| Object:Comparing the results of the interpretation of the 2019 and 2014 breast cancer HER2 detection guidelines,we analyzed the impact of the updated guidelines on the amplification status and protein expression status of the human epidermal growth factor receptor 2(HER2)gene in breast cancer and its clinical significance.To explore the difference in pathological characteristics between HER2-positive and HER2-negative breast cancer.Methods:1.The 3102 patients with invasive breast cancer in the Department of Pathology of Qingdao University Affiliated Hospital from 2016 to 2018 were collected and performed immunohistochemistry(IHC)detection and fluorescence in situ hybridization(FISH)detection.2.The IHC and FISH slices of HER2 were interpreted according to the interpretation standards of version 2014 and version 2019 respectively,and the results were recorded and sorted out.3.According to the FISH detection standard of the 2019 edition guidelines,the cases were divided into HER2 positive group and HER2 negative group.The histological grade,tumor size,vascular tumor thrombus and other pathological features of the two groups were sorted and analyzed.4.Perform a chi-square test on the obtained data and discuss the results.Results:1.In the IHC results interpreted according to the 2014 version of the HER2 standard,the numbers of positive,uncertain and negative cases were 20.02%(621/3102),12.99%(403/3102),66.99%(2078/3102).In the IHC results interpreted according to the2019 version of the HER2 standard,the number of positive,uncertain,and negative cases were 20.02%(621/3102),12.80%(397/3102),and 67.18%(2084/3102).There was no statistically significant difference between the two(P>0.05).2.In the FISH results interpreted according to the 2014 version of the HER2 test standard,the numbers of positive,uncertain,and negative cases were 24.11%(748/3102),3.00%(93/3102),72.89%(2261/3102).According to the 2019 version of the HER2 standard,the number of positive,uncertain,and negative FISH results were 23.11%(717/3102),0(0/3102),76.89%(2385/3102).The changes in the results produced by the 2019 version of the standard are statistically significant(P<0.05).3.Among the HER2 positive cases,the number of histological grades of grade I,grade II,and grade III were 0(0/717),38.35%(275/717),and 61.65%(442/717).In HER2 negative cases,the number of histological grades grade I,grade II,and grade III were 4.78%(114/2385),68.68%(1638/2385),and 26.54%(633/2385).There was significant difference in histological grade between HER2 positive breast cancer and HER2 negative breast cancer(P<0.05).The number of tumors in T1,T2,T3,and T4 stages were 46.86%(336/717),51.05%(366/717),2.09%(15/717),0(0/717)in HER2 positive cases,while the number of cases of T1,T2,T3,and T4 stages in HER2 negative cases were 63.90%(1524/2385),35.22%(840/2385),0.88%(21/2385),0(0/2385),HER2 positive breast cancer and HER2 negative breast cancer have a significant difference in tumor T staging(P<0.05).25.10%(180/717)of HER2 positive cases were positive for vascular tumor thrombi,and 22.35%(533/2385)of HER2 negative cases were positive for vascular tumor thrombi.There was no statistically significant difference between the two(P>0.05).The number of positive cases of estrogen receptor(ER)and progesterone receptor(PR)were 53.14%(381/717)and43.24%(310/717)in HER2 positive cases.The number of positive cases of ER and PR were86.12%(2054/2385)and 81.97%(1955/2385)in the HER2 negative cases.There was a significant difference in the ER and PR positive rates between HER2 positive and HER2 negative cases(P<0.05).In the HER2 positive cases,95.26%(683/717)had high expression of Ki-67 and 4.74%(34/717)had low expression,while in the HER2 negative cases,72.33%(1725/2385)had high expression of Ki-67 and 27.67%(660/2385)had low expression.The high expression rate of Ki-67 in HER2 negative cases was significantly lower than that in HER2 positive cases(P < 0.05).4.The numbers of young,middle-aged,and old were 2.65%(19/717),39.61%(284/717),and 57.74%(414/717)in HER2 positive cases.The numbers of young,middle-aged,and old were 3.56%(85/2385),44.82%(1069/2385),51.62%(1231/2385)in HER2 negative cases.The age of HER2 positive patients was slightly higher than that of HER2 negative patients,and the difference was statistically significant(P<0.05).53.70%(385/717)of HER2 positive patients had the disease on the left side,46.30%(332/717)had the disease on the right side,50.06%(1194/2385)of the HER2 negative patients had the disease on the left side,and49.94%(1191/2385)on the right side.There was no significant difference in the laterality of patients with HER2 positive and HER2 negative patients(P>0.05).Conclusion:Compared with HER2 negative breast cancer,HER2 positive breast cancer has the following characteristics: high histological grade,high expression of Ki-67,high tumor T stage,low ER and PR expression rate.The age distribution of HER2 positive breast cancer is significantly different from that of HER2 negative breast cancer,and there is no significant difference in the diseased side and vascular tumor thrombus.After the application of the 2019 version of the guidelines,the negative rate of HER2 detection of breast cancer increased,the positive rate and the number of uncertain cases decreased to a certain extent,and the interpretation results were more clear,which was more conducive to the choice of clinical treatment. |