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Treatment and surveillance for non-muscle-invasive bladder cancer:a clinical practice guideline(2021 edition)

Military Medical Research 2023年第2期10卷 141-161页

作者： Ying-Hui Jin Xian-Tao Zeng Tong-Zu Liu Zhi-Ming Bai Zhong-Ling Dou De-Gang Ding Zhi-Lu Fan Ping Han Yi-Ran Huang Xing Huang Ming Li Xiao-Dong Li Yi-Ning Li Xu-Hui Li Chao-Zhao Liang Jiu-Min Liu Hong-Shun Ma Juan Qi Jia-Qi Shi Jian Wang De-Lin Wang Zhi-Ping Wang Yun-Yun Wang Yong-Bo Wang Qiang Wei Hai-Bo Xia Jin-Chun Xing Si-Yu Yan Xue-Pei Zhang Guo-You Zheng Nian-Zeng Xing Da-Lin He Xing-Huan Wang on behalf of the Chinese Urological Doctor Association(CUDA),Urological Association of Chinese Research Hospital Association(CRHA-UA),Uro-Health Promotive Association of China International Exchange,Promotive Association for Medical,Health Care(CPAM-UHPA) Center for Evidence-Based and Translational Medicine Zhongnan Hospital of Wuhan UniversityWuhan 430071China Department of Urology Institute of UrologyZhongnan Hospital of Wuhan UniversityWuhan 430071China Department of Urology Haikou People’s HospitalHaikou Afliated Hospital of Central South University Xiangya School of MedicineHaikou 570208China Department of Urology the First Afliated Hospital and College of Clinical MedicineHenan University of Science and TechnologyLuoyang 450052HenanChina Department of Urology Henan Provincial People’s Hospi-talZhengzhou University People’s HospitalZhengzhou 450003China Department of Urology the Second Hospital of Dalian Medical UniversityDalian 116023LiaoningChina Department of Urology Institute of UrologyWest China HospitalSichuan UniversityChengdu 610041China Department of Urology Renji HospitalSchool of MedicineShanghai Jiao Tong UniversityShanghai 200120China Department of Urology the People’s Hos-pital of Xinjiang Uygur Autonomous RegionUrumqi 830002China Depart-ment of Urology Huaihe Hospital of Henan UniversityKaifeng 475000HenanChina Institutes of Evidence-Based Medicine and Knowledge Translation Henan UniversityKaifeng 475000HenanChina Department of Urology the Second Afliated Hospital and Second Clinical Medical College of Fujian Medical UniversityQuanzhou 362000FujianChina Department of Urol-ogy the First Afliated Hospital of Anhui Medical UniversityHefei 230022China Department of Urology Guangdong Provincial People’s HospitalGuangdong Academy of Medical SciencesGuangzhou 510080China Department of Urology Tianjin First Central HospitalTianjin 300190China Department of Urology Xinhua HospitalSchool of MedicineShanghai Jiao Tong University School of MedicineShanghai 200092China Department of Urology Afliated Hospital of Guizhou Medical UniversityGuiyang 550004China Department of Urology Qinghai University Afliated HospitalXining 810012China Department of Urology the First Afliated Hospital of Chongqing Medical Univ

non-muscle invasive bladder cancer(NMIBC)is a major type of bladder cancer with a high incidence worldwide,resulting in a great disease burden.Treatment and surveillance are the most important part of NIMBC management.In 2018,we issued“Treatment and surveillance for non-muscle-invasive bladder cancer in China:an evidencebased clinical practice guideline”.Since then,various studies on the treatment and surveillance of NMIBC have been published.There is a need to incorporate these materials and also to take into account the relatively limited medical resources in primary medical institutions in China.Developing a version of guideline which takes these two issues into account to promote the management of NMIBC is therefore indicated.We formed a working group of clinical experts and methodologists.Through questionnaire investigation of clinicians including primary medical institutions,24 clinically concerned issues,involving transurethral resection of bladder tumor(TURBT),intravesical chemotherapy and intravesical immunotherapy of NMIBC,and follow-up and surveillance of the NMIBC patients,were determined for this guideline.Researches and recommendations on the management of NMIBC in databases,guideline development professional societies and monographs were referred to,and the European Association of Urology was used to assess the certainty of generated recommendations.Finally,we issued 29 statements,among which 22 were strong recommendations,and 7 were weak recommendations.These recommendations cover the topics of TURBT,postoperative chemotherapy after TURBT,Bacillus Calmette–Guérin(BCG)immunotherapy after TURBT,combination treatment of BCG and chemotherapy after TURBT,treatment of carcinoma in situ,radical cystectomy,treatment of NMIBC recurrence,and follow-up and surveillance.We hope these recommendations can help promote the treatment and surveillance of NMIBC in China,especially for the primary medical institutions.

