Pinder S E, Campbell A F, Bartlett J M S, Marshall A, Allen D, Falzon M, Dunn J A, Makris A, Hughes-Davies L, Stein R C
Division of Cancer Studies, King's College London, Guy's Hospital, Great Maze Pond, London SE1 9RT, UK.
Warwick Clinical Trials Unit, University of Warwick, Gibbet Hill Campus, Coventry CV4 7AL, UK.
Br J Cancer. 2017 Mar 28;116(7):859-863. doi: 10.1038/bjc.2017.28. Epub 2017 Feb 21.
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.
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.
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.
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.
关于在当地医院实验室被归类为雌激素受体（ER）阳性且人表皮生长因子受体同源物2（HER2）阴性的浸润性乳腺癌患者样本进行中心复检的结果，相关数据有限。
早期乳腺癌多参数分析优化个性化治疗初步研究（OPTIMA prelim）是一项随机对照试验的可行性阶段，旨在验证在英国国家医疗服务体系（NHS）中使用多参数检测指导化疗决策的情况。纳入标准包括ER阳性和HER2阴性。受体状态的中心复检是强制性的。
在431例接受中心检测的患者中，仅19例（4.4%；95%置信区间2.5 - 6.3%）患者（共21个肿瘤）的中心实验室结果与当地实验室结果存在差异。经中心复查，7例患者的癌症为ER阴性（1.6%），13例（3.0%）患者的15个肿瘤为HER2阳性疾病，其中1个肿瘤两种生物标志物均存在差异。
在英国NHS环境下对浸润性乳腺癌受体状态进行中心复检显示，在将肿瘤归类为ER阳性和HER2阴性方面具有高度的可重复性，并引发了关于在此环境下该亚组乳腺癌中心复检的成本效益和临床价值的问题。
