Journal Article Multicenter Study Ppublish
PubMed: 40252634 DOI: 10.1016/j.ejca.2025.115427
Association between drug-related cutaneous adverse events and survival outcomes in patients treated with enfortumab vedotin.
Eur J Cancer 222:115427
Authors: Samy Belkaïd, Emmanuel Ribereau-Gayon, Sylvie Chabaud, Julien Anriot, Thibald Chalas, Aude Fléchon, Helen Boyle, Armelle Vinceneux, Frédéric Bérard, Benoît You, Gilles Freyer, Sophie Darnis, Sophie Tartas, Mona Amini-Adle
Affiliations
- Dermatologie, Centre Léon Bérard, Lyon, France; Dermatologie, Hôpital Lyon Sud, Hospices Civils de Lyon, Oullins-Pierre-Bénite, France; Université Claude Bernard Lyon 1, Villeurbanne, France.
- Dermatologie, Hôpital Lyon Sud, Hospices Civils de Lyon, Oullins-Pierre-Bénite, France; Université Claude Bernard Lyon 1, Villeurbanne, France.
- Direction de la Recherche Clinique et de l'Innovation, Centre Léon Bérard, Lyon, France.
- Dermatologie, Centre Léon Bérard, Lyon, France; Université Claude Bernard Lyon 1, Villeurbanne, France.
- Oncologie médicale, Centre Léon Bérard, Lyon, France.
- Dermatologie, Centre Léon Bérard, Lyon, France; Université Claude Bernard Lyon 1, Villeurbanne, France; Immunologie clinique et allergologie, Hôpital Lyon Sud, Hospices Civils de Lyon, Oullins-Pierre-Bénite, France.
- Université Claude Bernard Lyon 1, Villeurbanne, France; Oncologie médicale, Hôpital Lyon Sud, EPSILYON-CITOHL, Hospices Civils de Lyon (IC-HCL), Oullins-Pierre-Bénite, France.
- Oncologie médicale, Hôpital Lyon Sud, EPSILYON-CITOHL, Hospices Civils de Lyon (IC-HCL), Oullins-Pierre-Bénite, France.
- Dermatologie, Centre Léon Bérard, Lyon, France.
Abstract
AIM OF THE STUDY
The antibody-drug conjugate enfortumab vedotin (EV) received approval in patients with metastatic urothelial carcinoma (mUC). EV-related cutaneous toxicities are frequently reported, whether EV-related AEs association with survival may exist is still unknown. We aim to report the association between cutaneous toxicities and survival in patients receiving EV.
METHODS
This retrospective study enrolled patients treated with monotherapy EV from two oncology centers, followed up for at least 3-months, and data collection demographics, treatments, toxicities, and outcomes. The primary endpoint was progression-free survival (PFS) in patients experiencing cutaneous toxicities or not. Overall survival (OS) was the secondary endpoint.
RESULTS
Data from 63 patients treated with EV from July 19, 2019, to March 12, 2024, were collected. Among them, the 18 (28.6 %) patients experiencing any-grade cutaneous toxicities during EV treatment showed significantly longer median PFS (mPFS: 9.2 vs. 4.7 months, hazard ratio [HR] 0.35; p = 0.0041) and OS (mOS: not reached vs. 8.4 months, HR 0.38; p = 0.0253). The multivariate analysis showed a significant association of cutaneous toxicities with improved PFS (HR 0.40, p = 0.0319), and did not demonstrate significant association with OS even if tendency was kept (HR 0.41, p = 0.067).
CONCLUSION
These results support that patients experiencing any-grade cutaneous toxicity (skin rash) had a prolonged PFS. With the recent expansion of combined treatment using EV plus pembrolizumab in first-line in mUC patients, cutaneous toxicities need to be carefully monitored and optimized dedicated management provided, considering that cutaneous toxicity may be predictive of patient outcome.
MeSH
Pharmaceutical Preparations, Exanthema, Drug-Related Side Effects And Adverse Reactions, Therapeutics