Abstract:
Objectives: This study aims to systematically investigate the association between the occurrence of immune-related adverse events (irAEs) and treatment efficacy in patients with gastroesophageal tumors receiving immune checkpoint inhibitor (ICIs) therapy, and to clarify the clinical value of irAEs as efficacy prediction indicators.
Methods: A retrospective cohort design was adopted, enrolling 120 patients with gastroesophageal tumors from Affiliated Hospital of Qingdao University between October 2021 and August 2025. The patients were divided into a monotherapy group and a combination therapy group. Efficacy was evaluated in accordance with the RECIST 1.1 criteria, while irAEs were recorded based on the CTCAE Version 5.0. Chi-square test, Logistic regression, and other statistical methods were used to analyze the association between irAEs and treatment efficacy.
Results: The disease control rate (DCR, 48.91%) and objective response rate (ORR, 87.88%) of patients with irAEs were significantly higher than those of patients without irAEs (both P < 0.05). The absence of irAEs (OR=5.651) and TNM stage IV (OR=3.624) were independent risk factors affecting DCR. Additionally, second-line or later treatment lines, TNM stage IV, and the absence of irAEs significantly reduced ORR (OR = 6.327, 5.694, and 4.265, respectively).
Conclusion: Patients who developed irAEs exhibited significantly higher DCR and ORR. The absence of irAEs and TNM stage IV were independent risk factors influencing the therapeutic efficacy of ICI therapy in patients with gastroesophageal tumors.