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Updated: Nov 8, 2025

Predictive Immune Modeling of Solid Tumors
Published on: February 25, 2020
Analysis of risk factors for immune-related adverse events in various solid tumors using real-world data
Keitaro Shimozaki1, Yasutaka Sukawa2, Yasunori Sato3
1Department of Internal Medicine, Division of Gastroenterology & Hepatology, Keio University School of Medicine, Tokyo, 1608582, Japan.
Abstract:
The aim of this study was to determine the risk factors for immune-related adverse events (irAEs) induced by immune checkpoint inhibitors. The authors conducted a retrospective study in which patients with malignant melanoma, non-small-cell lung cancer, gastric cancer or renal cell carcinoma who received anti-PD-1/PD-L1 antibodies were included. Of 247 patients, 118 developed a total of 182 irAEs. In the multivariate Fine-Gray regression analysis, serum albumin level ≥3.6 g/dl (hazard ratio: 1.62; 95% CI: 1.10-2.39; p = 0.015) and history of Type I hypersensitivity reactions (hazard ratio: 1.48; 95% CI: 1.02-2.14; p = 0.037) were significantly associated with the development of irAEs. High serum albumin levels and history of Type I hypersensitivity reactions are risk factors for irAEs.
Insights
High serum albumin and a history of Type I hypersensitivity reactions are key risk factors for immune-related adverse events (irAEs) in patients receiving immune checkpoint inhibitors.
Area of Science:
- Oncology
- Immunology
- Clinical Research
Background:
- Immune checkpoint inhibitors (ICIs) like anti-PD-1/PD-L1 antibodies have revolutionized cancer treatment.
- However, these therapies can trigger immune-related adverse events (irAEs) affecting various organs.
- Identifying patients at higher risk for irAEs is crucial for proactive management.
Purpose of the Study:
- To identify significant risk factors associated with the development of irAEs in cancer patients treated with ICIs.
- To analyze patient data retrospectively to pinpoint predictors of irAEs.
Main Methods:
- Retrospective analysis of 247 patients with malignant melanoma, non-small-cell lung cancer, gastric cancer, or renal cell carcinoma treated with anti-PD-1/PD-L1 antibodies.
- Multivariate Fine-Gray regression analysis was employed to assess risk factors for irAEs.
- Data collected included patient demographics, cancer type, treatment, and occurrence of irAEs.
Main Results:
- A total of 182 irAEs were observed in 118 out of 247 patients.
- Serum albumin level ≥3.6 g/dL was significantly associated with an increased risk of irAEs (HR: 1.62; 95% CI: 1.10-2.39; p=0.015).
- A history of Type I hypersensitivity reactions also emerged as a significant risk factor (HR: 1.48; 95% CI: 1.02-2.14; p=0.037).
Conclusions:
- Elevated serum albumin levels and a prior history of Type I hypersensitivity reactions are significant predictors of irAEs in patients receiving immune checkpoint inhibitors.
- These findings can aid clinicians in identifying high-risk individuals and implementing tailored monitoring or prophylactic strategies.
- Further prospective studies are warranted to validate these risk factors and explore potential interventions.
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