Skin toxicity and effectiveness of first-line enfortumab vedotin plus pembrolizumab for urothelial carcinoma: a prospective multicenter real-world study in Japan.

@article{tamura2026skin,
  title = {{Skin toxicity and effectiveness of first-line enfortumab vedotin plus pembrolizumab for urothelial carcinoma: a prospective multicenter real-world study in Japan.}},
  author = {K Tamura and T Tsujino and R Taoka and K Kobayashi and M Miyake and K Ogawa and Y Sasaki and S Tatarano and S Katayama and M Kato and H Fukuhara and Y Abe and Y Oda and R Minato and R Shigehisa and R Maenosono and M Sugimoto and K Shiraishi and K Fujimoto and K Wada and J Furukawa and H Enokida and M Araki and J Uchida and K Inoue and T Inamoto and West Japan Uro-oncology Collaboration Group},
  journal = {ESMO real world data and digital oncology},
  year = {2026},
  month = oct,
  doi = {10.1016/j.esmorw.2026.100804},
  url = {https://europepmc.org/article/MED/42927021},
  note = {CC BY},
}

TY  - JOUR
TI  - Skin toxicity and effectiveness of first-line enfortumab vedotin plus pembrolizumab for urothelial carcinoma: a prospective multicenter real-world study in Japan.
AU  - K Tamura
AU  - T Tsujino
AU  - R Taoka
AU  - K Kobayashi
AU  - M Miyake
AU  - K Ogawa
AU  - Y Sasaki
AU  - S Tatarano
AU  - S Katayama
AU  - M Kato
AU  - H Fukuhara
AU  - Y Abe
AU  - Y Oda
AU  - R Minato
AU  - R Shigehisa
AU  - R Maenosono
AU  - M Sugimoto
AU  - K Shiraishi
AU  - K Fujimoto
AU  - K Wada
AU  - J Furukawa
AU  - H Enokida
AU  - M Araki
AU  - J Uchida
AU  - K Inoue
AU  - T Inamoto
AU  - West Japan Uro-oncology Collaboration Group
PY  - 2026
DA  - 2026/10/17
JO  - ESMO real world data and digital oncology
DO  - 10.1016/j.esmorw.2026.100804
UR  - https://europepmc.org/article/MED/42927021
AB  - Background  Skin toxicity is a common adverse event associated with enfortumab vedotin plus pembrolizumab (EVP) but its association with treatment outcomes remains unclear. We aimed to evaluate this association in patients with locally advanced or metastatic urothelial carcinoma (la/mUC).Patients and methods  This prospective multicenter observational study conducted in Japan enrolled patients receiving first-line EVP. Skin toxicity incidence, onset, and management were evaluated. Objective response rates (ORRs) were compared according to the development of skin toxicity within 42 days. Progression-free survival (PFS) was assessed using a prespecified 42-day landmark analysis and a time-dependent Cox model to account for immortal time bias.Results  Among 163 assessable patients, 94 (57.7%) developed skin toxicity at a median of 13 days, of whom 81 (86.2%) recovered. Patients with skin toxicity within 42 days had a higher ORR than those without (70.1% versus 44.2%, P < 0.001). In the landmark cohort (n = 144), skin toxicity was associated with longer PFS [hazard ratio (HR) 0.43, 95% confidence interval (CI) 0.22-0.84, log-rank P = 0.011]. In multivariable time-dependent Cox analysis, skin toxicity remained independently associated with longer PFS (HR 0.44, 95% CI 0.23-0.83, P = 0.011).Conclusion  Skin toxicity associated with first-line EVP was frequent, occurred early, and was generally manageable. Its development was associated with a higher ORR and its association with longer PFS persisted after accounting for immortal time bias. Skin toxicity may serve as a potential on-treatment prognostic indicator of favorable outcomes, although further validation is warranted.
SN  - 2949-8201
ER  -