International journal of urology : official journal of the Japanese Urological Association · 2026
Efficacy and Safety of Enfortumab Vedotin by Trial Eligibility in Advanced Urothelial Carcinoma: A Multicenter Real-World Study.
СтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Wakita Naoto, Hara Takuto, Tobe Taisuke, Ueki Hideto, Suzuki Kotaro, Terakawa Tomoaki, Teishima Jun, Miyake Hideaki
Аннотация
OBJECTIVES: Enfortumab vedotin (EV) has shown survival benefits in advanced urothelial carcinoma (UC). However, patients with severe renal impairment, poor performance status, or anemia were excluded from pivotal trials. Evidence regarding real-world outcomes of EV in trial-ineligible populations remains limited.
METHODS: We retrospectively investigated 180 patients with advanced UC treated with EV between December 2021 and December 2024 at Kobe University Hospital or affiliated institutions. Patients were classified as trial-eligible or trial-ineligible using modified EV-301 eligibility criteria based on three factors: estimated glomerular filtration rate < 30 mL/min/1.73 m2, Eastern Cooperative Oncology Group performance status ≥ 2, and hemoglobin < 9 g/dL. Progression-free survival (PFS), overall survival (OS), objective response rate (ORR), and adverse events were evaluated.
RESULTS: The median age was 73 years, and 73.3% of the patients were male. Eighty-two patients (45.6%) were trial-ineligible. Median PFS (8.0 vs. 5.0 months, p = 0.005) and OS (17.9 vs. 10.5 months, p = 0.001) were significantly longer in trial-eligible patients. ORR was also higher in the trial-eligible group (55.1% vs. 31.7%, p = 0.003). The incidence of all-grade and grade ≥ 3 adverse events was comparable. Subgroup analyses demonstrated significantly poorer PFS and OS in patients with Eastern Cooperative Oncology Group performance status ≥ 2 or hemoglobin < 9 g/dL. Outcomes did not differ according to renal function.
CONCLUSIONS: Clinical outcomes following EV were poorer in trial-ineligible patients than in trial-eligible patients, while safety was comparable between the groups. Poor performance status and anemia were associated with worse survival outcomes, whereas severe renal impairment was not significantly associated with survival outcomes.
METHODS: We retrospectively investigated 180 patients with advanced UC treated with EV between December 2021 and December 2024 at Kobe University Hospital or affiliated institutions. Patients were classified as trial-eligible or trial-ineligible using modified EV-301 eligibility criteria based on three factors: estimated glomerular filtration rate < 30 mL/min/1.73 m2, Eastern Cooperative Oncology Group performance status ≥ 2, and hemoglobin < 9 g/dL. Progression-free survival (PFS), overall survival (OS), objective response rate (ORR), and adverse events were evaluated.
RESULTS: The median age was 73 years, and 73.3% of the patients were male. Eighty-two patients (45.6%) were trial-ineligible. Median PFS (8.0 vs. 5.0 months, p = 0.005) and OS (17.9 vs. 10.5 months, p = 0.001) were significantly longer in trial-eligible patients. ORR was also higher in the trial-eligible group (55.1% vs. 31.7%, p = 0.003). The incidence of all-grade and grade ≥ 3 adverse events was comparable. Subgroup analyses demonstrated significantly poorer PFS and OS in patients with Eastern Cooperative Oncology Group performance status ≥ 2 or hemoglobin < 9 g/dL. Outcomes did not differ according to renal function.
CONCLUSIONS: Clinical outcomes following EV were poorer in trial-ineligible patients than in trial-eligible patients, while safety was comparable between the groups. Poor performance status and anemia were associated with worse survival outcomes, whereas severe renal impairment was not significantly associated with survival outcomes.