Medizinische Universität Graz - Research portal
Selected Publication:
SHR Neuro Cancer Cardio Lipid Metab Microb
Niedersuess-Beke, D; Mayrhofer, K; Krauter, J; Schnabel, S; Gampenrieder, SP; Miechowiecki, J; Kiesl, D; Luger, F; Pfuner, J; Wiesinger, C; Vallet, S; Andalibi, H; Vais, D; Banner, A; Stoiber, F; Spielgelberg, J; Barth, D; Bauernhofer, T; Aufderklamm, S; Weibrecht, S; Mühlmann, J; Mayer, M; Hilbe, W; Boulmé, F; Klinglmair, G; Heintel, D; Shariat, SF; Pichler, M; Pichler, R.
Real-world Evidence for Enfortumab Vedotin in Patients with Metastatic Urothelial Cancer: An Austrian Multicentre Study.
Clin Genitourin Cancer. 2025; 23(1):102278
Doi: 10.1016/j.clgc.2024.102278
Web of Science
PubMed
FullText
FullText_MUG
- Co-authors Med Uni Graz
- Barth Dominik Andreas
- Bauernhofer Thomas
- Pichler Martin
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- Abstract:
- AIM: Enfortumab vedotin (EV) represents a novel treatment for patients with locally advanced or metastatic urothelial carcinoma (la/mUC) refractory to platinum-based chemotherapy and PD(L)-1 containing therapies. Real-world data are crucial for informing health policy decisions and validating clinical trial findings. METHODS: We conducted a multicentre, retrospective real-world analysis comprising 128 patients with la/mUC from 16 Austrian centres treated with EV from April 2022 to April 2024, presenting the second largest real-world cohort to date. Data were analysed for efficacy and safety parameters. RESULTS: The median age was 69 years, the objective response rate 31% and the disease control rate 47%, with 9% of patients exhibiting a complete remission, 23% a partial remission and 16% a stable disease. After a median follow-up of 6.2 months, the median progression-free survival (mPFS) and the median overall survival (mOS) reached 4.8 and 10.75 months, respectively. Patients with good ECOG PS 0-1, metachronous metastatic disease and absence of liver metastases had significantly better OS. No difference in efficacy was observed in patients who received a reduced dose EV after experiencing adverse events. The safety profile was acceptable, showing grade ≥3 TRAEs in 25.8% of patients. CONCLUSION: In our real-world population, the administration of EV was feasible and effective, with no new safety signals. Lower efficacy data compared to previous trials might be explained by the use in later therapy lines and in patients with poorer ECOG PS. Our data corroborate the efficacy and safety of EV monotherapy in later lines.
- Find related publications in this database (using NLM MeSH Indexing)
- Humans - administration & dosage
- Male - administration & dosage
- Aged - administration & dosage
- Female - administration & dosage
- Retrospective Studies - administration & dosage
- Austria - administration & dosage
- Middle Aged - administration & dosage
- Aged, 80 and over - administration & dosage
- Antibodies, Monoclonal - administration & dosage, therapeutic use, adverse effects
- Carcinoma, Transitional Cell - drug therapy, secondary
- Urologic Neoplasms - drug therapy, pathology
- Treatment Outcome - administration & dosage
- Progression-Free Survival - administration & dosage
- Urinary Bladder Neoplasms - drug therapy, pathology
- Find related publications in this database (Keywords)
- Metastatic urothelial carcinoma
- Registry
- Real-world data
- Toxicity