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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

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          Abstract

          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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          Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial.

          Trastuzumab, a monoclonal antibody against human epidermal growth factor receptor 2 (HER2; also known as ERBB2), was investigated in combination with chemotherapy for first-line treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer. ToGA (Trastuzumab for Gastric Cancer) was an open-label, international, phase 3, randomised controlled trial undertaken in 122 centres in 24 countries. Patients with gastric or gastro-oesophageal junction cancer were eligible for inclusion if their tumours showed overexpression of HER2 protein by immunohistochemistry or gene amplification by fluorescence in-situ hybridisation. Participants were randomly assigned in a 1:1 ratio to receive a chemotherapy regimen consisting of capecitabine plus cisplatin or fluorouracil plus cisplatin given every 3 weeks for six cycles or chemotherapy in combination with intravenous trastuzumab. Allocation was by block randomisation stratified by Eastern Cooperative Oncology Group performance status, chemotherapy regimen, extent of disease, primary cancer site, and measurability of disease, implemented with a central interactive voice recognition system. The primary endpoint was overall survival in all randomised patients who received study medication at least once. This trial is registered with ClinicalTrials.gov, number NCT01041404. 594 patients were randomly assigned to study treatment (trastuzumab plus chemotherapy, n=298; chemotherapy alone, n=296), of whom 584 were included in the primary analysis (n=294; n=290). Median follow-up was 18.6 months (IQR 11-25) in the trastuzumab plus chemotherapy group and 17.1 months (9-25) in the chemotherapy alone group. Median overall survival was 13.8 months (95% CI 12-16) in those assigned to trastuzumab plus chemotherapy compared with 11.1 months (10-13) in those assigned to chemotherapy alone (hazard ratio 0.74; 95% CI 0.60-0.91; p=0.0046). The most common adverse events in both groups were nausea (trastuzumab plus chemotherapy, 197 [67%] vs chemotherapy alone, 184 [63%]), vomiting (147 [50%] vs 134 [46%]), and neutropenia (157 [53%] vs 165 [57%]). Rates of overall grade 3 or 4 adverse events (201 [68%] vs 198 [68%]) and cardiac adverse events (17 [6%] vs 18 [6%]) did not differ between groups. Trastuzumab in combination with chemotherapy can be considered as a new standard option for patients with HER2-positive advanced gastric or gastro-oesophageal junction cancer. F Hoffmann-La Roche. Copyright 2010 Elsevier Ltd. All rights reserved.
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            Global cancer statistics

             A. JEMAL,  F BRAY,  MM Center (2011)
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              Global cancer statistics

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                Author and article information

                Contributors
                Role: Editor
                Journal
                PLoS One
                PLoS ONE
                plos
                plosone
                PLoS ONE
                Public Library of Science (San Francisco, USA )
                1932-6203
                2013
                14 November 2013
                : 8
                : 11
                Affiliations
                [1 ]Department of Pathology, Cancer Center of Fudan University; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China
                [2 ]Department of Pathology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing, China
                [3 ]Department of Pathology, Jiangsu Province Hospital, Nanjing, China
                [4 ]Department of Pathology, West China Hospital of Sichuan University, Chengdu, China
                [5 ]Department of Pathology, Shanghai Jiao Tong University School of Medicine Ruijing Hospital, Shanghai, China
                [6 ]Department of Pathology, PLA 81 Hospital, Nanjing, China,
                [7 ]Department of Pathology, Guangdong General Hospital, Guangzhou, China
                [8 ]Department of Pathology, Beijing Cancer Hospital, Beijing, China
                [9 ]Department of Pathology, Zhejiang Cancer Hospital, Hangzhou, China
                [10 ]Department of Pathology, Sun Yat-sen University Cancer Center, Guangzhou, China
                [11 ]Department of Pathology, PLA 307 Hospital, Beijing, China
                [12 ]Center of Gastrointestinal Surgery, West China Hospital of Sichuan University, Chengdu, China
                [13 ]Department of Surgery and Shanghai Institute of Digestive Surgery, Shanghai Jiao Tong University School of Medicine Ruijing Hospital, Shanghai, China
                [14 ]Department of Surgery, PLA 81 Hospital, Nanjing, China,
                [15 ]Department of Gastroenterology, Guangdong General Hospital, Guangzhou, China
                [16 ]Department of Gastrointestinal Surgery, Beijing Cancer Hospital, Beijing, China
                [17 ]Department of Abdominal Surgery, Zhejiang Cancer Hospital, Hangzhou, China
                [18 ]Department of Gastric and Pancreatic Surgery, Sun Yat-sen University Cancer Center, Guangzhou, China
                [19 ]Department of Gastrointestinal Oncology, PLA 307 Hospital, Beijing, China;
                The Chinese University of Hong Kong, Hong Kong
                Author notes

                Competing Interests: The authors have declared that no competing interests exist.

                Conceived and designed the experiments: XD. Performed the experiments: DH NL QF W. Sheng HB XJ GL YL Xianghong Li W. Sun HZ Xiaobing Li Zongguang Zhou MY XW W. Sha JJ XC Zhiwei Zhou JX. Analyzed the data: DH NL W. Sheng HB XJ GL YL Xianghong Li W. Sun HZ Xiaobing Li Zongguang Zhou XD. Wrote the manuscript: DH.

                Article
                PONE-D-13-25764
                10.1371/journal.pone.0080290
                3828190

                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 credited.

                Funding
                This study was sponsored by Shanghai ROCHE pharmaceuticals Ltd. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. This does not alter the authors' adherence to all the PLOS ONE policies on sharing data and materials.
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