关键词： non-muscle invasive bladder cancer bladder cancer Transurethral resection of bladder tumor Treatment Surveillance Guideline

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Intravesical bacillus Calmette-Guerin(BCG)in treating non-muscle invasive bladder cancer—analysis of adverse effects and effectiveness of two strains of BCG(Danish 1331 and Moscow-I)

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Asian Journal of Urology 2022年第2期9卷 157-164页

作者： Yuvaraja B.Thyavihally Preetham Dev Santosh Waigankar Abhinav Pednekar Nevitha Athikari Abhijit Raut Archan Khandekar Naresh Badlani Ashishkumar Asari Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute Andheri WestMumbaiIndia

Objective:To compare the differences in adverse effects and efficacy profile between bacillus Calmette-Guerin(BCG)Danish 1331 and BCG Moscow-I strain in management of non-muscle invasive bladder cancer.Methods:Clinical data of 188 cases of non-muscle invasive bladder cancer treated with BCG between January 2008 and December 2018 in our institute were collected prospectively and analysed retrospectively,and 114 patients who completed a minimum of 12 months of follow-up were analysed.Patient and tumor characteristics,strain of BCG,adverse effects,and tumor progression were included for analysis.Intravesical BCG was instilled in intermediate-and high-risk patients.Six weeks of induction BCG,followed by three weekly maintenance BCG at 3,6,12,18,and 24 months was advised in high-risk patients.Results:Overall 68 patients received BCG Danish 1331 strain and 46 patients received Moscow-I strain.Patient and tumor characteristics were well balanced between the two groups.The median follow-up period was 42.5 months and 34.5 months in Danish 1331 and Moscow-I groups,respectively.Adverse events like dropout rate,antitubercular treatment requirement,and need of cystectomy were higher in Moscow-I group(n=31,67.4%)when compared to Danish 1331 strain(n=33,48.5%)(p=0.046).On direct comparison between Danish 1331 and Moscow-I strain,there was similar 3-year recurrence-free survival(80.0%vs.72.9%)and 3-year progression-free survival(96.5%vs.97.8%).Conclusion:Study results suggest no significant differences between Danish 1331 and Moscow-I strain in recurrence-free survival and progression-free survival,but a significantly higher incidence of moderate to severe adverse events in BCG Moscow-I strain.

关键词： Adjuvant bacillus Calmette-Guerin Bacillus Calmette-Guerin adverse effects Danish 1331 strain Intravesical therapy Moscow-I strain non-muscle invasive bladder cancer

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Can intravesical bacillus Calmette-Guerin reduce recurrence in patients with non-muscle invasive bladder cancer？ An update and cumulative meta-analysis

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Frontiers of Medicine 2014年第2期8卷 241-249页

作者： Jiangang Pan Mo Liu Xing Zhou The Second Affiliated Hospital of Guangzhou Medical University Guangzhou 510260 China Sun Yat-sen Memorial Hospital Sun Yat-sen University Guangzhou 510120 China

Approximately 70% of newly diagnosed bladder tumors are non-muscle invasive bladder cancer （NMIBC）. NMIBC accounts for approximately 80% of total bladder cancer cases. Bacillus Calmette-Guerin （BCG） instillation and maintenance is considered as the standard adjuvant treatment for superficial bladder cancer. A number of randomized studies have focused on the benefit of maintenance therapy following initial BCG induction. To provide further insights into the effect of intravesical instillation on recurrence in patients with NMIBC, we analyzed this relationship by conducting an updated detailed meta-analysis. Evidence suggested that adjuvant intravesical BCG with maintenance treatment is significantly effective for the prophylaxis of tumor recurrence in patients with NMIBC.

关键词： non-muscle invasive bladder cancer bacillus Calmette-Guerin （BCG） meta-analysis

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Did the Scientific Innovations in the Management of non-muscle invasive bladder cancer Patients Improve the Outcome during the Last 2 Decades?

