Shindo Tetsuya, Hashimoto Kohei, Takahashi Atsushi, Miyamoto Shintaro, Kunishima Yasuharu, Sato Shunsuke, Fukuta Fumimasa, Hiyama Yoshiki, Takayanagi Akio, Kato Ryuichi, Wanifuchi Atsushi, Ueki Yohei, Okada Manabu, Adachi Hideki, Kobayashi K O, Tanaka Toshiaki, Masumori Naoya
Department of Urology, Sapporo Medical University School of Medicine, Sapporo, Japan;
Department of Urology, Sapporo Medical University School of Medicine, Sapporo, Japan.
Anticancer Res. 2024 Mar;44(3):1271-1279. doi: 10.21873/anticanres.16922.
BACKGROUND/AIM: Sequential therapy using chemotherapy and subsequent immune checkpoint inhibitor (ICI) treatment prolongs the survival of patients with advanced urothelial carcinoma (UC). However, no comparison data for oncological outcome between pembrolizumab and avelumab has been reported. Thus, we compared oncological outcomes between pembrolizumab as second-line therapy and maintenance avelumab therapy in patients with advanced UC.
We retrospectively evaluated patients with advanced UC treated with pembrolizumab or avelumab between January 2018 and February 2023. We compared oncological outcomes after adjusting for patient characteristics. Immune-related adverse events (AEs) in each group were evaluated using the Common Terminology Criteria for Adverse Events.
There were 186 and 44 patients in the pembrolizumab- and avelumab-treated cohorts, respectively. After propensity score matching, 43 patients from each group were selected and analyzed. Median progression-free survival from the initiation of pembrolizumab and avelumab treatments was 126 and 139 days, respectively (log-rank test, p=0.625). Median overall survival in the pembrolizumab and avelumab cohorts were 658 days and not reached, respectively (log-rank test, p=0.249). Thirty-eight (20.4%) and 14 (31.8%) all-grade immune-related AEs were observed in 186 pembrolizumab- and 44 avelumab-treated patients, respectively (chi-squared test, p=0.112). Regarding endocrine-related AEs, 12 (6.5%) and none (0%) were observed in pembrolizumab- and avelumab-treated patients, respectively (Fisher's exact probability test, p=0.129).
Pembrolizumab and maintenance avelumab therapy provide equivalent oncological outcomes in patients with advanced UC. Although no significant difference was observed, there might be a potential risk of higher endocrine-related AEs due to pembrolizumab compared to avelumab maintenance therapy.
背景/目的：采用化疗及后续免疫检查点抑制剂（ICI）治疗的序贯疗法可延长晚期尿路上皮癌（UC）患者的生存期。然而，尚无关于帕博利珠单抗和阿维鲁单抗肿瘤学结局的比较数据报道。因此，我们比较了帕博利珠单抗作为二线治疗与阿维鲁单抗维持治疗在晚期UC患者中的肿瘤学结局。
我们回顾性评估了2018年1月至2023年2月期间接受帕博利珠单抗或阿维鲁单抗治疗的晚期UC患者。我们在对患者特征进行调整后比较了肿瘤学结局。使用不良事件通用术语标准评估每组中的免疫相关不良事件（AE）。
帕博利珠单抗治疗组和阿维鲁单抗治疗组分别有186例和44例患者。在倾向评分匹配后，每组选取43例患者进行分析。从开始使用帕博利珠单抗和阿维鲁单抗治疗起的中位无进展生存期分别为126天和139天（对数秩检验，p = 0.625）。帕博利珠单抗组和阿维鲁单抗组的中位总生存期分别为658天和未达到（对数秩检验，p = 0.249）。在186例接受帕博利珠单抗治疗的患者和44例接受阿维鲁单抗治疗的患者中，分别观察到38例（20.4%）和14例（31.8%）所有级别的免疫相关AE（卡方检验，p = 0.112）。关于内分泌相关AE，在接受帕博利珠单抗治疗的患者和接受阿维鲁单抗治疗的患者中分别观察到12例（6.5%）和0例（0%）（Fisher精确概率检验，p = 0.129）。
帕博利珠单抗和阿维鲁单抗维持治疗在晚期UC患者中提供了相当的肿瘤学结局。尽管未观察到显著差异，但与阿维鲁单抗维持治疗相比，帕博利珠单抗可能存在更高的内分泌相关AE潜在风险。
