Clinical efficacy and safety analysis of disitamab vedotin combined with tislelizumab in first-line treatment of advanced metastatic urothelial carcinoma
10.12354/j.issn.1000-8179.2025.20250333
- VernacularTitle:维迪西妥单抗联合替雷利珠单抗在晚期转移性尿路上皮癌一线治疗中的临床疗效与安全性分析
- Author:
Se HAN
1
;
Li SANXIANG
;
Si RIGULENG
;
Su ZENONG
;
Lu CHAO
;
Jing JING
;
Li HAOJING
;
Yang HONG
Author Information
1. 包头医学院研究生院(内蒙古自治区 包头市 014040);内蒙古自治区人民医院/内蒙古大学人民医院肿瘤内科
- Publication Type:Journal Article
- Keywords:
disitamab vedotin;
antibody-drug conjugates(ADCs);
tislelizumab;
metastatic urothelial carcinoma(mUC)
- From:
Chinese Journal of Clinical Oncology
2025;52(7):331-337
- CountryChina
- Language:Chinese
-
Abstract:
Objective:Patients with metastatic urothelial carcinoma(mUC)usually receive platinum-based chemotherapy as the first-line treatment.Recently,antibody-drug conjugates(ADCs)combined with programmed death-1 antibody(PD-1 antibody)have shown promising efficacy and safety in the treatment of mUC.HER2 positivity is associated with poor prognosis,patients can benefit from anti-HER2 ADC therapy such as disitamab vedotin(RC48-ADC).This study aimed to evaluate the efficacy and safety of RC48-ADC combined with tislelizu-mab in treatment-na?ve patients with mUC.Methods:A retrospective analysis was performed on 70 mUC patients treated between July 2022 and December 2023,including 30 patients receiving RC48-ADC combined with tislelizumab(DT group)and 40 patients receiving gem-citabine plus cisplatin(GC group).Primary endpoints included objective response rate(ORR),disease control rate(DCR),progression-free survival(PFS),overall survival(OS),and treatment-related adverse events(TRAEs).Results:The ORR(73.3%vs.47.5%)and DCR(86.7%vs.62.5%)were significantly higher in the DT group compared to the GC group(P<0.05).The DT group also demonstrated longer PFS(10.98 months vs.7.67 months,P<0.005)and prolonged OS(median OS:not reached vs.11.34 months).The most common TRAEs included myel-osuppression,gastrointestinal and hepatobiliary toxicities,fatigue,alopecia,and rash.No grade≥3 TRAEs or treatment-related deaths were reported.Conclusions:RC48-ADC combined with tislelizumab demonstrated superior efficacy and favorable safety in treatment-na?ve pa-tients with mUC,supporting its potential as a first-line therapeutic option.
