Furubayashi Nobuki, Mochida Manabu, Kijima Atsuhiro, Fujimoto Yushi, Nakamura Motonobu, Negishi Takahito
Department of Urology, NHO Kyushu Cancer Center, Fukuoka, Japan
Department of Urology, NHO Kyushu Cancer Center, Fukuoka, Japan.
In Vivo. 2025 May-Jun;39(3):1607-1614. doi: 10.21873/invivo.13961.
BACKGROUND/AIM: The impact of steroid premedication on the efficacy and cutaneous toxicity of enfortumab vedotin (EV) in advanced urothelial carcinoma (UC) is unclear.
We retrospectively analyzed consecutive patients with advanced UC who received EV after the failure of platinum-based chemotherapy and immune checkpoint inhibitors from December 2021 to November 2024.
Twenty-eight patients (male, n=16; median age, 71 years) were enrolled. Dexamethasone 6.6 mg was administered intravenously prior to EV in six (21.4%) patients. There were no differences in the overall response and disease control rates between patients with and without steroid premedication (=0.653 and >0.99, respectively). The progression-free survival was not significantly associated with or without steroid premedication (not estimable 4.3 months, =0.501). There were no marked differences in the incidence of all grades of EV-related cutaneous adverse events (AEs) between patients with and without steroid premedication (33.3% 45.5%, =0.673). There was no significant difference in the incidence of grade ≥3 EV-related cutaneous AEs between the patients with and without steroid premedication (16.7% 36.4%, =0.630). Multivariate analysis revealed that a performance status ≥2 was an independent prognostic factor for progression-free survival (hazard ratio=4.653, 95% confidence interval=1.263-17.140, =0.021), and steroid premedication was not ( =0.869).
In EV treatment, steroid premedication did not affect clinical outcomes. The incidence and severity of EV-related cutaneous toxicity tended to improve in patients who received steroid premedication, although no significant differences were observed.
背景/目的:类固醇预处理对晚期尿路上皮癌(UC)患者使用恩杂鲁胺(EV)的疗效和皮肤毒性的影响尚不清楚。
我们回顾性分析了2021年12月至2024年11月期间,在铂类化疗和免疫检查点抑制剂治疗失败后接受EV治疗的晚期UC连续患者。
共纳入28例患者(男性16例;中位年龄71岁)。6例(21.4%)患者在EV治疗前静脉注射地塞米松6.6mg。接受和未接受类固醇预处理的患者在总缓解率和疾病控制率方面无差异(分别为=0.653和>0.99)。无进展生存期与是否接受类固醇预处理无显著相关性(不可估计对4.3个月,=0.501)。接受和未接受类固醇预处理的患者在所有级别的EV相关皮肤不良事件(AE)发生率上无明显差异(33.3%对45.5%,=0.673)。接受和未接受类固醇预处理的患者在≥3级EV相关皮肤AE发生率上无显著差异(16.7%对36.4%,=0.630)。多因素分析显示,体能状态≥2是无进展生存期的独立预后因素(风险比=4.653,95%置信区间=1.263-17.140,=0.021),而类固醇预处理不是(=0.869)。
在EV治疗中,类固醇预处理不影响临床结局。接受类固醇预处理的患者中,EV相关皮肤毒性的发生率和严重程度有改善趋势,尽管未观察到显著差异。