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Mechanisms, Clinical Trials, and New Treatments for BCG-Unresponsive in Nonmuscle Invasive Bladder Cancer

文献类型：期刊论文

作者Huang, Xiaotong7; Wang, Xuan6; He, Zihe5; Huang, Yishu4; Hu, Bing4; Chen, Weiying3,7; Du, Haifang1,2,7
刊名CANCER MEDICINE
出版日期2025-09-15
卷号14期号:18页码:17
关键词BCG treatment BCG vaccine replacement therapy BCG-unresponsive treatment bladder cancer gene therapy immune checkpoint inhibitors photodynamic therapy targeted therapy
ISSN号2045-7634
DOI10.1002/cam4.71243
通讯作者Chen, Weiying(weiyingchen2007@163.com) ; Du, Haifang(haifangdu@gzucm.edu.cn)
英文摘要Background Bacillus Calmette-Gu & eacute;rin (BCG) is the standard adjuvant therapy for high-risk non-muscle invasive bladder cancer (NMIBC), yet treatment failure occurs in 30% to 40% of patients. Those with BCG-unresponsive disease face a high risk of progression and represent a critical unmet need in urologic oncology. This review summarizes the mechanisms of BCG failure and evaluates emerging therapies for BCG-unresponsive NMIBC.Methods We conducted a comprehensive literature review of clinical trials and preclinical studies through August 2025, focusing on therapeutic strategies for BCG-unresponsive NMIBC. Mechanisms of BCG resistance, regulatory definitions, and results from recent Phase II/III trials were analyzed.Results Multiple novel therapies have demonstrated efficacy in BCG-unresponsive patients. Immune checkpoint inhibitors (e.g., pembrolizumab) achieved complete response (CR) rates of 41% in carcinoma in situ (CIS) patients. Gene therapies such as nadofaragene firadenovec and CG0070 induced CR rates of 51% and 75%, respectively. Device-assisted therapies including hyperthermic intravesical chemotherapy (HIVEC) showed 24-month recurrence-free survival of 57.4%. The IL-15 superagonist Anktiva (nogapendekin alfa inbakicept), recently FDA-approved, achieved a 71% CR rate with a median duration of 26.6 months when combined with BCG.Conclusions The treatment landscape for BCG-unresponsive NMIBC is rapidly evolving, with immune checkpoint inhibitors, gene therapies, targeted agents, and advanced drug delivery systems showing promising efficacy. These innovations provide bladder-preserving options for patients ineligible for radical cystectomy. Future directions include biomarker-driven therapy selection, combination regimens, and optimized intravesical delivery platforms to improve long-term outcomes.
WOS关键词BACILLUS-CALMETTE-GUERIN ; METASTATIC UROTHELIAL CARCINOMA ; TOLL-LIKE RECEPTORS ; SINGLE-ARM ; OPEN-LABEL ; THERAPY ; MULTICENTER ; PEMBROLIZUMAB ; METAANALYSIS ; MONOTHERAPY
资助项目National Natural Science Foundation of China
WOS研究方向Oncology
语种英语
WOS记录号WOS:001571096500001
出版者WILEY
源URL[http://119.78.100.183/handle/2S10ELR8/321489]  
专题中国科学院上海药物研究所
通讯作者Chen, Weiying; Du, Haifang
作者单位1.Hunan Yueyang Maternal & Child Hlth Care Hosp, Yueyang, Peoples R China
2.Guangdong Prov Key Lab Clin Res Tradit Chinese Med, Guangzhou, Peoples R China
3.Guangdong Prov Key Lab Chinese Med Prevent & Treat, Guangzhou, Peoples R China
4.Guangdong Pharmaceut Univ, Guangzhou, Peoples R China
5.Xian Jiaotong Liverpool Univ, Suzhou, Peoples R China
6.Chinese Acad Sci, Zhongshan Inst Drug Discovery, Shanghai Inst Mat Med, Zhongshan, Peoples R China
7.Guangzhou Univ Chinese Med, Guangdong Prov Hosp Chinese Med, Affiliated Hosp 2, Guangzhou, Peoples R China
推荐引用方式
GB/T 7714		 Huang, Xiaotong,Wang, Xuan,He, Zihe,et al. Mechanisms, Clinical Trials, and New Treatments for BCG-Unresponsive in Nonmuscle Invasive Bladder Cancer[J]. CANCER MEDICINE,2025,14(18):17.
APA Huang, Xiaotong.,Wang, Xuan.,He, Zihe.,Huang, Yishu.,Hu, Bing.,...&Du, Haifang.(2025).Mechanisms, Clinical Trials, and New Treatments for BCG-Unresponsive in Nonmuscle Invasive Bladder Cancer.CANCER MEDICINE,14(18),17.
MLA Huang, Xiaotong,et al."Mechanisms, Clinical Trials, and New Treatments for BCG-Unresponsive in Nonmuscle Invasive Bladder Cancer".CANCER MEDICINE 14.18(2025):17.

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来源：上海药物研究所

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