HER2 Status in Gastric and Gastroesophageal Junction Cancer: Results of the Large, Multinational HER-EAGLE Study

Woo-Ho Kim, Lourdes Gomez-Izquierdo, Felip Vilardell, Kent-Man Chu, Geneviève Soucy, Lucas V Dos Santos, Geneviève Monges, Giuseppe Viale, Maria José Brito, Stuart Osborne, Johannes Noé, Xiang Du

Research output: Contribution to journalArticle

Abstract

Human epidermal growth factor receptor 2 (HER2) dysregulation is associated with tumorigenesis in gastric/gastroesophageal junction cancer; however, the number of patients with HER2-positive disease is unclear, possibly due to differing scoring criteria/assays. Data are also lacking for early disease. We aimed to assess the HER2-positivity rate using approved testing criteria in a large, real-life multinational population. HER2-positivity was defined as an immunohistochemistry staining score of 3+, or immunohistochemistry 2+ and HER2 amplification detected by in situ hybridization. A total of 4949 patients were enrolled and results showed that 14.2% of 4920 samples with immunohistochemistry results were HER2-positive. HER2-positivity was significantly higher in males (16.1% vs. 9.6% in females), in gastroesophageal versus stomach tumors (22.1% vs. 12.9%), in biopsy versus surgical samples (18.3% vs. 13.0%), in intestinal tumor subtypes versus diffuse (21.5% vs. 4.8%) and mixed types (21.5% vs. 8.5%) (P<0.001), in mixed versus diffuse types (8.5% vs. 4.8%), and in "other" versus diffuse types (11.7% vs. 4.8%; P=0.002). There were no significant differences between stages. Patients in the youngest age percentile had significantly lower HER2-positivity rates than patients in the remaining percentiles (9.2% vs. 15.9%, 15.7%, and 15.1%; P<0.001). HER2-positivity was highest in France (20.2%) and lowest in Hong Kong (10.4%). In conclusion, HER-EAGLE, the first study of its kind to be conducted in a large, multinational population of almost 5000 patients, gives valuable insights into the real-world HER2-positivity rate in a gastric/gastroesophageal junction cancer patient population not selected for disease stage or histology.

Original languageEnglish
Pages (from-to)239-245
Number of pages7
JournalApplied Immunohistochemistry and Molecular Morphology
Volume26
Issue number4
DOIs
Publication statusPublished - Apr 2018

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Esophagogastric Junction
Stomach
Neoplasms
Immunohistochemistry
human ERBB2 protein
Population
Hong Kong
France
In Situ Hybridization
Histology
Carcinogenesis
Staining and Labeling
Biopsy

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HER2 Status in Gastric and Gastroesophageal Junction Cancer : Results of the Large, Multinational HER-EAGLE Study. / Kim, Woo-Ho; Gomez-Izquierdo, Lourdes; Vilardell, Felip; Chu, Kent-Man; Soucy, Geneviève; Dos Santos, Lucas V; Monges, Geneviève; Viale, Giuseppe; Brito, Maria José; Osborne, Stuart; Noé, Johannes; Du, Xiang.

In: Applied Immunohistochemistry and Molecular Morphology, Vol. 26, No. 4, 04.2018, p. 239-245.

Research output: Contribution to journalArticle

Kim, W-H, Gomez-Izquierdo, L, Vilardell, F, Chu, K-M, Soucy, G, Dos Santos, LV, Monges, G, Viale, G, Brito, MJ, Osborne, S, Noé, J & Du, X 2018, 'HER2 Status in Gastric and Gastroesophageal Junction Cancer: Results of the Large, Multinational HER-EAGLE Study', Applied Immunohistochemistry and Molecular Morphology, vol. 26, no. 4, pp. 239-245. https://doi.org/10.1097/PAI.0000000000000423
Kim, Woo-Ho ; Gomez-Izquierdo, Lourdes ; Vilardell, Felip ; Chu, Kent-Man ; Soucy, Geneviève ; Dos Santos, Lucas V ; Monges, Geneviève ; Viale, Giuseppe ; Brito, Maria José ; Osborne, Stuart ; Noé, Johannes ; Du, Xiang. / HER2 Status in Gastric and Gastroesophageal Junction Cancer : Results of the Large, Multinational HER-EAGLE Study. In: Applied Immunohistochemistry and Molecular Morphology. 2018 ; Vol. 26, No. 4. pp. 239-245.
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AU - Vilardell, Felip

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AU - Soucy, Geneviève

AU - Dos Santos, Lucas V

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AB - Human epidermal growth factor receptor 2 (HER2) dysregulation is associated with tumorigenesis in gastric/gastroesophageal junction cancer; however, the number of patients with HER2-positive disease is unclear, possibly due to differing scoring criteria/assays. Data are also lacking for early disease. We aimed to assess the HER2-positivity rate using approved testing criteria in a large, real-life multinational population. HER2-positivity was defined as an immunohistochemistry staining score of 3+, or immunohistochemistry 2+ and HER2 amplification detected by in situ hybridization. A total of 4949 patients were enrolled and results showed that 14.2% of 4920 samples with immunohistochemistry results were HER2-positive. HER2-positivity was significantly higher in males (16.1% vs. 9.6% in females), in gastroesophageal versus stomach tumors (22.1% vs. 12.9%), in biopsy versus surgical samples (18.3% vs. 13.0%), in intestinal tumor subtypes versus diffuse (21.5% vs. 4.8%) and mixed types (21.5% vs. 8.5%) (P<0.001), in mixed versus diffuse types (8.5% vs. 4.8%), and in "other" versus diffuse types (11.7% vs. 4.8%; P=0.002). There were no significant differences between stages. Patients in the youngest age percentile had significantly lower HER2-positivity rates than patients in the remaining percentiles (9.2% vs. 15.9%, 15.7%, and 15.1%; P<0.001). HER2-positivity was highest in France (20.2%) and lowest in Hong Kong (10.4%). In conclusion, HER-EAGLE, the first study of its kind to be conducted in a large, multinational population of almost 5000 patients, gives valuable insights into the real-world HER2-positivity rate in a gastric/gastroesophageal junction cancer patient population not selected for disease stage or histology.

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