雌激素受体（ER）、孕激素受体（PgR）和人表皮生长因子受体2（HER2）的蛋白质（通过免疫组化法）、基因（通过荧光原位杂交法；仅针对HER2）以及微阵列读数（通过TargetPrint）的高度一致性：欧洲癌症研究与治疗组织10041/国际乳腺癌研究组03-04 MINDACT试验的结果
High concordance of protein (by IHC), gene (by FISH; HER2 only), and microarray readout (by TargetPrint) of ER, PgR, and HER2: results from the EORTC 10041/BIG 03-04 MINDACT trial.
作者信息
Viale G, Slaets L, Bogaerts J, Rutgers E, Van't Veer L, Piccart-Gebhart M J, de Snoo F A, Stork-Sloots L, Russo L, Dell'Orto P, van den Akker J, Glas A, Cardoso F
机构信息
Department of Pathology, European Institute of Oncology and University of Milan, Milan, Italy.
Department of Statistics, European Organization for Research and Treatment of Cancer, Brussels, Belgium.
出版信息
Ann Oncol. 2014 Apr;25(4):816-823. doi: 10.1093/annonc/mdu026.
BACKGROUND
To investigate the correlation of TargetPrint with local and central immunohistochemistry/fluorescence in situ hybridization assessment of estrogen (ER), progesterone (PgR), and human epidermal growth factor receptor 2 (HER2) in the first 800 patients enrolled in the MINDACT trial.
PATIENTS AND METHODS
Data from local (N = 800) and central (N = 626) assessments of receptor status were collected and compared with TargetPrint results.
RESULTS
For ER, the positive agreement (the percentage of central pathology positive assessments that were also TargetPrint/local laboratory positive) for TargetPrint in comparison to centralized assessment was 98% with a negative agreement (the percentage of central pathology negative assessments that were also TargetPrint/local laboratory negative) of 96%. For PgR, the positive agreement was 83% with a negative agreement of 92%. For HER2, the positive agreement was 75% with a negative agreement of 99%. Even though the local assessment showed higher positive agreement for PgR (89%) and higher positive agreement for HER2 (85%), the range of discordant local versus central assessments were as high as 6.7% for ER, 12.9% for PgR, and 4.3% for HER2.
CONCLUSION
TargetPrint and local assessment of ER, PgR, and HER2 show high concordance with central assessment in the first 800 MINDACT patients. However, there are concerns about the higher discordance rates for some local sites. TargetPrint can improve the reliability of hormone receptor and HER2 testing for those centers with a lower rate of concordance with the reference laboratory, with the limitation of a positive agreement of 75% for HER2. TargetPrint consequently has important implications for treatment decisions in clinical practice and is a reliable alternative to local assessment for ER.
CLINICAL TRIALS NUMBER
NCT00433589.
背景
在纳入MINDACT试验的前800例患者中，研究TargetPrint与雌激素（ER）、孕激素（PgR）和人表皮生长因子受体2（HER2）的局部及中心免疫组织化学/荧光原位杂交评估之间的相关性。
患者与方法
收集受体状态的局部（N = 800）和中心（N = 626）评估数据，并与TargetPrint结果进行比较。
结果
对于ER，与中心评估相比，TargetPrint的阳性一致性（中心病理阳性评估中同时也是TargetPrint/当地实验室阳性的百分比）为98%，阴性一致性（中心病理阴性评估中同时也是TargetPrint/当地实验室阴性的百分比）为96%。对于PgR，阳性一致性为83%，阴性一致性为92%。对于HER2，阳性一致性为75%，阴性一致性为99%。尽管局部评估显示PgR的阳性一致性更高（89%），HER2的阳性一致性更高（85%），但ER的局部与中心评估不一致范围高达6.7%，PgR为12.9%，HER2为4.3%。
结论
在MINDACT试验的前800例患者中，TargetPrint以及ER、PgR和HER2的局部评估与中心评估高度一致。然而，一些局部检测点的不一致率较高令人担忧。对于那些与参考实验室一致性较低的中心，TargetPrint可提高激素受体和HER2检测的可靠性，但HER2的阳性一致性为75%存在局限性。因此，TargetPrint对临床实践中的治疗决策具有重要意义，并且是ER局部评估的可靠替代方法。
临床试验编号
NCT00433589。
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