Aznab Mozafar, Izadi Babak, Amirian Farhad, Khazaei Sedigheh, Madani Seyed Hamid, Ramezani Mazaher
Department of Internal Medicine, Imam Reza Hospital, Kermanshah University of Medical Sciences, Kermanshah, Iran.
Molecular Pathology Research Center, Imam Reza Hospital, Kermanshah University of Medical Sciences, Kermanshah, Iran.
Int J Hematol Oncol Stem Cell Res. 2022 Oct 1;16(4):217-223. doi: 10.18502/ijhoscr.v16i4.10879.
: Amplification of HER2 is an important factor in the diagnosis and treatment of breast cancer. Fluorescence in situ hybridization (FISH) is the gold standard for the detection of HER2-positive tumors. However, the Immunohistochemistry (IHC) assay for the detection of HER2 is more popular in the preclinical laboratory since it is faster and more economical compared to the FISH test. : In this study, the status of HER2 amplification is determined by the FISH test using 44 formalin-fixed paraffin-embedded tissue samples and comparing the results with the IHC test to determine the reliability of the IHC test. Also, the relationship between HER2 amplification and estrogen, progesterone receptors, P53, age, menopausal status, family history of breast cancer, tumor size, and histological grade were determined. : Examination of HER2 in 44 samples by IHC showed 3 (6.8%) and 5 (11.4%) samples were positive (IHC 3+) and negative (IHC 0, 1+), respectively, and 36 (81.8%) samples were ambiguous (IHC 2 +), but examination by FISH showed 21 samples (47, 7%) were positive and 23 samples (52, 3%) were negative. There was a significant difference between IHC and FISH in the detection of HER2 amplification (P=0.019). Also, there was a significant difference between HER2 amplification and menopause in patients (P=0.035). : This result demonstrated that the IHC test is not a reliable test to determine HER2 amplification. This study represented that FISH analysis is more reliable than IHC and must be preferentially performed for all cases, especially for HER2 +2 cases for whom the IHC result is 2+.
HER2基因扩增是乳腺癌诊断和治疗的重要因素。荧光原位杂交（FISH）是检测HER2阳性肿瘤的金标准。然而，检测HER2的免疫组织化学（IHC）检测在临床前实验室中更受欢迎，因为与FISH检测相比，它更快且更经济。
在本研究中，使用44个福尔马林固定石蜡包埋组织样本通过FISH检测确定HER2扩增状态，并将结果与IHC检测进行比较，以确定IHC检测的可靠性。此外，还确定了HER2扩增与雌激素、孕激素受体、P53、年龄、绝经状态、乳腺癌家族史、肿瘤大小和组织学分级之间的关系。
通过IHC对44个样本进行HER2检测，结果显示分别有3个（6.8%）和5个（11.4%）样本为阳性（IHC 3+）和阴性（IHC 0、1+），36个（81.8%）样本结果不明确（IHC 2+），但通过FISH检测显示21个样本（47.7%）为阳性，23个样本（52.3%）为阴性。IHC和FISH在检测HER2扩增方面存在显著差异（P=0.019）。此外，患者的HER2扩增与绝经之间也存在显著差异（P=0.035）。
该结果表明，IHC检测不是确定HER2扩增的可靠检测方法。本研究表明，FISH分析比IHC更可靠，对于所有病例都必须优先进行，特别是对于IHC结果为2+的HER2 +2病例。
