FISH和IHC检测乳腺癌患者HER2/neu基因影响因素的研究

Research on effecting factor of the detection of HER2/neu gene expression in patients with breast cancer by fluorescence in-situ hybridization and by immunohistochemistry

目的观察乳腺癌石蜡包埋组织荧光原位杂交(FISH)和免疫组化(IHC)检测乳腺癌患者HER2/neu基因状态,比较不同切片方法及不同结果判读人员的经验区别。方法 55例乳腺癌石蜡包埋组织分组切片和观察判读,观察1组:由技术人员选定区域切片,平行检测HER2/neu基因状态;观察2组:先切片做HE染色,由初级病理医师根据病理图像选定区域后切片,平行检测HER2/neu基因状态,并由初级病理医师分析结果;观察3组,由中、高级病理医师根据病理图像选定区域后重新切片检测,判读分析。结果观察1组和观察2组,IHC(-)和IHC(1+)与FISH检测一致性较好,IHC(2+)和IHC(3+)与FISH检测的相符率分别为33.33%/33.33%,50.00%/100.00%;2组的一致性分别为中等和较好(K1=0.478,K2=0.659);共有10例患者入选观察3组,重新切片后,6例患者结果不同,其中3例为取材误差,3例为判读误差,3例取材误差均出现在观察1组。结论 FISH和IHC检测乳腺癌患者HER2/neu基因状态受到制片、结果判读等多种因素影响,实验室应制定标准化的操作程序,严密的质量控制和质量保证措施,才可得到准确而可靠的结果。

Objective To compare the influence of different sampling methods and observers on the detection of HER2/neu gene expression in paraffin-embedded tissue of breast cancer by fluorescence in situ hybridization （FISH） and immunohistochemistry （IHC）. Methods 55 cases of paraffin embedded tissues of breast cancer were grouped according to section and observation. In Ob- served Group 1, target section regions were selected and parallel observed by technical staff. In Observed-Group 2, the tissue were first sliced and dyed with HE, the regions for section were selected by ordinary pathologists according to the pathological images, the HER2/neu gene was detected meanwhile and then the results were judged by the same ordinary pathologists. In Observed- Group 3, the regions for section were selected according to the pathological images and the tissues were sliced again and judged by professional pathologists. Results In Observed Group 1 and Observed-Group 2, there was fine consistency between IHC（ ）, IHC （--） and FISH, and the coincidence was 33.33 %/33.33% and 50.00 %/100.00% between IHC（2 ＋ ）, IHC（3-7 ） and FISH. The consistency of Observed Group 1 and 2 were moderate and preferable（K1 = 0. 478,K2 = 0. 659）. 10 cases were grouped into the Ob served-Group 3, among which, after section again, 6 cases were obtained with different results, including 3 cases of sampling error from Observed Group 1, and 3 cases of error judgment. Conclusion Detection of HER2/neu gene in breast cancer by FISH and IHC was influenced by many factors, such as slice preparation and result interpretation. Standardized operating procedures and measures for quality control and assurance should be developed to obtain accurate and reliable results.