Mendjargal, Adilsaikhan

Background: Globally, gastric cancer accounts for 1,089,000 new cases and 769,000 deaths annually, ranking fifth in overall cancer incidence and third in cancer-related mortality. The aim to determine HER2 expression in patients with gastric cancer and to evaluate its correlation with clinical and immunological biomarkers, as well as the need for further laboratory diagnostics. Aim: To determine HER2 expression in patients with gastric cancer and to evaluate its association with clinical and immunological biomarkers, as well as the potential need for further laboratory diagnostics. Materials and Methods: A retrospective study was conducted using archived materials from patients with gastric cancer at the Clinical Pathology, Molecular Genetics, and Pathology Laboratories of the National Cancer Center of Mongolia, covering the period from 2019 to June 2025. HER2 protein expression in tumor tissue was assessed using immunohistochemistry (IHC), and chromogenic in situ hybridization (CISH-HER2) was employed to confirm gene amplification. Statistical analysis was performed using the Prisma-10 software. Results: In our study, among 210 cases of gastric cancer evaluated by IHC for HER2, 46 (21.9%) were HER2-positive and 164 (78.1%) were HER2-negative. When comparing patients with gastric cancer stratified into HER2 1+ (negative) and HER2 3+ (positive) groups, no statistically significant differences (p < 0.05) were observed in age, sex, tumor location (surgically resected tissue), morphology, or disease stage. However, a higher proportion of males was noted in the HER2 3+ group (80.9%), though this did not reach statistical significance (p = 0.0879). Significant associations were found with tumor markers. Elevated serum CA-72-4 (>5 ng/mL) was more frequent in the HER2 3+ group (58.8%; p = 0.0069). In contrast, elevated CA-19-9 (>35 U/mL) was more common in the HER2 1+ group (93.5%; p = 0.0117), and elevated CEA (>6.9 U/mL) was also predominant in the HER2 1+ group (90.6%; p = 0.002). These findings suggest that HER2 3+ status predominates in cases with elevated CA-72-4, which may influence diagnostic strategies and HER2-targeted therapies (e.g., trastuzumab). Conversely, elevated CA-19-9 and CEA were more associated with HER2 1+ status, indicating a need for further detailed investigation of these markers in relation to HER2 expression. In patients evaluated by CISH for HER2 expression, stratification into HER2-positive and HER2-negative groups revealed no statistically significant differences (p < 0.05) in age, sex, tumor location, morphology, stage, or serum tumor markers (CA-72-4, CA-19-9, CEA). This suggests that HER2 status (positive/negative) may be independent of these variables. Although HER2 positivity was higher in poorly differentiated tumors (48% vs. 30.6% negative; p=0.1414) and in stage IV disease (50% vs. 39.3% negative; p=0.2607), these differences were not statistically significant. Elevated serum markers (CA-72-4, CA-19-9, CEA) were observed but showed no significant correlation with HER2 status. Conclusion: Determining the molecular profile of gastric cancer patients can significantly contribute to refining clinical diagnosis, developing treatment strategies, enhancing therapeutic outcomes, and improving patients’ quality of life.

Mendjargal, Adilsaikhan

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