Papadopoulos Savvas, Kouvatseas George, Skarlos Dimosthenis, Malamos Nikolaos, Delliou Eleftheria, Saratsiotou Ioanna, Ardavanis Alexandros, Mavroudis Dimitrios, Skarpidi Evangelia, Arapantoni Petroula, Karyda Irini, Patakioyta Frideriki, Aravantinos Gerasimos, Razis Evangelia, Fountzilas George, Kosmidis Paris
Department of Pathology, Hygeia Hospital-Harvard Medical International, Maroussi, Athens, Greece.
Clin Breast Cancer. 2007 Oct;7(10):784-90. doi: 10.3816/CBC.2007.n.040.
HER2 gene amplification and overexpression is associated with aggressive breast cancer and poor prognosis. Accurate HER2 testing of patients with breast cancer before treatment is important to ensure that as many patients with HER2-positive breast cancer as possible receive the most appropriate treatment and that women with HER2-negative disease avoid a potentially toxic therapy. This study compares immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) HER2 testing at central and regional laboratories in Greece.
The HER2 status of 458 breast cancer samples was determined by IHC in central and regional laboratories using commercially available anti-HER2 antibodies. FISH analysis, scored as number of signals or a ratio, was subsequently performed by the central laboratory on most samples. Various statistical analyses were used to examine concordance between test center results.
Immunohistochemistry HER2 testing was successfully performed on 445 samples in the central laboratory and 381 samples in regional laboratories, with good concordance between central and regional laboratories. After FISH analyses of a large proportion of these samples, good correlation was observed between FISH HER2 status and IHC results from the central laboratory but not from regional laboratories. These data suggest that HER2 status determined by IHC in a central laboratory is generally more accurate than that determined by a regional laboratory.
This study emphasizes the importance of accurate HER2 testing and the need to continually check the reproducibility and reliability of the test.
HER2基因扩增和过表达与侵袭性乳腺癌及不良预后相关。在治疗前对乳腺癌患者进行准确的HER2检测，对于确保尽可能多的HER2阳性乳腺癌患者接受最合适的治疗，以及使HER2阴性疾病的女性避免潜在的毒性治疗非常重要。本研究比较了希腊中央实验室和区域实验室进行的免疫组织化学（IHC）和荧光原位杂交（FISH）HER2检测。
458例乳腺癌样本的HER2状态在中央实验室和区域实验室通过使用市售抗HER2抗体的免疫组织化学方法进行测定。中央实验室随后对大多数样本进行了FISH分析，并将结果计为信号数量或比例。采用多种统计分析方法来检验检测中心结果之间的一致性。
中央实验室对445例样本成功进行了免疫组织化学HER2检测，区域实验室对381例样本进行了检测，中央实验室和区域实验室之间具有良好的一致性。在对这些样本中的大部分进行FISH分析后，观察到FISH HER2状态与中央实验室而非区域实验室的免疫组织化学结果之间具有良好的相关性。这些数据表明，中央实验室通过免疫组织化学测定的HER2状态通常比区域实验室测定的更准确。
本研究强调了准确的HER2检测的重要性以及持续检查检测的可重复性和可靠性的必要性。
