Liu Tian, Xie Xiao, Ren Yangz-Zi, Li Zongyu, Cai Maoping, Yu Yuzhong, Zhuo Lin
Department of Urology, Pingxiang Affiliated Hospital, Pingxiang, China.
Department of Oncology, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China.
Front Pharmacol. 2025 Sep 1;16:1583654. doi: 10.3389/fphar.2025.1583654. eCollection 2025.
Antibody-drug conjugates (ADCs) offer novel therapeutic options for advanced urological cancers, but their efficacy and safety vary across cancer types. Many non-urothelial cancer ADC trials are small, nonrandomized studies with limited validated evaluation indicators. The purpose of this study is to evaluate the efficacy and safety of ADCs across various urological cancers.
Relevant studies were identified through searches in Embase, PubMed, Web of Science, Cochrane Library, CNKI, VIP database and WanFang dataset, including randomized controlled trials, single-arm studies, and retrospective analyses on ADCs for advanced urological cancers. RoB 2.0, MINORS, and NOS were used for quality assessment, with R 4.4.0 for data analysis.
This meta-analysis included 46 studies with 3,250 patients, covering urothelial cancer (29 studies), renal cell carcinoma (5 studies), testicular cancer (2 studies), and metastatic castration-resistant prostate cancer (10 studies). Three ADCs for urothelial cancer have received approval, including enfortumab vedotin (EV), sacituzumab govitecan (SG), and the HER2-ADC vedicilizumab (RC-48)/disitamab vedotin (DV). For urothelial cancer, the pooled overall response rate (ORR) was 43% (95% CI: 39%-47%) and disease control rate (DCR) was 76% (95% CI: 71%-80%). Median overall survival (OS) and progression-free survival (PFS) were 11.55 months (95% CI: 10.63-12.47) and 5.52 months (95% CI: 5.32-5.72) for enfortumab vedotin (EV), and 15.30 months (95% CI: 11.21-19.40) and 5.80 months (95% CI: 4.88-6.72) for DV. DV combined with immunotherapy achieved a pooled median PFS of 9.78 months (95% CI: 7.73-11.83). For renal cell carcinoma, the ORR was 6% (95% CI: 2%-10%) with median OS of 12.71 months (95% CI: 9.67-15.75). For metastatic castration-resistant prostate cancer, ADC efficacy was higher in chemotherapy-experienced patients (ORR: 17% vs. 5%).
ADCs demonstrate efficacy and safety in treating urological cancers, but further clinical trials are needed, particularly for renal, testicular, and prostate cancers, to support personalized treatment strategies.
抗体药物偶联物（ADC）为晚期泌尿系统癌症提供了新的治疗选择，但其疗效和安全性因癌症类型而异。许多非尿路上皮癌ADC试验规模较小，为非随机研究，且验证的评估指标有限。本研究的目的是评估ADC在各种泌尿系统癌症中的疗效和安全性。
通过检索Embase、PubMed、Web of Science、Cochrane图书馆、中国知网、维普数据库和万方数据集来识别相关研究，包括随机对照试验、单臂研究以及对晚期泌尿系统癌症ADC的回顾性分析。采用RoB 2.0、MINORS和NOS进行质量评估，使用R 4.4.0进行数据分析。
该荟萃分析纳入了46项研究，共3250例患者，涵盖尿路上皮癌（29项研究）、肾细胞癌（5项研究）、睾丸癌（2项研究）和转移性去势抵抗性前列腺癌（10项研究）。三种用于尿路上皮癌的ADC已获批准，包括恩扎妥单抗（EV）、戈沙妥珠单抗（SG）以及HER2-ADC维迪西妥单抗（RC-48）/迪西妥单抗（DV）。对于尿路上皮癌，汇总的总缓解率（ORR）为43%（95%CI：39%-47%），疾病控制率（DCR）为76%（95%CI：71%-80%）。恩扎妥单抗（EV）的中位总生存期（OS）和无进展生存期（PFS）分别为11.55个月（95%CI：10.63-12.47）和5.52个月（95%CI：5.32-5.72），迪西妥单抗（DV）的分别为15.30个月（95%CI：11.21-19.40）和5.80个月（95%CI：4.88-6.72）。DV联合免疫疗法的汇总中位PFS为9.78个月（95%CI：7.73-11.83）。对于肾细胞癌，ORR为6%（95%CI：2%-10%），中位OS为12.71个月（95%CI：9.67-15.75）。对于转移性去势抵抗性前列腺癌，化疗经验丰富的患者中ADC疗效更高（ORR：17%对5%）。
ADC在治疗泌尿系统癌症方面显示出疗效和安全性，但需要进一步的临床试验，特别是针对肾癌、睾丸癌和前列腺癌，以支持个性化治疗策略。
