Cutaneous and Renal Toxicities of Enfortumab Vedotin for Advanced Urothelial Carcinoma: The UROKYU Study

Anticancer Res. 2024 Jul;44(7):3025-3032. doi: 10.21873/anticanres.17115.

Abstract

Background/aim: The clinical outcomes associated with cutaneous toxicity and changes in the renal function of patients receiving enfortumab vedotin (EV) for advanced urothelial carcinoma (UC) is unclear.

Patients and methods: We retrospectively analyzed the relationship between clinical outcomes and EV-related cutaneous toxicity, and the influence on the renal function in 58 patients with advanced UC who received EV after the failure of platinum-based chemotherapy and immune checkpoint inhibitors from December 2021 to July 2023.

Results: There were no differences in the overall response and disease control rates between patients with any grade of EV-related cutaneous toxicity and without (p=0.605 and p>0.99, respectively) nor of grade ≥3 (p>0.99 and p=0.173, respectively). Progression-free survival was not significantly associated with EV-related cutaneous toxicity of any grade (5.4 vs. 5.6 months, p=0.557) nor of grade ≥3 (2.7 vs. 5.6 months, p=0.053). Overall survival was not significantly associated with EV-related cutaneous toxicity of any grade (11.8 vs. 8.9 months, p=0.389), nor of grade ≥3 (4.6 vs. 11.4 months, p=0.168). The incidence of EV-related cutaneous toxicity of any grade was significantly higher in patients with any grade of ICI-related cutaneous toxicity (88.9% vs. 36.7%, p=0.008). There was no significant difference in the serum creatinine levels after EV treatment (p=0.211). Divided into two groups according to their renal function, using a serum creatinine cut-off of 2 mg/dl, there were no significant changes after EV treatment in either group (p=0.187 and p=0.938).

Conclusion: EV-related cutaneous toxicity did not affect clinical outcomes, although it occurred in patients who experienced immune checkpoint inhibitor-related cutaneous toxicity. EV did not affect renal function.

Keywords: Urothelial carcinoma; cutaneous toxicity; enfortumab vedotin; renal function toxicity.

MeSH terms

  • Aged
  • Aged, 80 and over
  • Antibodies, Monoclonal* / adverse effects
  • Antibodies, Monoclonal* / therapeutic use
  • Antineoplastic Agents, Immunological / adverse effects
  • Antineoplastic Agents, Immunological / therapeutic use
  • Carcinoma, Transitional Cell / drug therapy
  • Carcinoma, Transitional Cell / pathology
  • Female
  • Humans
  • Kidney / drug effects
  • Kidney / pathology
  • Kidney / physiopathology
  • Male
  • Middle Aged
  • Retrospective Studies
  • Urologic Neoplasms / drug therapy
  • Urologic Neoplasms / pathology

Substances

  • Antibodies, Monoclonal
  • enfortumab vedotin
  • Antineoplastic Agents, Immunological