Discrepancies in central review re-testing of patients with ER-positive and HER2-negative breast cancer in the OPTIMA prelim randomised clinical trial

Autor: Pinder, S. E., Campbell, Amy, Bartlett, J. M. S., Marshall, A. (Andrea)‏, Allen, D., Falzon, M., Dunn, Janet A., Makris, A., Hughes-Davies, L., Stein, R. C., HASH(0x5651c9d1a1b8)
Jazyk: angličtina
Rok vydání: 2017
Předmět:
0301 basic medicine
Oncology
Cancer Research
Cost effectiveness
Receptor
ErbB-2
Estrogen receptor
law.invention
Immunoenzyme Techniques
0302 clinical medicine
Randomized controlled trial
law
Antineoplastic Combined Chemotherapy Protocols
Medicine
Prognosis
oestrogen receptor
Receptors
Estrogen
Chemotherapy
Adjuvant
Research Design
030220 oncology & carcinogenesis
Female
medicine.drug
Adult
medicine.medical_specialty
Concordance
Breast Neoplasms
RC0254
03 medical and health sciences
Breast cancer
breast cancer
Internal medicine
HER2
Biomarkers
Tumor
Medical Laboratory Science
Humans
Neoplasm Invasiveness
Neoplasm Staging
business.industry
Reproducibility of Results
medicine.disease
Decision Support Systems
Clinical
Confidence interval
Surgery
Clinical trial
030104 developmental biology
Clinical Study
Feasibility Studies
business
Tamoxifen
Follow-Up Studies
Zdroj: British Journal of Cancer
Pinder, S, Campbell, A F, Bartlett, J M S, Marshall, A, Allen, D, Falzon, M, Dunn, J A, Makris, A, Hughes-Davies, L & 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, vol. 116, no. 7, pp. 859-863 . https://doi.org/10.1038/bjc.2017.28
ISSN: 0007-0920
Popis: Background:\ud 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.\ud \ud Methods:\ud 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.\ud \ud Results:\ud 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.\ud \ud Conclusions:\ud 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.
Databáze: OpenAIRE
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