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Asia-Pacific journal of clinical oncology · 2026

Efficacy and Safety of Two-Weekly Enfortumab Vedotin in Combination With Pembrolizumab for Advanced Urothelial Carcinoma.

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Nakagawa Ryunosuke, Izumi Kouji, Toshima Kazuki, Fujimura Rikushi, Yoshida Tsukasa, Inaba Takahiro, Aoyama Shuhei, Kamijima Taiki, Kano Hiroshi, Makino Tomoyuki, Naito Renato, Iwamoto Hiroaki, Yaegashi Hiroshi, Shigehara Kazuyoshi, Nohara Takahiro, Mizokami Atsushi

Аннотация

INTRODUCTION: Enfortumab vedotin (EV) plus pembrolizumab (PEM) is a standard first-line therapy for advanced urothelial carcinoma (UC), but EV-related toxicities frequently lead to treatment modification or discontinuation. This study evaluated the efficacy and safety of a two-weekly EV dosing schedule combined with PEM in real-world clinical practice.

METHODS: This retrospective observational study included treatment-naïve patients with metastatic UC who received two-weekly EV (1.25 mg/kg) plus PEM. Treatment response, survival outcomes, adverse events (AEs), and treatment modifications were assessed.

RESULTS: Twenty patients were included. The objective response rate was 75%, including complete responses in 10% of patients. Median progression-free survival and overall survival were not reached; 6-and 12-month progression-free survival rates were 74.4% and 68.2%, respectively, and 6-and 12-month overall survival rates were 89.7% and 84.1%. Any-grade AEs occurred in 85% of patients, and grade ≥ 3 AEs occurred in 35% of patients. The most common AEs were skin reaction, peripheral sensory neuropathy, and liver dysfunction. No grade ≥ 3 cutaneous toxicities or peripheral neuropathy were observed.

CONCLUSIONS: Two-weekly EV administration combined with PEM showed favorable antitumor activity with manageable toxicity in patients with advanced UC. This dose-modified regimen may represent a feasible treatment option in real-world settings, although prospective validation is warranted.

ИП Урсолов Владлен Сергеевич

ИНН 500118482352 · ОГРНИП 314500117700049

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