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Discrepancies in central review re-testing of patients with ER-positive and HER2-negative breast cancer in the OPTIMA prelim randomised clinical trial
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OPTIMA Trial Management Group (Including: Pinder, S. E., Campbell, Amy, Bartlett, J. M. S., Marshall, A. (Andrea), Allen, D., Falzon, M., Dunn, Janet A., Makris, A., Hughes-Davies, L. and Stein, R. C.). (2017) Discrepancies in central review re-testing of patients with ER-positive and HER2-negative breast cancer in the OPTIMA prelim randomised clinical trial. British Journal of Cancer, 116 . 859-863 . doi:10.1038/bjc.2017.28 ISSN 0007-0920.
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Official URL: http://doi.org/10.1038/bjc.2017.28
Abstract
Background:
There is limited data on results of central re-testing of samples from patients with invasive breast cancer categorised in their local hospital laboratories as oestrogen receptor (ER) positive and human epidermal growth factor receptor homologue 2 (HER2) negative.
Methods:
The Optimal Personalised Treatment of early breast cancer usIng Multiparameter Analysis preliminary study (OPTIMA prelim) was the feasibility phase of a randomised controlled trial to validate the use of multiparameter assay-directed chemotherapy decisions in the UK National Health Service (NHS). Eligibility criteria included ER positivity and HER2 negativity. Central re-testing of receptor status was mandatory.
Results:
Of the 431 patients tested centrally, discrepant results between central and local laboratory results were identified in only 19 (4.4%; 95% confidence interval 2.5–6.3%) patients (with 21 tumours). On central review, seven patients had cancers that were ER-negative (1.6%) and 13 (3.0%) patients with 15 tumours had HER2-positive disease, including one tumour discrepant for both biomarkers.
Conclusions:
Central re-testing of receptor status of invasive breast cancers in the UK NHS setting shows a high level of reproducibility in categorising tumours as ER-positive and HER2-negative, and raises questions regarding the cost effectiveness and clinical value of central re-testing in this sub-group of breast cancers in this setting.
Item Type: | Journal Article | ||||||||
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Subjects: | R Medicine > RC Internal medicine > RC0254 Neoplasms. Tumors. Oncology (including Cancer) | ||||||||
Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School | ||||||||
SWORD Depositor: | Library Publications Router | ||||||||
Library of Congress Subject Headings (LCSH): | Breast -- Cancer -- Patients, Breast -- Cancer -- Diagnosis, Clinical trials | ||||||||
Journal or Publication Title: | British Journal of Cancer | ||||||||
Publisher: | Nature Publishing Group | ||||||||
ISSN: | 0007-0920 | ||||||||
Official Date: | 28 March 2017 | ||||||||
Dates: |
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Volume: | 116 | ||||||||
Page Range: | 859-863 | ||||||||
DOI: | 10.1038/bjc.2017.28 | ||||||||
Status: | Peer Reviewed | ||||||||
Publication Status: | Published | ||||||||
Access rights to Published version: | Open Access (Creative Commons) | ||||||||
Date of first compliant deposit: | 15 February 2018 | ||||||||
Date of first compliant Open Access: | 21 February 2018 | ||||||||
RIOXX Funder/Project Grant: |
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