Ruohong Shui1, Xizi Liang1, Xiaomei Li2, Yueping Liu3, Huixiang Li4, Enwei Xu5, Zhang Zhang6, Yuane Lian7, Shuangping Guo8, Min Yao9, Hanjin Yang10, Fangping Xu11, Yiqiang Liu12, Ju Liu13, Deyu Guo14, Kuansong Wang15, Jinfan Li16, Yun Ma17, Jingmei Wang18, Jie Shi19, Hong Bu6, Wentao Yang20. 1. Department of Pathology, Fudan University Shanghai Cancer Center, Shanghai, China; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China. 2. Department of Pathology, Harbin Medical University Cancer Hospital, Harbin, Heilongjiang, China. 3. Department of Pathology, Fourth Center of Hebei Medical University, Shijiazhuang, Hebei, China. 4. Department of Pathology, The First Affiliated Center of Zhengzhou University, Zhengzhou, Henan, China. 5. Department of Pathology, Shanxi Provincial Cancer Center, Taiyuan, Shanxi, China. 6. Department of Pathology, West China Center Sichuan University, Chengdu, Sichuan, China. 7. Department of Pathology, Fujian Medical University Union Hospital, Fuzhou, Fujian, China. 8. Department of Pathology, Xijing Center Fourth Military Medical University, Xi'an, Shaanxi, China. 9. Department of Pathology, The Second Center of Jilin University, Changchun, Jilin, China. 10. Department of Pathology, The First Affiliated Center Zhejiang University, Hangzhou, Zhejiang, China. 11. Department of Pathology, Guangdong General Center, Guangzhou, Guangdong, China. 12. Department of Pathology, Beijing Cancer Center, Beijing, China. 13. Department of Pathology, Zhongshan Center Fudan University, Shanghai, China. 14. Department of Pathology, Southwest Center, The Third Military Medical University, Chongqing, China. 15. Department of Pathology, Xiangya Center, Central South University, Changsha, Hunan, China. 16. Department of Pathology, The Second Affiliated Center of Zhejiang University School of Medicine, Hangzhou, Zhejiang, China. 17. Department of Pathology, Affiliated Tumor Center, Guangxi Medical University, Nanning, Guangxi, China. 18. Department of Pathology, Nanjing Drum Tower Center, Nanjing, Jiangsu, China. 19. Department of Pathology, Peking Union Medical College Center, Beijing, China. 20. Department of Pathology, Fudan University Shanghai Cancer Center, Shanghai, China; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China. Electronic address: yangwt2000@163.com.
Abstract
INTRODUCTION: We evaluated the current status of hormone receptor (HR) and human epidermal growth factor receptor 2 (HER2) detection in invasive breast carcinoma (IBC) in various laboratories across China. MATERIALS AND METHODS: The Breast Pathology Study Group of the Chinese Society of Pathologists collected HR and HER2 data from 12,467 IBC cases from 19 representative clinical centers in China. The data from every center were compared with the pooled data from the other centers. RESULTS: The assessment of HR status showed that the overall positive estrogen receptor (ER) and progesterone receptor (PR) rates were 71.7% and 63.7% (range, 60.9%-87.9% and 43.9%-84.8%), respectively. The ER results in 3 centers and the PR results in 6 centers were outside the 99.5% confidence interval and were considered to be outliers (P < .0005). Of the 12,467 cases, 62.4% were ER+/PR+, 9.3% were ER+/PR-, 1.3% were ER-/PR+, and 27.0% were ER-/PR-. The assessment of HER2 status showed that the overall positive rate of HER2 (with a definition of immunohistochemistry [IHC] 3+ or IHC2+/ in situ hybridization-positive) was 24.7% (range, 13.7%-35.7%) in each center. Three centers were outside the 99.5% confidence interval and were considered to be outliers (P < .0005). The proportion of HER2 IHC3+ was 21.1%. The positive rates of HER2 gene amplification in IHC 0/1+, 2+, 3+ cases were 2.0%, 17.6%, and 85.9%, respectively. CONCLUSIONS: As the largest study of HR and HER2 status in Chinese patients with IBC, the data from the present study have indicated that the overall rates of HR and HER2 were comparable to those reported in previous studies. However, the rates varied among the laboratories. Individual centers had not met the target values, and they need to improve the detection.
INTRODUCTION: We evaluated the current status of hormone receptor (HR) and humanepidermal growth factor receptor 2 (HER2) detection in invasive breast carcinoma (IBC) in various laboratories across China. MATERIALS AND METHODS: The Breast Pathology Study Group of the Chinese Society of Pathologists collected HR and HER2 data from 12,467 IBC cases from 19 representative clinical centers in China. The data from every center were compared with the pooled data from the other centers. RESULTS: The assessment of HR status showed that the overall positive estrogen receptor (ER) and progesterone receptor (PR) rates were 71.7% and 63.7% (range, 60.9%-87.9% and 43.9%-84.8%), respectively. The ER results in 3 centers and the PR results in 6 centers were outside the 99.5% confidence interval and were considered to be outliers (P < .0005). Of the 12,467 cases, 62.4% were ER+/PR+, 9.3% were ER+/PR-, 1.3% were ER-/PR+, and 27.0% were ER-/PR-. The assessment of HER2 status showed that the overall positive rate of HER2 (with a definition of immunohistochemistry [IHC] 3+ or IHC2+/ in situ hybridization-positive) was 24.7% (range, 13.7%-35.7%) in each center. Three centers were outside the 99.5% confidence interval and were considered to be outliers (P < .0005). The proportion of HER2 IHC3+ was 21.1%. The positive rates of HER2 gene amplification in IHC 0/1+, 2+, 3+ cases were 2.0%, 17.6%, and 85.9%, respectively. CONCLUSIONS: As the largest study of HR and HER2 status in Chinese patients with IBC, the data from the present study have indicated that the overall rates of HR and HER2 were comparable to those reported in previous studies. However, the rates varied among the laboratories. Individual centers had not met the target values, and they need to improve the detection.
Authors: Serena Di Cosimo; Eliana La Rocca; Silva Ljevar; Maria Carmen De Santis; Marta Bini; Vera Cappelletti; Marta Valenti; Paolo Baili; Filippo G de Braud; Secondo Folli; Gianfranco Scaperrotta; Chiara Volpi; Andrea Vingiani; Claudio Vernieri; Paolo Verderio; Rosalba Miceli; Giancarlo Pruneri Journal: Front Mol Biosci Date: 2022-09-26