| Breast cancer is a common malignancy in our country, and severely threatens women' s lives. Its clinical outcome will be affected by many factors. As a clinically important prognostic factor, HER-2/neu (c-erbB-2) gene overexpressing is a prognostic marker of poor clinical outcome in node-negative and node-positive breast cancer and a predictor of lack of responsiveness to tamoxifen antiestrogen therapy and responsiveness to adjuvant doxorubicin chemotherapy. Thus, HER-2/neu is considered to be an important issue. And, it is important for therapy to assay HER-2/neu abnormalities.Many researches between HER-2/neu and breast cancer have been done, but some questions are still present. First, the number of samples of the researches about states of HER-2/neu expression in breast cancer in country and abroad had been few, thus, their results were different, even reverse. Second, many researches about HER-2/neu expression in breast cancer have been present, but the result had much difference in the expression level, this difference was caused by different detecting kit and testing method, further research is necessary to establish accurate HER-2/neu expression level. The last, whether the HER-2/neu expression is a predictive factor in breast cancer treatment clinically or not is still controversy, especially to those patients with HER-2/neu overexpressing and lymph node-negative, how to evaluate their prognosis and to make treatment strategy have not been found.To solve the problems mentioned above, we select HER-2/neu gene as study target to establish HER-2/neu prognostic significance and explore feasibility of therapy strategy for breast cancer. We adopt immunohistochemical approach (IHC) to detect the expression of HER-2/neu gene in pathological specimen in breast cancer, to elucidate the expression of HER-2/neu gene in breast cancer, and to analyze the relationship between the HER-2/neu gene and prognosis of patients in breast cancer, to elucidate the prognostic significance of HER-2/neu gene;to study the relationship between HER-2/neu gene, age, menstrual status, ER, PR, pathological staging, histological grading, axillary' s lymph node status and prognosis of patients with breast cancer., To discuss their correlations and the probability of becoming the prognostic index in breast cancer;to study the relationship between the different expression of HER-2/neu gene and different status of axillary' s lymph node metastasis and prognosis, to discuss the significance of the expression status of HER-2/neu gene to prognosis in different lymph node metastasis status, to offer theoretical foundation to clinical prognostic evaluation and therapeutic protocol design. Part 1. The expression of HER-2 gene and other factors and the relativity of various index signs.Objective: To realize the significance of the expression status of HER-2/neu gene to prognosis.Case selection: 711 pathological sample of breast cancer patientsreceiving hasted or modified mastectomy with complete case report and follow-up information Between Jan. 1993 and Dec. 1994 in Tianjin Cancer Hospital.Method: All the pathological dry of 711 breast cancer sample were embedded, sections were cut at 4um, immunohistochemical staining were done to detect the expression of HER-2/neu gene. Results were decided according to the method the kit recommended, different expressions of HER-2/neu gene and other factors affecting prognosis were statistically analyzed with SPSS12.0 package.Results: 1. Of all the 711 primary breast cancer patients, the overall HER-2/neu positive rate were 25.17%, HER-2/neu+ was 11.25%, HER-2/neu++ was 6. 75%, HER-2/neu+++ was 7.17%.2. HER-2/neu gene expression had positive correlations with tumor size, with statistically significant difference (p=0. 000);and had positive correlations with histological grading, with statistically significant difference (p=0. 000);and had correlations with estrogen receptors, with statistically significant difference(p=0. 000), negative estrogen receptors had higher HER-2/neu positive rate than positive estrogen receptors;and had correlations with axillary lymph node metastasis, with statistically significant difference(p=0. 017), positive axillary lymph node had higher HER-2/neu positive rate than negative axillary lymph node;and had no correlations with menopausal status, progesterone receptor status, pathological typeand age, with no statistic difference.3. Different expression of HER-2/neu had correlations with postoperative 10 years survival rate, with statistically significant difference(p=0.000), negative HER-2/neu(-) group and positive HER-2/neu(+) group, HER-2/neu(++) group and HER-2/neu(+++) group had no statistic difference, HER-2/neu (++) and HER-2/neu(+++) group had lower 10 years survival rate than HER-2/neu (-) and HER-2/neu(+) group. Part 2. The relationship between different expression of HER-2/neu in breast cancer patients and axillary lymph node metatistic status.Objective: To understand the expression of HER-2/neu in different axillary lymph node metatistic status and its effection on prognosis.Case selection: 711 pathological sample of breast cancer patients receiving hasted or modified mastectomy with complete case report and follow-up information Between Jan. 1993 and Dec. 1994 in Tianjin Cancer Hospital.Methods: According to the pathological report information in 711 cases of primary breast cancer, and summarize the axillary lymph node metatastic status of each patient, and embedded all the pathological dry of 711 breast cancer sample, and sections were cut at 4um, immunohistochemical staining were done to detect the expression of HER-2/neu gene.Results were decided according to the method the kit recommended. At last, different expressions of HER-2/neu gene, axillary lymph node metastatic number and 10 years survival rate werestatistically analyzed with SPSS12.0 package, and draw Keplier meir survival curves to compare between groups.Results: l.Of 711 primary breast cancer cases, the overall positive rate of axillary lymph node metastasis was46. 98%, with 13 positive rate was 18. 42%, 49 positive rate was 11. 25%, more than 10 positive rate was 17.31%.2. There were no correlations between HER-2expression(-) (++) and axillary lymph node metatastic number, with no statistic difference(p>0.05).3.There was correlations between HER-2 expression (+++) and axillary lymph node metatastic number, with statistic significance(p=0. 008), axillary lymph node negative and more than 10 lymph node positive group, 13 lymph node positive and more than 10 lymph node positive group had significant difference, with statistic significance, other groups had no significant difference.4. The 10 years overall survial rate of different expression of HER-2 in negative axillary lymph node patients were89. 73%, 97. 87%, 29. 41% and 19.05%, there were difference between groups, with statistic significance(p=0. 000), 10 years overall survival rate in HER-2 expression(-) (+) significantly higher than HER-2 expression (++) (+++) group.5. The 10 years overall survial rate of different expression of HER-2 in 1 3 axillary lymph node positive patients were76. 47%, 83. 33%, 33. 33% and 0. 00%, there were difference between groups, with statistic significance(p=0.000), 10 years overall survival rate in HER-2 expression(-) (+) significantly higher than HER-2 expression(++)+++ group.6. The 10 years overall survial rate of different expression of HER-2 in 4 - 9 axillary lymph node positive patients were 56. 36%, 50. 00%, 37. 50% and 22.22%, there were no difference between groups(p=0. 244), with no statistic significance.7. The 10 years overall survial rate of different expression of HER-2 in 4 9 axillary lymph node positive patients were 25. 30%, 30. 77% , 9.09% and 0. 00%, there were no difference between groups(p=0. 077), with no statistic significance.
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