EVOLUTE: Enfortumab Vedotin in OLder patients with locally advanced/metastatic UroThElial carcinoma.

Authors

Ilgın Akbıyık, Mathilde Cabart, Arnaud Pagès, Leticia Aptecar, Mathilde Cancel, Helen Boyle, Théophile Bertail, Loïc Mourey, Cedric Pobel, Yohann Loriot, Natacha Naoun, Maxime Frélaut

Published in

Clinical genitourinary cancer. Pages 102660. Sep 02, 2026. Epub Sep 02, 2026.

Abstract

Enfortumab vedotin (EV) has been a standard-of-care treatment for advanced/metastatic urothelial carcinoma (a/mUC). However, real-world data regarding its safety and efficacy in older patients remain limited. This study evaluated EV outcomes in a real-world setting, focusing on age-related toxicity.
We conducted a multicenter, retrospective cohort study including 99 patients with a/mUC treated with EV monotherapy. Patients were classified by age (< 70 vs. ≥ 70 years). Grade ≥ 3 toxicity, treatment modifications, and survival were evaluated. Multivariable logistic regression was performed to identify risk factors for grade ≥ 3 toxicity.
In the overall cohort, 33.3% experienced grade ≥ 3 toxicity. Multivariable analysis identified age ≥ 70 years as the only independent predictor for severe toxicity (Odds Ratio: 2.63, 95% Confidence Interval: 1.05-6.58; P = .039). Older patients had significantly higher rates of treatment discontinuation due to toxicity (34.6% vs. 4.3%; P < .001). Despite increased toxicity, patients aged ≥ 70 demonstrated numerically longer median PFS (6.3 vs. 3.1 months; P = .173) and OS (11.6 vs. 10.2 months; P = .830) compared to younger patients. Twelve patients receiving an upfront reduced dose (< 1.25 mg/kg) experienced no grade ≥ 3 toxicities while maintaining comparable survival outcomes to standard dosing.
EV demonstrates comparable efficacy in older patients, but age ≥ 70 years is a significant predictor of severe toxicity, and close monitoring is warranted. Upfront dose reduction is a promising strategy to reduce severe toxicity without compromising efficacy and requires prospective evaluation in patients with a high comorbidity burden or reduced performance status.

PMID:
42786039
Bibliographic data and abstract were imported from PubMed on 25 Sep 2026.

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