Therapeutic advances in urology · 2026
Real-world use of enfortumab vedotin in metastatic urothelial carcinoma: efficacy, safety, and risk stratification.
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Catalano Martina, Bartoli Sara, Salfi Alessia, Bonalda Mirko, Della Seta Lorenzo, Paulet Alexandra, Bloise Francesco, Paolieri Federico, Galli Luca, Sisani Michele, Doni Laura, Perrella Armando, Antonuzzo Lorenzo, Roviello Giandomenico
Аннотация
BACKGROUND: Enfortumab vedotin (EV), an antibody-drug conjugate targeting Nectin-4, has demonstrated efficacy in advanced urothelial carcinoma (UC) following platinum-based chemotherapy and immune checkpoint inhibitor (ICI) therapy. However, real-world evidence on its effectiveness and safety remains limited.
METHODS: We conducted a multicenter retrospective study across Italian oncology centers to evaluate EV in patients with metastatic UC (mUC) who had progressed after prior platinum-based chemotherapy and ICI. The primary endpoints were progression-free survival (PFS) and overall survival (OS). Secondary endpoints included objective response rate (ORR), disease control rate (DCR), and safety. We also assessed prognostic factors, including a composite index (HERO score) based on baseline hemoglobin and neutrophil-to-lymphocyte ratio (NLR).
RESULTS: Fifty-three patients were included (median age 72 years; 41.5% ⩾75 years). The ORR was 34.0% (all partial responses), with a DCR of 58.5%. Median PFS and OS were 6.1 and 9.7 months, respectively. Multivariate analysis identified NLR ⩾ 4 and lung metastases as independent predictors of inferior PFS, while NLR ⩾ 4 remained independently associated with worse OS. Dose reductions and peripheral neuropathy were associated with improved outcomes. The HERO score significantly stratified patients by PFS and OS (p = 0.017 and p < 0.001, respectively). EV was generally well tolerated, with most adverse events being low-grade.
CONCLUSION: In this real-world cohort, EV confirmed its efficacy and manageable safety profile in mUC. The HERO score may provide a simple tool for risk stratification in clinical practice, though prospective validation is needed.
METHODS: We conducted a multicenter retrospective study across Italian oncology centers to evaluate EV in patients with metastatic UC (mUC) who had progressed after prior platinum-based chemotherapy and ICI. The primary endpoints were progression-free survival (PFS) and overall survival (OS). Secondary endpoints included objective response rate (ORR), disease control rate (DCR), and safety. We also assessed prognostic factors, including a composite index (HERO score) based on baseline hemoglobin and neutrophil-to-lymphocyte ratio (NLR).
RESULTS: Fifty-three patients were included (median age 72 years; 41.5% ⩾75 years). The ORR was 34.0% (all partial responses), with a DCR of 58.5%. Median PFS and OS were 6.1 and 9.7 months, respectively. Multivariate analysis identified NLR ⩾ 4 and lung metastases as independent predictors of inferior PFS, while NLR ⩾ 4 remained independently associated with worse OS. Dose reductions and peripheral neuropathy were associated with improved outcomes. The HERO score significantly stratified patients by PFS and OS (p = 0.017 and p < 0.001, respectively). EV was generally well tolerated, with most adverse events being low-grade.
CONCLUSION: In this real-world cohort, EV confirmed its efficacy and manageable safety profile in mUC. The HERO score may provide a simple tool for risk stratification in clinical practice, though prospective validation is needed.