Clinical genitourinary cancer · 2024
Real-world Evidence for Enfortumab Vedotin in Patients with Metastatic Urothelial Cancer: An Austrian Multicentre Study.
СтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Niedersuess-Beke Dora, Mayrhofer Karl, Krauter Johanna, Schnabel Susanne, Gampenrieder Simon Peter, Miechowiecki Jan, Kiesl David, Luger Ferdinand, Pfuner Jakob, Wiesinger Clemens, Vallet Sonia, Andalibi Haleh, Vais Dominik, Banner Andreas, Stoiber Franz, Spielgelberg Jasmin, Barth Dominik, Bauernhofer Thomas, Aufderklamm Stefan, Weibrecht Sabine, Mühlmann Josef, Mayer Michael, Hilbe Wolfgang, Boulmé Florence, Klinglmair Gerald, Heintel Daniel, Shariat Shahrokh F, Pichler Martin, Pichler Renate
Аннотация
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.
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.