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HER2 Status in Gastric and Gastroesophageal Junction Cancer Assessed by Local and Central Laboratories: Chinese Results of the HER-EAGLE Study

Trastuzumab has been approved for human epidermal growth factor receptor 2 (HER2)-positive advanced gastric and gastroesophageal junction cancers (GC and GJC) in combination with chemotherapy. The aim of this HER2 early/advanced gastric epidemiology (HER-EAGLE) study was to evaluate the frequency of...

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Autores principales: Huang, Dan, Lu, Ning, Fan, Qinhe, Sheng, Weiqi, Bu, Hong, Jin, Xiaolong, Li, Guimei, Liu, Yanhui, Li, Xianghong, Sun, Wenyong, Zhang, Huizhong, Li, Xiaobing, Zhou, Zongguang, Yan, Min, Wang, Xuan, Sha, Weihong, Ji, Jiafu, Cheng, Xiangdong, Zhou, Zhiwei, Xu, Jianming, Du, Xiang
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2013
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3828190/
https://www.ncbi.nlm.nih.gov/pubmed/24244671
http://dx.doi.org/10.1371/journal.pone.0080290
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author Huang, Dan
Lu, Ning
Fan, Qinhe
Sheng, Weiqi
Bu, Hong
Jin, Xiaolong
Li, Guimei
Liu, Yanhui
Li, Xianghong
Sun, Wenyong
Zhang, Huizhong
Li, Xiaobing
Zhou, Zongguang
Yan, Min
Wang, Xuan
Sha, Weihong
Ji, Jiafu
Cheng, Xiangdong
Zhou, Zhiwei
Xu, Jianming
Du, Xiang
author_facet Huang, Dan
Lu, Ning
Fan, Qinhe
Sheng, Weiqi
Bu, Hong
Jin, Xiaolong
Li, Guimei
Liu, Yanhui
Li, Xianghong
Sun, Wenyong
Zhang, Huizhong
Li, Xiaobing
Zhou, Zongguang
Yan, Min
Wang, Xuan
Sha, Weihong
Ji, Jiafu
Cheng, Xiangdong
Zhou, Zhiwei
Xu, Jianming
Du, Xiang
author_sort Huang, Dan
collection PubMed
description Trastuzumab has been approved for human epidermal growth factor receptor 2 (HER2)-positive advanced gastric and gastroesophageal junction cancers (GC and GJC) in combination with chemotherapy. The aim of this HER2 early/advanced gastric epidemiology (HER-EAGLE) study was to evaluate the frequency of HER2 over-expression and to evaluate agreement on HER2 status assessment in GC and GJC patients in local laboratories versus a central laboratory in China. Tumor samples from 734 GC or GJC patients who were enrolled at 11 different hospitals in China were examined. HER2 status was assessed by immunohistochemistry (IHC), and followed by dual-color silver-enhanced in Situ hybridization (DSISH) in IHC 2+ cases. Clinicopathologic characteristics were collected from all of the patients. HER2-positive tumors were identified in 12.0% (88/734) of the GC and GJC cases. There were significantly higher rates of HER2 positivity in patients with GJC (GJC: 18.1%, GC: 9.7%, P=0.002), and intestinal-type cancers using the Lauren classification (intestinal: 23.6%, diffuse/mixed: 4.3%, P<0.0001). No significant difference in HER2 positivity was identified between resection and biopsy samples, or between early and advanced disease stages. The agreement between local laboratories and the central laboratory on HER2 status scoring was good (kappa=0.86). The main reason of HER2 status discordance between local and the central laboratories was IHC result mis-interpretation in local laboratories. These results suggest that IHC followed by DSISH testing is an accurate and cost-effective procedure in China.
