status are also eligible: HER2 positivity is not an exclusion criterion. Following informed consent a paraffin-embedded tumour block or unstained slides are submitted after surgery to Genomic Health Inc (Redwood City, CA). Results are available electronically after 7-21 days. The study is not randomized as its primary endpoint is the impact of Oncotype DX on treatment recommendations, assessed through questionnaires filled by patients and their oncologists before and after the test. Secondary endpoints are patients’ satisfaction and pharmacoeconomic effects of changes in treatment recommendations.

Results

Recruitment started in January 2010, 50 patients were enrolled by June. Results of an interim analysis will be presented at the Conference.

Conclusion

Our study, representing the first prospective assessment of Oncotype DX in the UK, will provide data on the impact of the test when used in addition to standard phenotyping to assist decision-making in early breast cancer. This may be of interest for regulatory bodies and for research groups currently planning larger studies of gene profiling in the UK