Japanese journal of clinical oncology · 2026
Short-term efficacy and safety of enfortumab vedotin plus pembrolizumab as a first-line treatment for advanced urothelial carcinoma regardless of cisplatin eligibility.
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Hayashi Takuji, Kawashima Atsunari, Yamamoto Yoshiyuki, Ishizuya Yu, Horitani Hiromu, Inoguchi Shunsuke, Horibe Yuki, Sassi Nesrine, Hayashi Yujiro, Ujike Takeshi, Nakano Kosuke, Miyake Osamu, Takayama Hitoshi, Yazawa Koji, Tsutsui Kenji, Kurahashi Yutaka, Nakata Wataru, Asakura Toshihisa, Murakawa Tetsuya, Okada Koichi, Nakayama Masashi, Kato Taigo, Hatano Koji, Nonomura Norio
Аннотация
OBJECTIVE: This study aimed to evaluate the short-term efficacy and safety of enfortumab vedotin plus pembrolizumab (EV + P) as a first-line systemic therapy for patients with advanced urothelial carcinoma (UC) in real-world practice, with a focus on cisplatin (CDDP) eligibility.
METHODS: Seventy-six patients who received EV + P treatment for advanced UC at 13 institutions between November 2024 and March 2025 were retrospectively included in this study. We collected the clinical characteristics and treatment data of the patients and assessed treatment response, progression-free survival (PFS), and adverse events (AEs). Patients were divided into two groups based on CDDP eligibility, and both efficacy and safety were compared between the groups.
RESULTS: The median observation period was 5.56 (IQR, 4.77-6.21) months. Complete response was achieved in 6 (7.9%) patients receiving EV + P, partial response in 40 (52.6%), stable disease in 20 (26.3%), and progressive disease in 10 (13.2%). Six-month and median PFS rates were 80.6% and not reached, respectively. AEs of any grade and grade ≥3 occurred in 59 (77.6%) and 25 (32.9%) patients, respectively. The most frequently observed AE was skin disorders, which occurred in 36 (47.4%) patients; no grade 5 AEs were observed. Treatment response, PFS, and the cumulative incidence of AEs did not differ between CDDP-ineligible and CDDP-eligible patients.
CONCLUSIONS: The short-term efficacy of EV + P treatment seemed comparable to that in previous reports, and the safety profile was acceptable, regardless of CDDP eligibility.
METHODS: Seventy-six patients who received EV + P treatment for advanced UC at 13 institutions between November 2024 and March 2025 were retrospectively included in this study. We collected the clinical characteristics and treatment data of the patients and assessed treatment response, progression-free survival (PFS), and adverse events (AEs). Patients were divided into two groups based on CDDP eligibility, and both efficacy and safety were compared between the groups.
RESULTS: The median observation period was 5.56 (IQR, 4.77-6.21) months. Complete response was achieved in 6 (7.9%) patients receiving EV + P, partial response in 40 (52.6%), stable disease in 20 (26.3%), and progressive disease in 10 (13.2%). Six-month and median PFS rates were 80.6% and not reached, respectively. AEs of any grade and grade ≥3 occurred in 59 (77.6%) and 25 (32.9%) patients, respectively. The most frequently observed AE was skin disorders, which occurred in 36 (47.4%) patients; no grade 5 AEs were observed. Treatment response, PFS, and the cumulative incidence of AEs did not differ between CDDP-ineligible and CDDP-eligible patients.
CONCLUSIONS: The short-term efficacy of EV + P treatment seemed comparable to that in previous reports, and the safety profile was acceptable, regardless of CDDP eligibility.