Zhang Chuanao, Yu Yanhang, Zhou Qi, Ouyang Jun, Zhang Zhiyu
Department of Urology, The First Affiliated Hospital of Soochow University, Suzhou, China.
Department of Reproductive Medicine Center, The First Affiliated Hospital of Soochow University, Suzhou, China.
Front Immunol. 2025 Feb 27;16:1549647. doi: 10.3389/fimmu.2025.1549647. eCollection 2025.
Muscle-invasive bladder cancer (MIBC) is an aggressive bladder cancer characterized by invasion of the muscular bladder wall, often necessitating a multimodal treatment approach for optimal outcomes. This study aimed to compare the real-world efficacy and safety of disitamab vedotin (RC48), an antibody-drug conjugate (ADC), combined immunotherapy targeting programmed cell death protein-1 (PD-1), against the gemcitabine and cisplatin (GC) regimen with PD-1 immunotherapy in the treatment of MIBC.
This single-center, retrospective study was conducted at the First Affiliated Hospital of Soochow University and included 38 patients with MIBC treated with either RC48 plus immunotherapy or GC regimen plus immunotherapy, between January 2022 and December 2023. Patients were divided into two groups: the RC48 with immunotherapy (ADC + PD-1) group and the GC regimen with immunotherapy (GC + PD-1) group. Efficacy was evaluated based on their pathological complete response rates (PCRR) and pathological downstaging rates (PDR). Adverse events (AEs) were assessed to compare safety profiles.
Of the 38 patients, 17 were in the ADC + PD-1 group and 21 were in the GC + PD-1 group. The PCRR was significantly higher in the ADC + PD-1 group (82.35%, 14/17) compared to the GC + PD-1 group (47.62%, 10/21; = 0.043). The PDR was also higher in the ADC + PD-1 group (94.12%, 16/17) than in the GC + PD-1 group (80.95%, 17/21), although the difference was not statistically significant ( = 0.355). No serious allergic reactions or fatal AEs were reported in either group. No Grade 4 AEs were reported, while Grade 3 AEs occurred at a rate of 5.71% in the ADC + PD-1 group and 12.20% in the GC + PD-1 group ( = 0.260).
RC48 combined with immunotherapy demonstrated a significantly higher PCRR compared to the GC regimen with immunotherapy, while maintaining a comparable safety profile. These findings highlight the potential of RC48 combined with immunotherapy as an effective treatment option for MIBC in clinical practice.
肌层浸润性膀胱癌（MIBC）是一种侵袭性膀胱癌，其特征是侵犯膀胱肌层，通常需要采用多模式治疗方法以获得最佳疗效。本研究旨在比较抗体药物偶联物（ADC）地西他滨（RC48）联合程序性细胞死亡蛋白1（PD-1）免疫疗法与吉西他滨和顺铂（GC）方案联合PD-1免疫疗法在治疗MIBC方面的真实疗效和安全性。
本单中心回顾性研究在苏州大学附属第一医院进行，纳入了2022年1月至2023年12月期间接受RC48加免疫疗法或GC方案加免疫疗法治疗的38例MIBC患者。患者分为两组：RC48联合免疫疗法（ADC + PD-1）组和GC方案联合免疫疗法（GC + PD-1）组。根据病理完全缓解率（PCRR）和病理降期率（PDR）评估疗效。评估不良事件（AE）以比较安全性。
38例患者中，ADC + PD-1组17例，GC + PD-1组21例。ADC + PD-1组的PCRR（82.35%，14/17）显著高于GC + PD-1组（47.62%，10/21；P = 0.043）。ADC + PD-1组的PDR（94.12%，16/17）也高于GC + PD-1组（80.95%，17/21），尽管差异无统计学意义（P = 0.355）。两组均未报告严重过敏反应或致命AE。未报告4级AE，ADC + PD-1组3级AE发生率为5.71%，GC + PD-1组为12.20%（P = 0.260）。
与GC方案联合免疫疗法相比，RC48联合免疫疗法的PCRR显著更高，同时安全性相当。这些发现凸显了RC48联合免疫疗法在临床实践中作为MIBC有效治疗选择的潜力。
