Department of Urology, Graduate School of Medicine, The University of Tokyo, Bunkyo-ku, Tokyo, Japan.
Department of Urology, Teikyo University School of Medicine, Itabashi-ku, Tokyo, Japan.
Int J Urol. 2023 Dec;30(12):1180-1186. doi: 10.1111/iju.15300. Epub 2023 Sep 22.
Enfortumab vedotin (EV) was approved for advanced urothelial carcinoma (UC) in 2021 after the EV-301 trial showed its superiority to non-platinum-based chemotherapy as later-line treatment after platinum-based chemotherapy and immune checkpoint inhibitors including pembrolizumab. However, no study has compared EV with rechallenging platinum-based chemotherapy (i.e., "platinum rechallenge") in that setting.
In total, 283 patients received pembrolizumab for advanced UC after platinum-based chemotherapy between 2018 and 2023. Of them, 41 and 25 patients received EV and platinum rechallenge, respectively, as later-line treatment after pembrolizumab. After excluding two patients with EV without imaging evaluation, we compared oncological outcomes, including progression-free survival (PFS) and overall survival (OS), between the EV (n = 39) and platinum rechallenge groups (n = 25) using propensity score matching (PSM).
Analyses on crude data (n = 64) showed no significant differences between the two groups regarding patients' baseline characteristics. PFS (5 months) and OS (11 months) in the EV group were comparable to those (8 and 12 months, respectively) in the platinum rechallenge group. After PSM (n = 36), the baseline characteristics between the two groups became more balanced, and PFS (not reached) and OS (not reached) in the EV group were comparable to those (8 and 11 months, respectively) in the platinum rechallenge group.
EV and platinum rechallenge showed equivalent oncological outcomes, even after PSM, and both treatments should therefore be effective treatment options for post-platinum, post-pembrolizumab advanced UC.
在 EV-301 试验表明依维莫司(EV)在铂类化疗后后线治疗中优于非铂类化疗以及包括帕博利珠单抗在内的免疫检查点抑制剂后,EV 于 2021 年被批准用于晚期膀胱癌(UC)。然而,在这种情况下,尚无研究比较 EV 与再挑战铂类化疗(即“铂类再挑战”)。
共有 283 例接受铂类化疗后晚期 UC 的患者于 2018 年至 2023 年间接受了帕博利珠单抗治疗。其中,41 例和 25 例患者分别接受 EV 和铂类再挑战作为帕博利珠单抗后的后线治疗。在排除 2 例无影像学评估的 EV 患者后,我们通过倾向评分匹配(PSM)比较了 EV(n=39)和铂类再挑战组(n=25)的肿瘤学结局,包括无进展生存期(PFS)和总生存期(OS)。
基于原始数据(n=64)的分析显示,两组患者的基线特征无显著差异。EV 组的 PFS(5 个月)和 OS(11 个月)与铂类再挑战组的 PFS(8 个月)和 OS(12 个月)相当。在 PSM 后(n=36),两组间的基线特征更加均衡,EV 组的 PFS(未达到)和 OS(未达到)与铂类再挑战组的 PFS(8 个月)和 OS(11 个月)相当。
EV 和铂类再挑战的肿瘤学结局相当,甚至在 PSM 后也是如此,因此两者均应为铂类、帕博利珠单抗治疗后晚期 UC 的有效治疗选择。