Prevalence of Her2-neu status and its clinicopathological association in newly diagnosed gastric cancer patients.

ABSTRACT

BACKGROUND: This study aimed to report the prevalence of HER2-neu in newly diagnosed early or metastatic gastric cancer (GC) patients, to determine the percentage of patients achieving various IHC scores correlating with the ISH results and to establish a database for GC patients in Lebanon. METHODS: This was a national, multicenter, descriptive and cross-sectional study in patients with histologically confirmed early or metastatic GC newly diagnosed. All eligible patients underwent the IHC and ISH tests in a central laboratory. Demographics, medical history and histopathology data were collected. RESULTS: One hundred fifty-seven patients were included (mean age at diagnosis 63 ± 14.1 years) during a 3.5 year period. The prevalence of HER2-neu over expression was 21% (95% CI 15.3-27.4) using ICH and ISH. Agreement between IHC and ISH results was significantly substantial (kappa = 0.681; p-value < 0.001). Over expressed HER2-neu status was significantly associated with high ECOG performance status only. CONCLUSIONS: The prevalence of HER2-neu over expression in newly diagnosed early or metastatic GC patients seemed to be high in Lebanon. The database generated allows to monitor trends in the epidemiology and management of GC.