文章：

C反应蛋白是恩诺单抗治疗晚期或转移性尿路上皮癌患者的潜在预后标志物：一项多中心回顾性研究

C-Reactive Protein Is a Potential Prognostic Marker in Patient with Advanced or Metastatic Urothelial Carcinoma Treated with Enfortumab Vedotin: A Multi-Center Retrospective Study

原文发布日期：28 April 2024

DOI: 10.3390/cancers16091725

类型: Article

开放获取: 是

英文摘要：

Background: In the EV-301 trial, enfortumab vedotin prolonged survival in patients with locally advanced or metastatic urothelial carcinoma previously treated with platinum-based therapy and programmed cell death 1/programmed death-ligand 1 inhibitor. However, real-world Asian data are limited, and potential prognostic markers are non-existent. We aimed to investigate potential prognostic markers for enfortumab vedotin therapy in Asian patients. Methods: We retrospectively enrolled 61 Japanese patients treated with enfortumab vedotin therapy at our hospital and affiliated hospitals between January 2019 and September 2023. Results: Enrolled patients (38 men, 23 women; median age 74 [IQR: 68–79] years) had bladder cancer (26 patients) or upper-tract urothelial carcinoma (35 patients). Fifty-four patients reported adverse events (grade >3 in 12). Skin disorders, pruritus, and neuropathy were common adverse effects. The median overall survival was 17.1 months (95% confidence interval: 10.0–not applicable). In multivariate analysis, the C-reactive protein level was an independent marker predicting favorable overall survival with enfortumab vedotin. Patient characteristics did not differ between C-reactive protein-high and -low groups. Conclusions: Our study provides real-world data showing that enfortumab vedotin prolonged survival in Asian patients similar to the EV-301 trial. Additionally, the C-reactive protein level might be considered a prognostic marker of enfortumab vedotin therapy in such patients.

摘要翻译： 

背景：在EV-301试验中，enfortumab vedotin（维迪西妥单抗）可延长既往接受过铂类化疗及程序性死亡受体1/程序性死亡配体1抑制剂治疗的局部晚期或转移性尿路上皮癌患者的生存期。然而，亚洲地区的真实世界数据有限，且缺乏潜在的预后标志物。本研究旨在探索亚洲患者接受enfortumab vedotin治疗的潜在预后标志物。 方法：我们回顾性纳入2019年1月至2023年9月期间在本院及附属医院接受enfortumab vedotin治疗的61例日本患者。 结果：入组患者（男性38例，女性23例；中位年龄74岁[四分位距：68-79岁]）包括膀胱癌（26例）和上尿路尿路上皮癌（35例）。54例患者报告了不良事件（其中12例为3级以上）。皮肤病变、瘙痒和神经病变是常见的不良反应。中位总生存期为17.1个月（95%置信区间：10.0-未达到）。多变量分析显示，C反应蛋白水平是预测enfortumab vedotin治疗良好总生存期的独立标志物。高C反应蛋白组与低C反应蛋白组患者的基线特征无显著差异。 结论：本研究提供的真实世界数据表明，enfortumab vedotin可延长亚洲患者的生存期，与EV-301试验结果一致。此外，C反应蛋白水平可能作为此类患者接受enfortumab vedotin治疗的预后标志物。

原文链接：

C-Reactive Protein Is a Potential Prognostic Marker in Patient with Advanced or Metastatic Urothelial Carcinoma Treated with Enfortumab Vedotin: A Multi-Center Retrospective Study