Akademik Veri Yönetim Sistemi
ESMO Immuno-Oncology Congress 2025, London, İngiltere, 10 - 12 Aralık 2025, ss.30, (Özet Bildiri)
Background: Immune-mediated upper gastrointestinal (IMUGI) toxicities refer to inflammatory damage of oesophagus, stomach and duodenum following immune checkpoint inhibitors (ICIs) use. Diagnosis is often challenging due to vague and nonspecific symptoms. Therefore, we aim to assess characteristics of patients with im-upper GI toxicity reported in the FAERS system. Methods: We retrospectively searched the data of patients receiving ICIs. We included a total of 132 patients with IMUGI toxicity by using keywords “immunemediated gastritis” and “immune-mediated oesophagitis”. We evaluated the associations between IMUGI toxicities and variables including age, gender, treatment regimens used, and concurrent immune-mediated adverse events. Serious adverse events were considered as requiring hospitalization or deemed life-threatening. Categorical variables were compared using either the chi-square test or Fisher’s exact test, depending on the sample size and the distribution of expected values within the contingency tables. To evaluate the potential association between ICIs and specific upper GI toxicity events of interest, a disproportionality analysis was conducted using the Reporting Odds Ratio (ROR) method. A signal was considered statistically significant when the lower bound of the 95% confidence interval (CI) for the ROR exceeded 1.0, indicating a potential increased risk. Results: Among 132 patients, 26 developed im-esophagitis, 100 patients developed im-gastritis, and six had both. Anti-PD-1 agents were associated with higher incidence of IMUGI toxicities compared to anti-PD-L1 agents (p = 0.001, ROR = 3.83) Hospitalization rates were higher in patients receiving anti-PD-1 therapy compared to those treated with anti-PD-L1 (p = 0.007). A higher incidence of hospitalization rate was observed in patients receiving concurrent chemotherapy (71.4%) than in those did not receive (36.1%) (p = 0.006, ROR = 3.41). Conclusions: Anti-PD-1 use may be associated with higher incidence of IMUGI toxicities and addition of chemotherapy may lead to more serious toxicities.