Efficacy and safety of routine corticosteroid premedication in enfortumab vedotin therapy for advanced urothelial carcinoma.

Abstract

Objective: This study aims to evaluate the efficacy and safety of routine corticosteroid premedication with dexamethasone for preventing chemotherapy-induced nausea and vomiting (CINV) in patients receiving enfortumab vedotin (EV) for previously treated advanced urothelial carcinoma (UC). Furthermore, we assessed the impact of this strategy on treatment continuity and the incidence of dermatologic toxicities.

Methods: We retrospectively analyzed 48 patients with unresectable or metastatic UC who received EV at our institution. All patients received 6.6 mg of intravenous dexamethasone prior to each EV infusion (1.25 mg/kg on Days 1, 8, and 15 of each 28-day cycle). Adverse events (AEs) were graded according to the National Cancer Institute Common Terminology Criteria for AEs version 5.0. Progression-free survival (PFS) and overall survival (OS) were evaluated using the Kaplan-Meier method, and factors influencing time to cutaneous toxicity onset were analyzed using Cox proportional hazards regression.

Results: The median PFS was 4.6 months (95% CI: 3.5-10.8), and the median OS was 14.8 months (95% CI: 7.4-20.0). Grade 1-2 nausea was observed in six patients (14.6%), with no Grade ≥ 3 nausea reported. Dermatologic toxicity occurred in 13 patients (31.7%), all Grade 1-2, and none required systemic corticosteroid therapy. Patients with normal serum albumin levels experienced significantly earlier cutaneous toxicity onset compared with those with abnormal levels (p = 0.015). Treatment continuity was largely maintained, with minimal severe AEs leading to discontinuation. However, the study's single-center, retrospective design and small sample size may limit the generalizability of these findings, warranting further prospective validation.

Conclusion: Routine dexamethasone premedication in patients receiving EV was feasible and associated with a low incidence of severe nausea and cutaneous toxicity. While these findings suggest a potential role for corticosteroids in CINV control and cutaneous toxicity mitigation, the retrospective design and absence of a control group preclude definitive conclusions. Further prospective studies are needed to clarify the impact of corticosteroid premedication in this setting.