Ishikawa Gaku, Matsushita Yuto, Kitagawa Yuichi, Uchiyama Asuka, Oishi Yuya, Tanaka Hiroki, Watanabe Shinya, Suzuki Eito, Watanabe Shunsuke, Watanabe Kyohei, Watanabe Hiromitsu, Tamura Keita, Motoyama Daisuke, Matsumoto Rikiya, Ito Toshiki, Nagata Masao, Unno Toshiyuki, Furuse Hiroshi, Mizuno Takuji, Otsuka Atsushi
Department of Urology, Hamamatsu University School of Medicine, Hamamatsu, Japan.
Department of Urology, JA Shizuoka Kohseiren Enshu Hospital, Hamamatsu, Japan.
Cancer Diagn Progn. 2024 Nov 3;4(6):783-788. doi: 10.21873/cdp.10396. eCollection 2024 Nov-Dec.
BACKGROUND/AIM: Enfortumab Vedotin (EV) is a widely used antibody-drug conjugate for patients with advanced urothelial carcinoma (UC) who have previously been treated with platinum-based chemotherapy and immune checkpoint inhibitors. However, limited information is currently available on prognostic factors and risk classification. Therefore, the present study attempted to identify clinical factors that predict outcomes in patients with advanced UC treated with EV and to develop a novel risk classification model.
We conducted a multicenter retrospective study including patients with advanced UC treated with EV. Oncological outcomes were assessed using progression-free survival (PFS) and overall survival (OS), and prognostic factors for PFS and OS were investigated. We then examined the usefulness of risk classification based on the prognostic factors identified.
Median PFS and OS were 7.1 and 16.3 months, respectively. High C-reactive protein levels (CRP level ≥0.5 mg/dl) and hypercalcemia (corrected calcium level >10.2 mg/dl) were identified as prognostic factors for PFS (p=0.012 and p=0.003, respectively) and OS (p=0.035 and p<0.001, respectively). We then divided patients into three risk groups: no prognostic factors group, one prognostic factor group, and two prognostic factors group. Significant differences were observed in PFS and OS among the three groups (p<0.001 and p<0.001, respectively) and c-indices were 0.766 for PFS and 0.800 for OS.
The risk classification using CRP and hypercalcemia is useful for predicting the outcomes of patients with advanced UC treated with EV.
背景/目的：恩杂鲁胺（EV）是一种广泛应用于晚期尿路上皮癌（UC）患者的抗体药物偶联物，这些患者此前接受过铂类化疗和免疫检查点抑制剂治疗。然而，目前关于预后因素和风险分类的信息有限。因此，本研究试图确定预测接受EV治疗的晚期UC患者预后的临床因素，并开发一种新的风险分类模型。
我们进行了一项多中心回顾性研究，纳入接受EV治疗的晚期UC患者。使用无进展生存期（PFS）和总生存期（OS）评估肿瘤学结局，并研究PFS和OS的预后因素。然后，我们根据所确定的预后因素检查风险分类的实用性。
中位PFS和OS分别为7.1个月和16.3个月。高C反应蛋白水平（CRP水平≥0.5mg/dl）和高钙血症（校正钙水平>10.2mg/dl）被确定为PFS（分别为p=0.012和p=0.003）和OS（分别为p=0.035和p<0.001）的预后因素。然后，我们将患者分为三个风险组：无预后因素组、一个预后因素组和两个预后因素组。三组之间在PFS和OS方面观察到显著差异（分别为p<0.001和p<0.001），PFS的c指数为0.766，OS的c指数为0.800。
使用CRP和高钙血症进行风险分类有助于预测接受EV治疗的晚期UC患者的预后。
