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Life sciences · Journal article
Frontiers in Pharmacology · October 12, 2026
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Objective Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) are standard targeted therapies for EGFR-mutant non-small cell lung cancer (NSCLC), but clinically documented EGFR-TKI-associated colitis remains incompletely characterized. We aimed to describe its clinical, radiographic, endoscopic, histopathologic, management, and exploratory survival features. Methods We conducted a single-center retrospective case-control analysis nested within an institutional cohort of 3,285 patients with NSCLC treated with EGFR-TKIs between January 2018 and July 2025. The analysis included 43 patients with documented radiographic and/or endoscopic colitis and 223 selected asymptomatic controls. Clinical, imaging, colonoscopic, histopathologic, treatment, and survival data were reviewed. Ever-smoking was examined in an exploratory univariable logistic analysis. Drug-specific EGFR-TKI odds were not estimated because a common time-aligned exposure definition for cases and controls could not be reconstructed, and overall survival was examined exploratorily. Results Clinically documented EGFR-TKI-associated colitis occurred in 43/3,285 treated patients (1.3%). Ever-smoking was more frequent among cases than selected controls (39.5% vs. 20.2%; univariable odds ratio = 2.586, 95% confidence interval: 1.293–5.173, P = 0.007). Drug-specific odds were not estimated because a common time-aligned exposure definition could not be reconstructed. Median symptom onset was 3 months. Diarrhea occurred in 40/43 patients (93.0%); three patients had grade 0 diarrhea. Among 39 patients undergoing colonoscopy, 14 had normal-appearing mucosa; 11 of these patients underwent biopsy and showed histologic inflammation. Of 35 classifiable biopsies, 10 (28.6%) showed a microscopic pattern, 14 (40.0%) an inflammatory/IBD-like pattern, and 11 (31.4%) an ischemic-like pattern. In exploratory survival analysis, no statistically significant association between documented colitis and overall survival was detected (log-rank P = 0.538; adjusted HR = 1.184, 95% CI: 0.782–1.793, P = 0.426). Conclusion Clinically documented EGFR-TKI-associated colitis showed heterogeneous radiographic, endoscopic, and histopathologic patterns. Normal-appearing mucosa did not exclude histologic inflammation in biopsied patients. The 1.3% value represents documented cases in this institutional cohort rather than population incidence. The recorded smoking difference, severity-stratified findings, treatment outcomes, and survival estimates should be interpreted as exploratory; no drug-specific colitis association is inferred.