Department of Urology, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan;
Department of Urology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.
Anticancer Res. 2024 Aug;44(8):3419-3426. doi: 10.21873/anticanres.17162.
BACKGROUND/AIM: This study retrospectively evaluated whether enfortumab vedotin (EV) monotherapy is effective as a late-line treatment according to prior treatment type in patients with advanced urothelial carcinoma (UC).
We assessed consecutive patients from the Uro-Oncology Group in the Kyushu study population with lower and upper urinary tract cancer treated with EV monotherapy after platinum-based chemotherapy and immune checkpoint inhibitor therapy failure between December 2021 and March 2024. In particular, patients receiving avelumab maintenance or pembrolizumab therapy before EV for advanced UC were analyzed and compared according to the response rate, progression-free survival (PFS), and overall survival (OS).
Of the 80 enrolled patients, 31 and 49 received avelumab and pembrolizumab before EV therapy, respectively. The avelumab and pembrolizumab groups had comparable objective response rates (48.4% vs. 44.9%, p=0.820) and disease control rates (77.4% vs. 67.3%, p=0.448). These two groups showed no significant difference in PFS from the initiation of EV (median: 6.4 months vs. 4.2 months, p=0.184); meanwhile, the avelumab group had better OS from the initiation of EV than the pembrolizumab group (median: 16.0 months vs. 10.2 months, p=0.019). Moreover, the median OS after first-line chemotherapy initiation was longer in the avelumab group than in the pembrolizumab group (40.3 months vs. 24.7 months, p=0.054). On multivariate analysis, avelumab maintenance therapy before EV reduced the mortality risk by 47% (95% confidence interval=0.27-1.03; p=0.059).
EV monotherapy after avelumab maintenance therapy provides favorable survival outcomes in patients with advanced UC.
背景/目的:本研究回顾性评估了依伏替尼(EV)单药治疗在铂类化疗和免疫检查点抑制剂治疗失败后,根据既往治疗类型,在晚期尿路上皮癌(UC)患者中的晚期线治疗效果。
我们评估了 2021 年 12 月至 2024 年 3 月期间,九州肿瘤学组中接受 EV 单药治疗的下尿路和上尿路癌症连续患者,这些患者在铂类化疗和免疫检查点抑制剂治疗失败后接受了 EV 单药治疗。特别分析了接受 EV 治疗前接受avelumab 维持或 pembrolizumab 治疗的晚期 UC 患者,并根据客观缓解率(ORR)、无进展生存期(PFS)和总生存期(OS)进行了比较。
在 80 名入组患者中,31 名和 49 名患者分别在 EV 治疗前接受了 avelumab 和 pembrolizumab 治疗。avelumab 和 pembrolizumab 组的客观缓解率(48.4% vs. 44.9%,p=0.820)和疾病控制率(77.4% vs. 67.3%,p=0.448)相当。从 EV 治疗开始,两组患者的 PFS 无显著差异(中位:6.4 个月 vs. 4.2 个月,p=0.184);同时,从 EV 治疗开始,avelumab 组的 OS 优于 pembrolizumab 组(中位:16.0 个月 vs. 10.2 个月,p=0.019)。此外,avelumab 组患者从一线化疗开始的中位 OS 长于 pembrolizumab 组(40.3 个月 vs. 24.7 个月,p=0.054)。多变量分析显示,EV 治疗前接受 avelumab 维持治疗可降低 47%的死亡率(95%置信区间=0.27-1.03;p=0.059)。
EV 单药治疗在晚期 UC 患者中,在接受 avelumab 维持治疗后可获得较好的生存获益。