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 (p< 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期临床试验结果表明，恩福单抗维多汀（EV）作为一种由抗Nectin-4人源IgG1单克隆抗体与单甲基奥瑞他汀E组成的抗体偶联药物（ADC），对于免疫检查点抑制剂（ICI）治疗后进展的局部晚期或转移性尿路上皮癌（la/mUC）患者具有显著疗效。本项多中心回顾性队列研究旨在临床实践中识别EV治疗疗效及患者总生存期（OS）延长的预测因素。研究纳入接受过ICI治疗的la/mUC患者，将后续接受EV治疗、接受非EV化疗以及未接受治疗的患者分别定义为EV组、非EV组和最佳支持治疗（BSC）组。三组中位OS分别为20个月、15个月和7个月（p<0.001）。EV治疗后达到完全或部分缓解的la/mUC患者，其OS较疾病稳定或进展患者显著延长。单变量分析显示年龄、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。多变量分析证实NLR和味觉障碍是EV治疗后OS的独立预测指标。不具备这些危险因素的患者较同时具备两项因素者OS显著延长。真实世界研究表明，EV治疗是ICI治疗后la/mUC患者的有效治疗方案。
肿瘤(癌症)患者之家