Ozaki Kai, Yamamoto Hayato, Sekine Yuya, Horiguchi Hirotaka, Hosogoe Shogo, Mikami Jotaro, Fujita Naoki, Tokui Noriko, Okita Kazutaka, Okamoto Teppei, Mori Kanami, Kobayashi Mizuki, Numakura Kazuyuki, Yoneyama Takahiro, Tabata Ryuji, Sato Satoshi, Habuchi Tomonori, Ohyama Chikara, Hatakeyama Shingo
Department of Urology, Hirosaki University Graduate School of Medicine, Hirosaki, Japan.
Department of Urology, Akita University Graduate School of Medicine, Akita, Japan.
Int J Urol. 2025 Jun;32(6):679-685. doi: 10.1111/iju.70030. Epub 2025 Mar 3.
We aimed to investigate the impact of skin adverse events (AEs) of enfortumab vedotin (EV) on prognosis in patients with locally advanced or metastatic urothelial carcinoma in real-world practice.
This study analyzed data from 115 patients with locally advanced or metastatic urothelial carcinoma. We evaluated the association between EV dose and skin AEs in these patients. The impact of skin AEs on progression-free survival (PFS) and overall survival (OS) was assessed using Kaplan-Meier curves and Cox regression analysis.
The median PFS and OS were 8.1 and 14.5 months, respectively. EV dose reduction was observed in 68 (59.1%) patients. An estimated dose amount in the first, second, and seventh cycles was 95%, 85%, and 81%, respectively. We observed skin AEs in 69 (60%) cases, and they were observed within 1 month in 53 (76.8%) of cases. Patients with skin AEs had significantly longer PFS and OS compared to those without skin AEs. Multivariable Cox regression analysis showed a significant association of skin AEs with prolonged PFS and OS.
Skin AEs were significantly associated with prolonged prognosis compared to those without skin AEs, although EV dose reduction was required in 59.1% of patients. Careful dose adjustment of EV may be crucial for long-term use and optimizing oncological outcomes.
我们旨在研究在现实临床实践中，恩杂鲁胺（EV）的皮肤不良事件（AE）对局部晚期或转移性尿路上皮癌患者预后的影响。
本研究分析了115例局部晚期或转移性尿路上皮癌患者的数据。我们评估了这些患者中EV剂量与皮肤AE之间的关联。使用Kaplan-Meier曲线和Cox回归分析评估皮肤AE对无进展生存期（PFS）和总生存期（OS）的影响。
PFS和OS的中位数分别为8.1个月和14.5个月。68例（59.1%）患者出现了EV剂量减少。第一、第二和第七周期的估计剂量分别为95%、85%和81%。我们观察到69例（60%）出现皮肤AE，其中53例（76.8%）在1个月内出现。与无皮肤AE的患者相比，有皮肤AE的患者PFS和OS明显更长。多变量Cox回归分析显示皮肤AE与PFS和OS延长显著相关。
与无皮肤AE的患者相比，皮肤AE与预后延长显著相关，尽管59.1%的患者需要减少EV剂量。仔细调整EV剂量可能对长期使用和优化肿瘤治疗结果至关重要。
