TY - JOUR
T1 - Real-world Evidence for Enfortumab Vedotin in Patients with Metastatic Urothelial Cancer
T2 - An Austrian Multicentre Study
AU - Niedersuess-Beke, Dora
AU - Mayrhofer, Karl
AU - Krauter, Johanna
AU - Schnabel, Susanne
AU - Gampenrieder, Simon Peter
AU - Miechowiecki, Jan
AU - Kiesl, David
AU - Luger, Ferdinand
AU - Pfuner, Jakob
AU - Wiesinger, Clemens
AU - Vallet, Sonia
AU - Andalibi, Haleh
AU - Vais, Dominik
AU - Banner, Andreas
AU - Stoiber, Franz
AU - Spielgelberg, Jasmin
AU - Barth, Dominik
AU - Bauernhofer, Thomas
AU - Aufderklamm, Stefan
AU - Weibrecht, Sabine
AU - Mühlmann, Josef
AU - Mayer, Michael
AU - Hilbe, Wolfgang
AU - Boulmé, Florence
AU - Klinglmair, Gerald
AU - Heintel, Daniel
AU - Shariat, Shahrokh F
AU - Pichler, Martin
AU - Pichler, Renate
N1 - Publisher Copyright:
© 2024 The Authors
PY - 2024/11/22
Y1 - 2024/11/22
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85212179758&partnerID=8YFLogxK
U2 - 10.1016/j.clgc.2024.102278
DO - 10.1016/j.clgc.2024.102278
M3 - Journal article
C2 - 39672785
SN - 1558-7673
SP - 102278
JO - Clinical Genitourinary Cancer
JF - Clinical Genitourinary Cancer
M1 - 102278
ER -