| Objective: Compare the differences between the 2013 and 2018 ASCO/CAP(American Society of Clinical Oncology/American College of Pathologists)HER-2 testing guidelines to explore the clinical utility of the 2018 guideline in prognostic analysis.Methods:1.Screening of the medical records from October 2014 to October 2017 for histopathological diagnosis of invasive breast cancer(IBC)and whose immunohistochemistry were performed as Human Epidermal Growth Factor Receptor 2(HER-2)2+ and underwent Fluorescence in situ hybridization(FISH),a total of 1419 cases.Collect their clinical pathological data and follow up.2.According to the 2013 and 2018 ASCO/CAP HER-2 testing guidelines,after excluding the use of anti-HER-2 targeted therapy,the prognosis of patients with altered outcomes and unchanged outcomes were analyzed and compared to determine whether the 2018 ASCO/CAP HER-2 testing guideline is more clinically useful or not.Results:1.Comparison of HER-2 interpretation in IBC patients before and after the guideline update.A total of 1543 patients with IBC were enrolled in this study.1419 patients were successfully followed up,124 patients were lost to follow-up,the follow-up rate was 91.96%.Of the 1419 cases,3 were male and 1416 were female,aged 28-85 years,with an average age of 45 years.The median follow-up time was 22.3 months and the follow-up time was 3 to 39 months.In this study,FISH results from 1419 patients with IBC were reassessed using the 2018 ASCO/CAP HER-2 test guideline.Compared with 2013 and 2018 ASCO/CAP guidelines,the sample of FISH positive cases were 208(14.66%)and 205 cases(14.45%),FISH suspicious cases were 90 cases(6.34%)and 0 cases(0%),FISH negative cases were 1121(79.00%)and 1214(85.55%)cases,a total of 1326.The results of the two guidelines were the same,with a concordance rate of 93.45%.The interpretation of the 93 cases of the two guides was inconsistent,accounting for 6.55%.Among them,3 cases(0.21%)were judged as FISH-positive according to the 2013 guide but were judged as FISH-negative according to the 2018 guide.90 cases(6.34%)were judged as FISH suspicious according to the 2013 guide but were judged as FISH-negative according to the 2018 guide.2.Correlation analysis between HER-2 expression and clinicopathological features.After excluding the cases of anti-HER-2 treatment,the total number of HER-2 positive group was 109 cases,the negative group was 1101 cases,and the difference between the two editions was 83 cases in the two editions of the two versions of the guidelines,the total number of the positive group was 109 cases,the negative group was 1101 cases,the differential group was 83 cases.Multiple logistic regression analysis showed that the negative rate of PR and the high expression rate of Ki-67 in the HER-2 positive group were higher than those in the HER-2 negative group,and the difference was statistically significant.There was no significant difference in the expression of ER,PR and Ki-67 between the negative group and the differential group.Correlation analysis of clinical features among the three groups showed statistically significant differences in TNM stage,vessel tumor embolus,recurrence between FISH groups and PR expression in groups,but there was no significant clinical significance.There was no difference in age distribution and nerve invasion among groups.3.Compare the prognosis and similarity of different groups according to the interpretation of the two guidelines.Single factor survival analysis was performed by Kaplan -Meier method and survival curve was drawn to study the disease-free survival rate of the patients.The overall survival curve of the differential group was more similar to that of the negative group.Conclusions:1.2018 guideline eliminates the suspicious interpretation of HER-2.2.Compared with the 2013 guideline,there is an increased HER-2 negative rate in patients according to version 2018.3.FISH-positive patients have more clinical features of tumor invasion than the negative and differential groups.4.The clinical features and prognosis of patients who were change the FISH result to FISH-negative by 2018 guideline is closer to FISH-negative patients,indicating that the 2018 guideline criteria are more accurate and have better clinical applicability. |
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