Impact of Skin Adverse Events on Prognosis in Patients With Locally Advanced or Metastatic Urothelial Carcinoma Treated With Enfortumab Vedotin: A Real-World Multicenter Study.

Abstract

Objective: We aimed to investigate the impact of skin adverse events (AEs) of enfortumab vedotin (EV) on prognosis in patients with locally advanced or metastatic urothelial carcinoma in real-world practice.

Methods: This study analyzed data from 115 patients with locally advanced or metastatic urothelial carcinoma. We evaluated the association between EV dose and skin AEs in these patients. The impact of skin AEs on progression-free survival (PFS) and overall survival (OS) was assessed using Kaplan-Meier curves and Cox regression analysis.

Results: The median PFS and OS were 8.1 and 14.5 months, respectively. EV dose reduction was observed in 68 (59.1%) patients. An estimated dose amount in the first, second, and seventh cycles was 95%, 85%, and 81%, respectively. We observed skin AEs in 69 (60%) cases, and they were observed within 1 month in 53 (76.8%) of cases. Patients with skin AEs had significantly longer PFS and OS compared to those without skin AEs. Multivariable Cox regression analysis showed a significant association of skin AEs with prolonged PFS and OS.

Conclusions: Skin AEs were significantly associated with prolonged prognosis compared to those without skin AEs, although EV dose reduction was required in 59.1% of patients. Careful dose adjustment of EV may be crucial for long-term use and optimizing oncological outcomes.