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. 2025 Feb;30(2):267-276.
doi: 10.1007/s10147-024-02672-3. Epub 2024 Dec 16.

Treatment-related skin reactions in enfortumab vedotin as a surrogate marker of survival and treatment response

Jun Nagayama  1 , Satoshi Inoue  2 , Hiroki Sai  2   3 , Akira Hayakawa  4 , Yuri Yuguchi  5 , Tomohide Suzuki  6 , Hirotaka Matsui  7 , Takuma Yuba  8 , Koya Morishita  9 , Shusuke Akamatsu  2
Affiliations

Treatment-related skin reactions in enfortumab vedotin as a surrogate marker of survival and treatment response

Jun Nagayama et al. Int J Clin Oncol. 2025 Feb.

Abstract

Background: Treatment-related skin reactions (TRSRs) induced by enfortumab vedotin (EV) targeting nectin-4 are among the most common adverse events. However, their association with survival and treatment response is poorly understood.

Methods: We retrospectively identified patients who received EV from December 2021 to April 2023 at Nagoya University Hospital and its affiliated facilities and extracted clinical data from their medical records. We evaluated cancer-specific survival (CSS) and progression-free survival (PFS) as survival outcomes and overall response rate (ORR) and disease control rate (DCR) as treatment responses between patients with and without TRSRs.

Results: In total, 67 eligible patients were identified. Thirty-four patients experienced TRSRs, and the remaining 33 did not experience TRSRs. The median follow-up period was 8 months. Patients in the TRSRs group demonstrated significantly longer median CSS (15 vs. 8 months; p = 0.003) and median PFS (10 vs. 5 months; p < 0.001) than the non-TRSRs. Regarding treatment response, the patients in the TRSRs group showed a favorable, albeit nonsignificant, treatment response trend compared with those in the non-TRSRs group (ORR, 73.5% vs. 51.5%; p = 0.107; DCR, 91.2 % vs. 81.8%; p = 0.444).

Conclusions: Patients with TRSRs demonstrated more prolonged survival and superior treatment responses to EV treatment. The role of TRSR as a surrogate marker of EV's efficacy should be further explored in prospective and sufficiently powered studies.

Keywords: Adverse effects; Bladder cancer; Enfortumab vedotin; Skin rash; Urothelial carcinoma.

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Conflict of interest statement

Declarations. Conflict of interest: Shusuke Akamatsu received honoraria for lectures from Astellas. The remaining authors have declared no conflict of interest.

Figures

Fig. 1
Fig. 1
Enrolled patients’ inclusion criteria
Fig. 2
Fig. 2
Kaplan–Meier curves showing the comparison of CSS and PFS between patients with and without TRSRs
See this image and copyright information in PMC

References

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