Fukushima Takafumi, Numakura Kazuyuki, Shinohara Masanao, Kawashima Yohei, Sekine Yuya, Mori Kanami, Kobayashi Mizuki, Asanuma Himawari, Ichiyama Takaki, Sakurai Hisashi, Ozaki Kai, Fujita Naoki, Okamoto Teppei, Yamamoto Hayato, Yoneyama Takahiro, Sato Satoshi, Habuchi Tomonori, Ohyama Chikara, Hatakeyama Shingo
Department of Urology, Hirosaki University Graduate School of Medicine, 5 Zaifu-cho, Hirosaki, 4079, 036-8562, Japan.
Department of Urology, Akita University Graduate School of Medicine, Akita, Japan.
Sci Rep. 2025 Jul 18;15(1):26127. doi: 10.1038/s41598-025-09806-1.
Enfortumab Vedotin Ineligible criTeriA (EVITA) were proposed for the selection of patients to receive enfortumab vedotin (EV) and pembrolizumab treatment. However, the usefulness of these criteria has not been fully verified. We retrospectively analyzed data from 301 patients with unresectable or metastatic urothelial carcinoma who underwent first-line chemotherapy and 135 patients with EV monotherapy in real-world practice. We evaluated the numbers of patients fulfilling the modified EVITA (mEVITA; excluding ocular abnormalities) and the relationship of the mEVITA to the safety and efficacy in patients with EV monotherapy. Of the 301 patients who received first-line chemotherapy, 4.3% (n = 13) met the mEVITA criteria. The primary factor contributing to mEVITA ≥ 2 was renal dysfunction. Of the 135 patients who underwent subsequent EV therapy, the number of the mEVITA had no influence on the frequency of all-grade and grade ≥ 3 adverse events. However, the mEVITA ≥ 2 was significantly associated with temporary EV interruption. Oncological outcomes were not associated with the number of the mEVITA. In conclusion, 4.3% and 14.8% of patients met the mEVITA criteria at the time of first-line and subsequent EV therapy, respectively. Having mEVITA ≥ 2 may be associated with temporary interruption of EV therapy.
恩诺单抗维妥珠单抗不合格标准（EVITA）被提出用于选择接受恩诺单抗维妥珠单抗（EV）和帕博利珠单抗治疗的患者。然而，这些标准的实用性尚未得到充分验证。我们回顾性分析了301例接受一线化疗的不可切除或转移性尿路上皮癌患者以及135例在真实世界中接受EV单药治疗的患者的数据。我们评估了符合改良EVITA（mEVITA；不包括眼部异常）的患者数量以及mEVITA与接受EV单药治疗患者的安全性和疗效之间的关系。在301例接受一线化疗的患者中，4.3%（n = 13）符合mEVITA标准。导致mEVITA≥2的主要因素是肾功能不全。在135例接受后续EV治疗的患者中，mEVITA的数量对所有级别和≥3级不良事件的发生频率没有影响。然而，mEVITA≥2与EV暂时中断显著相关。肿瘤学结局与mEVITA的数量无关。总之，分别有4.3%和14.8%的患者在一线和后续EV治疗时符合mEVITA标准。mEVITA≥2可能与EV治疗的暂时中断有关。