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spelling pubmed-38281902013-11-16 HER2 Status in Gastric and Gastroesophageal Junction Cancer Assessed by Local and Central Laboratories: Chinese Results of the HER-EAGLE Study Huang, Dan Lu, Ning Fan, Qinhe Sheng, Weiqi Bu, Hong Jin, Xiaolong Li, Guimei Liu, Yanhui Li, Xianghong Sun, Wenyong Zhang, Huizhong Li, Xiaobing Zhou, Zongguang Yan, Min Wang, Xuan Sha, Weihong Ji, Jiafu Cheng, Xiangdong Zhou, Zhiwei Xu, Jianming Du, Xiang PLoS One Research Article Trastuzumab has been approved for human epidermal growth factor receptor 2 (HER2)-positive advanced gastric and gastroesophageal junction cancers (GC and GJC) in combination with chemotherapy. The aim of this HER2 early/advanced gastric epidemiology (HER-EAGLE) study was to evaluate the frequency of HER2 over-expression and to evaluate agreement on HER2 status assessment in GC and GJC patients in local laboratories versus a central laboratory in China. Tumor samples from 734 GC or GJC patients who were enrolled at 11 different hospitals in China were examined. HER2 status was assessed by immunohistochemistry (IHC), and followed by dual-color silver-enhanced in Situ hybridization (DSISH) in IHC 2+ cases. Clinicopathologic characteristics were collected from all of the patients. HER2-positive tumors were identified in 12.0% (88/734) of the GC and GJC cases. There were significantly higher rates of HER2 positivity in patients with GJC (GJC: 18.1%, GC: 9.7%, P=0.002), and intestinal-type cancers using the Lauren classification (intestinal: 23.6%, diffuse/mixed: 4.3%, P<0.0001). No significant difference in HER2 positivity was identified between resection and biopsy samples, or between early and advanced disease stages. The agreement between local laboratories and the central laboratory on HER2 status scoring was good (kappa=0.86). The main reason of HER2 status discordance between local and the central laboratories was IHC result mis-interpretation in local laboratories. These results suggest that IHC followed by DSISH testing is an accurate and cost-effective procedure in China. Public Library of Science 2013-11-14 /pmc/articles/PMC3828190/ /pubmed/24244671 http://dx.doi.org/10.1371/journal.pone.0080290 Text en © 2013 Huang et al http://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are properly credited.
spellingShingle Research Article
Huang, Dan
Lu, Ning
Fan, Qinhe
Sheng, Weiqi
Bu, Hong
Jin, Xiaolong
Li, Guimei
Liu, Yanhui
Li, Xianghong
Sun, Wenyong
Zhang, Huizhong
Li, Xiaobing
Zhou, Zongguang
Yan, Min
Wang, Xuan
Sha, Weihong
Ji, Jiafu
Cheng, Xiangdong
Zhou, Zhiwei
Xu, Jianming
Du, Xiang
HER2 Status in Gastric and Gastroesophageal Junction Cancer Assessed by Local and Central Laboratories: Chinese Results of the HER-EAGLE Study
title HER2 Status in Gastric and Gastroesophageal Junction Cancer Assessed by Local and Central Laboratories: Chinese Results of the HER-EAGLE Study
title_full HER2 Status in Gastric and Gastroesophageal Junction Cancer Assessed by Local and Central Laboratories: Chinese Results of the HER-EAGLE Study
title_fullStr HER2 Status in Gastric and Gastroesophageal Junction Cancer Assessed by Local and Central Laboratories: Chinese Results of the HER-EAGLE Study
title_full_unstemmed HER2 Status in Gastric and Gastroesophageal Junction Cancer Assessed by Local and Central Laboratories: Chinese Results of the HER-EAGLE Study
title_short HER2 Status in Gastric and Gastroesophageal Junction Cancer Assessed by Local and Central Laboratories: Chinese Results of the HER-EAGLE Study
title_sort her2 status in gastric and gastroesophageal junction cancer assessed by local and central laboratories: chinese results of the her-eagle study
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3828190/
https://www.ncbi.nlm.nih.gov/pubmed/24244671
http://dx.doi.org/10.1371/journal.pone.0080290
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