Steroid Premedication Impact on Efficacy and Cutaneous Toxicity of Enfortumab Vedotin for Advanced Urothelial Carcinoma.

Abstract

Background/aim: The impact of steroid premedication on the efficacy and cutaneous toxicity of enfortumab vedotin (EV) in advanced urothelial carcinoma (UC) is unclear.

Patients and methods: We retrospectively analyzed consecutive patients with advanced UC who received EV after the failure of platinum-based chemotherapy and immune checkpoint inhibitors from December 2021 to November 2024.

Results: Twenty-eight patients (male, n=16; median age, 71 years) were enrolled. Dexamethasone 6.6 mg was administered intravenously prior to EV in six (21.4%) patients. There were no differences in the overall response and disease control rates between patients with and without steroid premedication (p=0.653 and p>0.99, respectively). The progression-free survival was not significantly associated with or without steroid premedication (not estimable vs. 4.3 months, p=0.501). There were no marked differences in the incidence of all grades of EV-related cutaneous adverse events (AEs) between patients with and without steroid premedication (33.3% vs. 45.5%, p=0.673). There was no significant difference in the incidence of grade ≥3 EV-related cutaneous AEs between the patients with and without steroid premedication (16.7% vs. 36.4%, p=0.630). Multivariate analysis revealed that a performance status ≥2 was an independent prognostic factor for progression-free survival (hazard ratio=4.653, 95% confidence interval=1.263-17.140, p=0.021), and steroid premedication was not (p =0.869).

Conclusion: In EV treatment, steroid premedication did not affect clinical outcomes. The incidence and severity of EV-related cutaneous toxicity tended to improve in patients who received steroid premedication, although no significant differences were observed.