A prospective multicenter study of HER-2/neu status in human breast cancer patients of mainland China: comparison of fluorescence in situ hybridization and immunohistochemistry
10.3760/cma.j.issn.1009-9158.2010.07.015
- VernacularTitle:应用FISH和IHC技术检测中国乳腺癌患者HER-2基因状态及蛋白表达的前瞻性多中心研究
- Author:
Xiaohong HAN
;
Yuankai SHI
;
Li MA
;
Zheng Lü
;
Hongying YANG
;
Jiarui YAO
;
Jian LI
;
Bo LI
;
Yan QIN
- Publication Type:Journal Article
- Keywords:
Breast neoplasms;
Genes,erbB-2;
Receptor,erbB-2;
In situ hybridization,fluorescence;
Immunohistochemistry;
Multicenter study
- From:
Chinese Journal of Laboratory Medicine
2010;33(7):655-662
- CountryChina
- Language:Chinese
-
Abstract:
Objective To investigate the expression of the HER-2 in human breast carcinomas by comparing the concordance between IHC staining and FISH, and analyze the relationship between the gene expression of HER-2/neu and clinical characteristics of patients. Methods A prospective clinical trial was performed involving a large multicenter patients' samples. Totally 3 249 breast cancer samples were collected from October 2007 to September 2009 in 73 hospitals across mainland China. HER-2 status was assessed by both IHC and FISH using formalin-fixed paraffin sections of consecutive tumor samples. The relationship between the expression of HER-2/neu gene and clinical parameters was analyzed using statistical methods. Results HER-2/neu was detected by FISH in 42.6% (1342/3149) of cases, whereas IHC analysis found 46. 9% (1477/3149) of cases to be HER-2/neu positive (2 +/3 + ). A higher concordance was observed in 94. 1% (892/948) of the patients with scores of 3 + and 89. 9% (660/734) with scores of 0 + by IHC, but relatively low concordance was also observed in 71. 0% (514/725) of patients with scores of 1 + and 55. 9% (415/742) in scores of 2 + by IHC. HER-2/neu gene amplification was associated with negativity of estrogen receptor and progesterone receptor (r = 0. 45, P < 0.01) , high histological grade ( r = 0. 51,P<0.01), more than 4 positive lymph nodes (r =0. 35, P<0.01), advanced stage (r=0. 33, P< 0. 01) , large tumor size ( > 2 cm, r = 0. 38, P < 0. 01 ) , postmenopause (r = 0. 24, P < 0. 01). No statistically significant relationship was found between HER-2 gene status and the other variables including age(r=0.36, P = 0.068), CA125 (r=0.11, P=0.722) or CA153 (r = 0. 23, P=0.45) protein status, lymph node involvement (r=0. 15, P =0. 18), CEA (r = 0.22, P=0.074) , number stage of tumor (r = 0. 21, P = 0.056 ) and blood vessel invasion (r = 0. 12, P = 0. 133 ). Conclusions The comparison of IHC and FISH demonstrated an excellent correlation of HER-2/neu overexpression and gene amplification. The results availabledemonstrate that FISH-analysis as a gold standard should be performed to guide reasonable clinical treatment.
