What does this research mean for the field?

Immunotherapy is associated with a significantly higher risk of gastrointestinal adverse events, including colitis and elevated liver enzymes, compared to non-immunotherapy systemic treatments in a real-world cancer population, though most events are low-to-moderate grade and manageable. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

What question did this study set out to answer?

This study aims to compare the risk of gastrointestinal adverse events in patients receiving immunotherapy versus those on non-immunotherapy systemic therapies.

May 30, 2026

Risk of gastrointestinal (GI) immune-related adverse events (irAEs): Real-world experience.

Key Points

This study aims to compare the risk of gastrointestinal adverse events in patients receiving immunotherapy versus those on non-immunotherapy systemic therapies.
Conducted a retrospective cohort study of 5,556 adult cancer patients at Cleveland Clinic Ohio from 2010 to 2022.
Compared the occurrence of gastrointestinal adverse events in patients treated with immunotherapy versus non-immunotherapy regimens.
Utilized Poisson regression and time-dependent Cox models for data analysis.
430 gastrointestinal adverse events and 268 entero-colonic composite events were reported with a median follow-up of 14 months.
Immunotherapy was correlated with higher incidence rates of gastrointestinal adverse events (0.50 vs 0.27 per 100 person-years, P < 0.05).
Among colitis cases, 48% were grade 2, with a notable percentage requiring treatment or discontinuation.

Abstract

e23410 Background: Immune checkpoint inhibitors (ICI) improve survival across solid tumors but can cause gastrointestinal (GI) irAEs. Real-world comparative data remains limited, particularly for composite GI outcomes. We compared the risk of GI AEs in patients receiving immunotherapy (IT) versus non-IT systemic therapy. Methods: We conducted a retrospective cohort study of 5,556 adult cancer patients treated at Cleveland Clinic Ohio between 2010–2022. Included cancers were advanced-stages bladder, endometrial, esophageal, gastric, head 99.9% of IT was ICI. Follow-up began at systemic therapy start 38% were female P = 0.01). Among colitis cases, 48% were grade 2, 25% grade 3 89% required treatment, 46% received immunomodulators P = 0.04) P = 0.04), with no change in ALT, AST, alkaline phosphatase, total bilirubin, or APTT. Baseline values strongly predicted longitudinal changes, & alkaline phosphatase, ALT, total bilirubin & APTT increased over time (P < 0.05). Conclusions: IT was frequently associated with GI AEs, reaching 15% at 4 years, though most were low-to-moderate grade & manageable. IT was associated with selective laboratory changes, while baseline liver values remained the strongest predictors. Lower esophagitis incidence may reflect reduced radiation exposure. Hepatic synthetic markers improved with IT. IT group (n=1,288) Non-IT group (n=4,268) Colitis: absolute number 29 28 Colitis: 2-year CIR / TD-HR TD-HR 2.5% (1.5%, 3.5%) / HR 5.2 (3.0, 9.0) 0.6% (0.4%, 0.9%) / Ref Diarrhea: absolute number 45 157 Diarrhea: CIR / TD-HR 4.3% (3.0%, 5.7%) / HR 1.4 (1.1, 1.9) 4.0% (3.3%, 4.7%) / Ref Elevated liver enzymes: absolute number 41 67 Elevated liver enzymes: CIR / TD-HR 3.8% (2.6%, 5.1%)/ HR 3.2 (2.2, 4.7) 1.7% (1.3%, 2.2%)/ Ref

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