Nakane Keita, Taniguchi Kazuki, Nezasa Minori, Enomoto Torai, Yamada Toyohiro, Tomioka-Inagawa Risa, Niwa Kojiro, Tomioka Masayuki, Ishida Takashi, Nagai Shingo, Yokoi Shigeaki, Taniguchi Tomoki, Kawase Makoto, Kawase Kota, Iinuma Koji, Tobisawa Yuki, Koie Takuya
Department of Urology, Gifu University Graduate School of Medicine, Gifu 5011194, Japan.
Department of Urology, Gifu Prefectural General Medical Center, Gifu 5008717, Japan.
Cancers (Basel). 2024 Jul 25;16(15):2648. doi: 10.3390/cancers16152648.
Randomized phase III trial results have demonstrated enfortumab vedotin (EV), an antibody-drug conjugate (ADC) consisting of an anti-Nectin-4 human IgG1 monoclonal antibody and monomethyl auristatin E, is a useful treatment for patients with locally advanced or metastatic urothelial carcinoma (la/mUC) that progressed after immune checkpoint inhibitor (ICI) therapies. This multicenter retrospective cohort study aimed to identify predictive factors for the efficacy of EV therapy and prolonged overall survival (OS) of patients in clinical practice. This study included patients with la/mUC who received ICI treatment. Patients who subsequently received EV treatment, those who received non-EV chemotherapy, and those who received no treatment were defined as EV, non-EV, and best supportive care (BSC) groups, respectively. The median OS was 20, 15, and 7 months in the EV, non-EV, and BSC groups, respectively ( < 0.001). Patients with la/mUC who had a complete or partial response after EV treatment had a significantly prolonged OS compared with those with stable or progressive disease. Univariate analysis showed age, neutrophil-to-lymphocyte ratio (NLR), dysgeusia, and rash as independent predictors of OS improvement. NLR and dysgeusia were independent predictors of OS after EV in multivariate analysis. Patients without these factors had a significantly prolonged OS compared to those with both factors. In real-world practice, EV therapy is an effective treatment for patients with la/mUC after ICI treatment.
随机III期试验结果表明，恩杂鲁胺（EV）是一种抗体药物偶联物（ADC），由抗Nectin-4人IgG1单克隆抗体和单甲基奥瑞他汀E组成，是治疗局部晚期或转移性尿路上皮癌（la/mUC）患者的有效方法，这些患者在免疫检查点抑制剂（ICI）治疗后病情进展。这项多中心回顾性队列研究旨在确定临床实践中EV治疗疗效和患者总生存期（OS）延长的预测因素。该研究纳入了接受ICI治疗的la/mUC患者。随后接受EV治疗的患者、接受非EV化疗的患者和未接受治疗的患者分别被定义为EV组、非EV组和最佳支持治疗（BSC）组。EV组、非EV组和BSC组的中位OS分别为20个月、15个月和7个月（<0.001）。EV治疗后有完全或部分缓解的la/mUC患者的OS明显长于病情稳定或进展的患者。单因素分析显示年龄、中性粒细胞与淋巴细胞比值（NLR）、味觉障碍和皮疹是OS改善的独立预测因素。多因素分析中，NLR和味觉障碍是EV治疗后OS的独立预测因素。没有这些因素的患者与有这两个因素的患者相比，OS明显延长。在实际临床实践中，EV治疗是ICI治疗后la/mUC患者的有效治疗方法。
