The efficacy and safety of disitamab vedotin combined with immune checkpoint inhibitors in metastatic upper tract urothelial carcinoma: a multicenter real-world study
Year: 2025
Type: article
Study design: Observational Study
Abstract: BACKGROUND: Disitamab vedotin (DV, RC48-ADC) has shown promising efficacy and manageable safety as monotherapy or combined with immune checkpoint inhibitors (ICIs) in metastatic urothelial carcinoma (mUC) patients progressing after systemic chemotherapy. This study evaluates the efficacy and safety of RC48-ADC plus ICIs in metastatic upper tract urothelial carcinoma (mUTUC) in a real-world setting. METHODS: This retrospective, multicenter study included 198 mUTUC patients treated with RC48-ADC plus ICI at 23 clinical centers between June 2021 and December 2023. Data were analyzed from July to September 2024. PRIMARY ENDPOINT: objective response rate (ORR). Secondary endpoints: progression-free survival (PFS), overall survival (OS), duration of response (DoR), time to objective response, and treatment-related adverse events (TRAEs). RESULT: Among the patients, 122 (61.6%) received combination therapy as first-line treatment, while 76 (38.4%) as second-line or beyond. ORR was 58.6% (95% CI: 51.4-65.5), with a median PFS of 13.0 months; median OS was not reached. Subgroup analyses showed consistent ORR across all subgroups. Adverse events (AEs) occurred in 79.8% of patients, with grade 3-4 AEs in 19.7%. Common AEs included neuropathy (40.4%), fatigue (26.8%), alopecia (25.3%), and rash (21.7%). The main limitations of this study include its retrospective design and the population of the study only include patients from China, leading to potential selection bias. CONCLUSIONS: RC48-ADC combined with ICIs demonstrated robust antitumor activity and a favorable safety profile in real-world mUTUC, particularly in selected patient groups. Further studies are needed to explore its potential in this high-risk population.
Source: Cancer Immunology Immunotherapy
Authors: Cheoklong Ng, Taile Jing, Shicheng Yu, Jianjun Ye, Shun Zhang, Zhankui Jia, Qi Tang, Xiaoyi Hu, Minfeng Chen, Weiping Huang, Jitao Wu, Hai Bi, Zejun Yan, Haibo Shen, Wei Xiong, Zheng Liu, Jun Xiao, Tao Zhang, Xuedong Wei, Hailong Hu, Qing Yang, Yichu Yuan, Zhiyang Huang, Wei Xue, Yige Bao, Guoqing Ding, Dan Xia, Jiwei Huang
Institutions: Shanghai Jiao Tong University, Renji Hospital, First Affiliated Hospital Zhejiang University, Zhejiang University, Sir Run Run Shaw Hospital, Sichuan University, West China Hospital of Sichuan University, Nanjing Drum Tower Hospital, Nanjing University, First Affiliated Hospital of Zhengzhou University, Peking University, Peking University First Hospital, Fudan University, Zhongshan Hospital, Central South University, Xiangya Hospital Central South University, First Affiliated Hospital of Wenzhou Medical University, Qingdao University, Yuhuangding Hospital, Shanghai First People's Hospital, Ningbo University, XinHua Hospital, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Tongji Hospital, Huazhong University of Science and Technology, University of Science and Technology of China, Anhui Medical University, Second Affiliated Hospital of Anhui Medical University, First Affiliated Hospital of Soochow University, Second Hospital of Tianjin Medical University, Tianjin Medical University, Shanghai Ninth People's Hospital, Second Affiliated Hospital of Zhejiang University, Fujian Medical University
Language: English
Subfield: Surgery
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $4,590
OpenAlex ID: W4414161981