维迪西妥单抗联合程序性死亡受体1抑制剂治疗尿路上皮癌的效果及不良反应分析

ABSTRACT：ObjectiveTo evaluate the efficacy and safety of the antibody-drug conjugate（ADC）vedotinumab combined with programmedcelldeath proteinl（PD-1）inhibitors as neoadjuvant therapy inpatients with bladdercancer.Methods This retrospective studyincluded 54 patients with bladder cancer who underwent neoadjuvant therapy at the Departmentof Urology，Peking UniversityFirstHospital，between Jun.2O23and Jun.2O25.Among them，26 patients received vedotinumab combined witha PD-1 inhibitors，and28patientsreceived gemcitabine pluscisplatin（GC）.Clinical data，pathological complete response（pCR）rates，andpathologicaldownstagingrates were collcted.Treatment-relatedadverse events（TRAEs） werealsoasessed inboth groups.ResultsThere wereno statistcallysignificant diferences betweenthetwo groups in terms of age，sex，smoking history，tumorgrade and stage，depthof invasion，or human epidermal growthfactorreceptor2（HER2） expression，indicating good baseline comparability P>0.05 ）.The pCR rate in the vedotinumab plus PD-l inhibitor group was 57.69% （15/26），significantly higher than that of the GC group at 25.00% （7/28）（ P<0.05） .Pathological downstaging occurred in 5 patients in either group，with no statistically significant difference （ P>0. 05） . The main TRAEs in the vedotinumab plus PD-l inhibitor group were peripheral sensory neuropathy and rash，and no grade 3-4 severe adverse events were observed.In contrast，the GC group predominantly experienced bone marrow suppresion，with 4 cases of grade 3-4 （20 adverseevents.ConclusionVedotinumab combined with PD-1 inhibitors demonstrated significantly superior efficacyand favorable safety compared with the conventional GC regimen as neoadjuvant therapy for bladder cancer.

KEY WORDS：vedotinumab; programmedcelldeath1inhibitors；urothelialcarcinoma;gemcitabine;cisplatin;neoadjuvant chemotherapy;antibody-drug conjugates

摘要：目的评估真实世界中抗体偶联药物（ADC）维迪西妥单抗联合程序性死亡受体1（PD-1）抑制剂治疗膀胱癌患者的疗效与安全性。（剩余10207字）