ArticleInternational journal of clinical oncology2026
Timing-dependent skin toxicity phenotypes during enfortumab vedotin plus pembrolizumab therapy for advanced urothelial carcinoma.
Article in International journal of clinical oncology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundEnfortumab vedotin plus pembrolizumab (EV/Pem) has improved the survival of patients with advanced urothelial carcinoma; however, many patients suffer treatment-related adverse events, particularly skin toxicity. This study aimed to clarify the clinical impact of skin-toxicity timing on treatment outcomes.
methodsWe retrospectively analyzed patients with advanced urothelial carcinoma treated with EV/Pem. Patients were categorized into three groups according to skin-toxicity timing: no rash, early-onset rash (< 1 month), and late-onset rash (≥ 1 month). Baseline clinical and laboratory characteristics were compared among groups and incorporated into multivariable Cox proportional hazards analyses. Kaplan-Meier analyses with pairwise log-rank tests were performed to evaluate progression-free survival (PFS) and overall survival (OS). The 1-month cutoff was selected for clinical interpretability.
resultsThe three-group analysis included 210 patients: no rash (n = 87), early-onset rash (n = 84), and late-onset rash (n = 39). Late-onset rash was associated with significantly prolonged PFS and OS in conventional analyses. In multivariable analysis, late-onset rash was significantly associated with prolonged PFS (HR 0.34, 95% CI 0.15-0.74, p = 0.007) and OS (HR 0.25, 95% CI 0.07-0.81, p = 0.02). Because late-onset rash could only be assigned after continued observation, these associations should be interpreted as exploratory and potentially affected by immortal time bias. In the 3-month landmark analysis, PFS remained significantly longer in the late-onset than early-onset rash group, whereas OS did not differ significantly.
conclusionsSkin toxicity during EV/Pem therapy appears to have timing-dependent prognostic implications. Late-onset rash showed favorable outcomes in conventional analyses, but these findings should be considered hypothesis-generating.
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