Rezvani Hamid, Forghani Shayan, Forghani Arman, Sabet Fatemeh Mahdavi, Akbari Atieh, Tabarestani Sanaz
Department of Hematology-Oncology Shahid Beheshti University of Medical Sciences Tehran Iran.
Cancer Research Center Shahid Beheshti University of Medical Sciences Tehran Iran.
Health Sci Rep. 2025 Jul 15;8(7):e71062. doi: 10.1002/hsr2.71062. eCollection 2025 Jul.
Hormone receptors are expressed in 70% of breast cancers and are the major biomarkers for tailoring treatment in early-stage breast cancer. In clinical routine, immunohistochemistry (IHC) is used to assess estrogen receptor (ER), progesterone receptor (PR), HER2, and Ki67 protein expression. However, IHC procedure is challenged with pre-analytical and analytical variability. Pathologist interpretation of IHC results can vary, and discordant results between local and reference laboratories have been reported. Using mRNA-based tests may be a more robust, reliable, and standardized method to assess these important breast cancer biomarkers. This study aimed to assess the concordance between real-time PCR and IHC results.
In this study, we analyzed 178 early-stage hormone receptor-positive breast tumors. IHC for ER, PR, HER2, and Ki67 had been previously performed for the study samples at local laboratories. For samples with HER2 IHC score 2+, Fluorescence In Situ Hybridization was performed. (encoding ER), (encoding PR), (encoding HER2), and (encoding Ki67) mRNA expression were determined using TaqMan gene expression assays.
The overall concordance between mRNA expression results and their corresponding IHC markers was 95.9% for /ER, 79.3% for /PR, and 100% for /HER2. There was a moderate correlation between MKi67 mRNA values and Ki67 IHC. ESR1 expression was significantly lower in tumors of younger patients ( < 0.001). No statistically significant correlation between age at cancer diagnosis and ER IHC was identified. Higher and mRNA expression was associated with worse pathological characteristics.
PCR-based classification of breast tumors in a central laboratory may be used to confirm the available IHC results performed at local laboratories and add valuable information for patient management. mRNA-based biomarkers may be promising for more standardized breast cancer management.
70%的乳腺癌中表达激素受体,其是早期乳腺癌治疗方案制定的主要生物标志物。在临床常规工作中,免疫组织化学(IHC)用于评估雌激素受体(ER)、孕激素受体(PR)、人表皮生长因子受体2(HER2)和Ki67蛋白表达。然而,免疫组化程序面临分析前和分析变异性的挑战。病理学家对免疫组化结果的解读可能存在差异,并且已有报道称本地实验室与参考实验室之间的结果不一致。使用基于mRNA的检测方法可能是评估这些重要乳腺癌生物标志物的更稳健、可靠和标准化的方法。本研究旨在评估实时聚合酶链反应(PCR)与免疫组化结果之间的一致性。
在本研究中,我们分析了178例早期激素受体阳性乳腺肿瘤。此前已在本地实验室对研究样本进行了ER、PR、HER2和Ki67的免疫组化检测。对于HER2免疫组化评分为2+的样本,进行了荧光原位杂交检测。使用TaqMan基因表达分析方法测定了(编码ER)、(编码PR)、(编码HER2)和(编码Ki67)的mRNA表达。
mRNA表达结果与其相应免疫组化标志物之间的总体一致性,/ER为95.9%,/PR为79.3%,/HER2为100%。MKi67 mRNA值与Ki67免疫组化之间存在中度相关性。ESR1表达在年轻患者的肿瘤中显著较低(<0.001)。未发现癌症诊断年龄与ER免疫组化之间存在统计学显著相关性。较高的和mRNA表达与较差的病理特征相关。
中心实验室基于PCR的乳腺肿瘤分类可用于确认本地实验室获得的免疫组化结果,并为患者管理提供有价值的信息。基于mRNA的生物标志物对于更标准化地管理乳腺癌可能具有前景。