Zhang Tiantian, He Shuo, Tao Lu, Shi Mengting, Wu Yue, Guo Yuanyuan, Wang Rui
Departments of Medical Oncology, The First Affiliated Hospital of Bengbu Medical University, Bengbu, 233004, Anhui, People's Republic of China.
Departments of Urology, The First Affiliated Hospital of Bengbu Medical University, Bengbu, 233004, Anhui, People's Republic of China.
Discov Oncol. 2025 Apr 18;16(1):558. doi: 10.1007/s12672-025-02362-0.
This study aims to assess the efficacy and safety of RC48 in combination with PD-1 inhibitors for patients diagnosed with locally advanced or metastatic urothelial carcinoma (mUC).
A retrospective analysis was performed on clinical data from 53 patients with locally advanced or metastatic bladder cancer, who were treated at the First Affiliated Hospital of Bengbu Medical College between January 2023 and December 2023. The cohort was stratified into two groups: the RC48 combined immunotherapy group (RC48 + PD-1, n = 27) and the conventional chemotherapy group (gemcitabine and cisplatin regimen, GP, n = 26).
The RC48 + PD-1 group demonstrated significantly higher objective response rates (ORR) and median progression-free survival (PFS) compared to the chemotherapy group (P < 0.05). Notably, the incidence of grade 3 or higher adverse events was elevated in the chemotherapy cohort, predominantly due to hematologic toxicities, with no treatment-related fatalities reported. In contrast, the RC48 combined PD-1 group primarily experienced immune-related adverse events, without any incidents of grade 3 or higher adverse effects or treatment-related deaths.
The combination of RC48 and PD-1 inhibitors exhibits promising antitumor activity and a manageable safety profile in patients with locally advanced or metastatic UC.
本研究旨在评估RC48联合PD-1抑制剂治疗局部晚期或转移性尿路上皮癌（mUC）患者的疗效和安全性。
对2023年1月至2023年12月在蚌埠医学院第一附属医院接受治疗的53例局部晚期或转移性膀胱癌患者的临床资料进行回顾性分析。该队列分为两组：RC48联合免疫治疗组（RC48 + PD-1，n = 27）和传统化疗组（吉西他滨和顺铂方案，GP，n = 26）。
与化疗组相比，RC48 + PD-1组的客观缓解率（ORR）和中位无进展生存期（PFS）显著更高（P < 0.05）。值得注意的是，化疗队列中3级或更高等级不良事件的发生率有所升高，主要是由于血液学毒性，未报告与治疗相关的死亡病例。相比之下，RC48联合PD-1组主要经历免疫相关不良事件，未发生3级或更高等级不良事件或与治疗相关的死亡事件。
RC48与PD-1抑制剂联合使用在局部晚期或转移性UC患者中显示出有前景的抗肿瘤活性和可控的安全性。
