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Bladder and Urothelial Cancer Treatments · Journal article
Journal of Cancer Research and Clinical Oncology · August 11, 2026
Early or partial results. Treat as a signal, not a conclusion.
This exploratory retrospective cohort study in 108 UC patients treated with ICIs identified associations between low baseline tumor miRNA expression (miR-34c-5p, miR-493-5p) and increased irAE risk, with p-values of 0.037 and 0.027 respectively. The findings are preliminary and hypothesis-generating, requiring prospective validation before these miRNAs can be considered clinically useful biomarkers for irAE prediction.
Retrospective cohort study. 108 UC patients treated with ICI therapy (PD-1 and PD-L1 blockade); setting and detailed eligibility criteria not specified.. Intervention: Baseline tumor miRNA expression profiling via RT-qPCR. Compared with: Subsequent irAE development (pneumonitis, asthenia, hepatitis, anemia). n = 108.
irAE prevalence was approximately one-third of the cohort (irAE rate ~33%) Low miR-34c-5p baseline expression associated with pneumonitis risk (p = 0.037) Low miR-493-5p baseline expression associated with asthenia risk (p = 0.027)
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These findings are exploratory and should not yet guide clinical management. Clinicians should await prospective validation studies before considering tumor miRNA profiling for irAE risk stratification in UC patients.
Exploratory retrospective cohort study identifying associations between tumor miRNA expression and irAE risk, with modest sample size and statistical power requiring validation before clinical use.
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These findings are exploratory and should not yet guide clinical management. Clinicians should await prospective validation studies before considering tumor miRNA profiling for irAE risk stratification in UC patients.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
Immune checkpoint inhibitors (ICIs) have revolutionized advanced urothelial carcinoma (UC) treatment, yet efficacy is limited by immune-related adverse events (irAEs) necessitating treatment termination. Identifying biomarkers to predict irAE susceptibility is a critical unmet need for patient management. This exploratory study sought to identify tumor microRNA (miRNA) expression signatures associated with irAE risk in UC patients treated with ICIs. We analyzed a retrospective cohort of 108 UC patients treated with ICI therapy (PD-1 and PD-L1 blockade). Baseline tumor miRNA expression was quantified via RT-qPCR. Statistical analysis was performed to identify associations between baseline miRNA expression levels and the subsequent development of specific irAEs. The irAE prevalence was high, affecting approximately one-third of the cohort. Low baseline tumor expression of miR-34c-5p and miR-493-5p was significantly associated with an increased risk of developing pneumonitis ( p = 0.037) and asthenia ( p = 0.027). Furthermore, borderline associations were observed for miR-146a-5p (hepatitis), miR-222-3p (pneumonitis) and miR-641 (anemia), supporting their roles in regulating immune homeostasis. In this exploratory study, tumor miRNA expression profiles, particularly the low baseline expression of miR-34c-5p and miR-493-5p, suggest a possible relationship with higher risk of developing toxicity during ICI treatments. Although further studies are needed to validate the utility of tumor miRNAs expression as biomarkers of ICI-induced toxicity, these preliminary results remark their possible utility as biomarkers in the clinical management of adverse effects from ICI treatment in UC patients.
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