ArticleJournal of experimental & clinical cancer research : CR2023
Patterns of toxicity burden for FDA-approved immune checkpoint inhibitors in the United States.
Article in Journal of experimental & clinical cancer research : CR, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 42 papers, 3 of them syntheses that pooled it.
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Who cites it
42 citing papers in PubMed, 3 syntheses or guidelines pooled it, 57 citations in OpenAlex.
- Avoidance of cardiac toxicity during the application of immune checkpoint inhibitors: a safety systematic review combining network meta-analysis and pharmacovigilance study.Frontiers in immunology · 2026Pooled it
- The association of PD-L1 expression status and the PD-1/PD-L1 inhibitor-related toxicity profile in non-small cell lung cancer.BMC cancer · 2025Pooled it
- miRNAs Related to Immune Checkpoint Inhibitor Response: A Systematic Review.International journal of molecular sciences · 2024Pooled it
- Rational design of a V-shaped DNA-targeted photosensitizer enables endogenous DNA damage-driven cGAS-STING activation and systemic antitumor immunity.Materials today. Bio · 2026Article
- Integration Analysis of Bayesian and Machine Learning for Heterogeneity, Biomarkers, and Optimal Combination Regimens of Pucotenlimab in Solid Tumors.Cancer medicine · 2026Article
- Endocrinologist-Led Management of Endocrine Immune-Related Adverse Events: Real-World Evidence Supporting the Japan Endocrine Society Guidelines.Cancer medicine · 2026Observational
- Cardiac adverse events associated with dual immune checkpoint inhibitors: a pharmacovigilance analysis from the FDA adverse event reporting system.European heart journal. Cardiovascular pharmacotherapy · 2026Article
- Immune-Related Adverse Events Associated with Immune Checkpoint Inhibitors: A Scoping Review.Pharmaceuticals (Basel, Switzerland) · 2026Review
- Oncolytic virus OH2 induces PD-L1 upregulation via NF-κB signaling and synergizes with anti-PD-L1 therapy in prostate cancer through a targeted extracellular vesicle delivery system.Journal for immunotherapy of cancer · 2026Article
- Circadian rhythm in immunotherapy and cellular therapy: impacts on the tumor microenvironment.Acta biochimica et biophysica Sinica · 2026Review
- Therapeutic mRNA vaccines for lung cancer: reshaping the tumor microenvironment to enhance anti-tumor immunity.Frontiers in immunology · 2026Review
- Integrative analysis of FAERS, network toxicology, and Mendelian randomization identifies potential targets in paclitaxel-associated systemic sclerosis.Frontiers in immunology · 2026Article
- Understanding immune checkpoint inhibitors-related myocarditis: Mechanisms and targeted therapeutic pathways.Theranostics · 2026Review
- The real-world safety profile of enfortumab vedotin with or without pembrolizumab: insights from a comparative analysis of FAERS.Frontiers in immunology · 2026Article
- Sex-specific reporting patterns and onset timing of immune-related adverse events associated with nivolumab and pembrolizumab: a dual-database pharmacovigilance analysis.Frontiers in immunology · 2026Article
- Dynamic changes in gut microbiota and metabolites in advanced lung cancer patients with immune-related adverse events.Frontiers in immunology · 2026Article
- Neurotoxicity of immune checkpoint inhibitors: a retrospective pharmacovigilance study using FAERS database.Frontiers in immunology · 2026Article
- Comparative Safety Analysis of Hydromorphone and Morphone Sulfate: Evidence from the 2004-2024 FAERS.Journal of pain research · 2026Article
- Article
- Evaluating Urinary Biomarkers for Early Detection of Kidney Damage in Immune Checkpoint Inhibitors-Treated Patients.American journal of nephrology · 2025Article
Corrections and comments
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Authors and funding
8 authors at 4 institutions in 1 country.
Funding
Abstract
backgroundImmune-related adverse events (irAEs) are a common phenomenon in cancer patients treated with immune checkpoint inhibitors (ICIs). Surprisingly, the toxicity burdens of these irAEs have not been illustrated clearly. In this study, we analyzed irAEs for seven FDA-approved ICIs in cancer treatment to show the pattern of toxicity burden among cancer patients.
methodsirAEs associated with seven FDA-approved ICIs, including three PD-1 inhibitors (cemiplimab, nivolumab and pembrolizumab), three PD-L1 inhibitors (atezolizumab, avelumab and durvalumab), and one CTLA-4 inhibitor (ipilimumab), were analyzed based on data from 149,303 reported cases (from January 1, 2015 to June 30, 2022) collected from the FDA Adverse Events Reporting System (FAERS) public dashboard. Proportions of serious irAEs and correlations with tumor type, age and sex were assessed via R package and GraphPad software.
resultsirAEs related to anti-PD-1 ICIs required less hospital care resources compared with anti-PD-L1 and anti-CTLA-4 ICIs. Patients treated with pembrolizumab had relatively fewer serious cases. Treatment with ICIs led to the highest probability of serious irAEs in patients with lung cancer. 'Respiratory, thoracic and mediastinal disorders' and 'gastrointestinal disorders' were the two most common groups of disorders caused by the seven ICIs studied. 'Cardiac disorders' was the main type of disorders caused by these ICIs in cancer patients aged 65-85, while 'reproductive system and breast disease' was the main type of disorder in cancer patients aged 18-64. 'Respiratory, thoracic, mediastinal diseases' and 'reproductive system and breast diseases' were the main types of disorders associated with treatment with these ICIs in male and female patients, respectively.
conclusionTissue and organ toxicities of ICIs are age and sex specific. There are risks of respiratory and urinary system toxicity in male patients and reproductive system toxicity in female patients treated with the ICIs studied. Future studies on the toxicity burden of ICIs should incorporate age and sex differences to better understand the relevance of ICI toxicity burden to human immune function to develop appropriate tumor immune and therapeutic intervention strategies.
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