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Open Journal of Urology 2022年第11期12卷 563-587页

作者： Walid F. Alame Nehme Raad Serge Ibrahim Division of Urology Sahel General Hospital-FAUMC Beirut Lebanon Department of Urology Mouwasat Hospital Dammam Saudi Arabia Urology Resident Faculty of Medicine Lebanese University Beirut Lebanon

Objectives: Previous reviews reported the outcome of each scientific modality in the management of T1 high-grade bladder cancer. The objective of this review is to assess and evaluate the available scientific modalities used during the last two decades and determine whether they were able to improve the clinical outcome. Literature Search Methodology: A systematic literature review was conducted from 2000-2020 using PubMed, Medline, Embase, and other database sites looking at randomized controlled trials (RCTs), clinical trials, research, review articles, and original articles addressing the different scientific modalities used to diagnose and manage patients with non-muscle invasive bladder cancer (NMIBC)during the last 2 decades. More than 573 studies were retrieved following the preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines and PICOS criteria (Population, Intervention, Comparators, Outcomes, and Study design). Only 85 articles were selected for review including 19 prospective trials, 44 RCTs, original articles, research articles, one review article, and clinical trials—Retrospective studies were excluded to limit bias as much as possible in the analysis. Results: Randomized controlled trials (RCTs) have become the gold standard for evaluating the efficacy of new treatments. They are considered the highest standard of evidence-based medicine and are the method of choice. Overall, we selected 85 studies for review, among them 63 prospective trials and RCTs, with a total of 21,895 patients, published between 2000 and 2020. Previously conducted studies have shown that identifying rare histological types with poor prognoses can help improve outcomes, mainly the plasmacytoid type. Many articles addressed the role of biomarkers in the early identification of patients with NMIBC for recurrence and progression—P-cadherin expression and others were used to predict recurrence and/or progression with promising results. Despite the need for modifications, risk stratification is an i

关键词： non-muscle invasive bladder cancer Outcome Early Cystectomy Biomarkers Intravesical Agents Re-TURBT Histology Risk Stratification

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Molecular mechanisms and novel therapeutic strategies of BCG-unresponsive non-muscle invasive bladder cancer: Emerging immunotherapy has become a new choice?

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Journal of Hainan Medical University 2020年第14期26卷 58-62页

作者： Xin-Ming Hu Lei Xu Jun Gu Hua-Lei Chen Ting-Ming Wu Shen Xu Xian-Ping Che 海南医学院第二附属医院泌尿外科海南海口571000

Objective:THigh-risk non-invasive bladder cancer(NMIBC)has a high rate of recurrence and disease progression.At present,there are still insufficient effective prevention and treatment methods,especially for patients who have failed BCG treatment.This article reviews the research progress of the molecular mechanism of BCG unresponsive NMIBC,and summarizes the current status and prospects of emerging therapeutic strategies represented by immunotherapy,providing a theoretical basis for the immunotherapy of BCG non-reactive NMIBC.Methods:We searched the PubMed and CNKI journal full-text database search system for keywords"non-muscle invasive bladder cancer,BCG unresponsive,disease recurrence,disease progression,and immunotherapy"with 126 English and 538 Chinese articles.The literature,as well as the relevant clinical research in ClinicalTrials.gov,were integrated together to obtain the results.Results:Immunotherapy was performed in various types of tumors,and the use of immunotherapeutic drugs with different oncotargets administered alone,sequentially or in combination for the treatment of BCG-unresponsive NMIBC have achieved favorable effects,and more Clinical research is still ongoing.Conclusion:Immunotherapy is currently the most promising treatment for cancer,and it is indispensable for patients with NMIBC,both biologically and clinically.We look forward to more laboratory and clinical research in immunotherapy in the future.

关键词： BCG unresponsive non-muscle invasive bladder cancer Disease progression Immunotherapy

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A Th2-score in the tumor microenvironment as a predictive biomarker of response to Bacillus Calmette Guérin in patients with non-muscle invasive bladder carcinoma:A retrospective study

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Oncology Research 2023年第2期31卷 207-220页

作者： GUSTAVO MARTÍN VILLOLDO MARÍA TERESA POMBO MARIANA ARIS JOAQUÍN CHEMI PABLO MANDÓ SUPRIYA NAGARAJU JUAN CAMEAN ADRIÁN BURIONI DEBORAH EGEA MORA AMAT JOSÉLEÓN MELLADO JOSÉMORDOH ALBERTO VILLARONGA MARÍA MARCELA BARRIO Urology Department Instituto Alexander FlemingCiudad Autónoma de Buenos Aires1426Argentina Immunohistochemistry Department Instituto Alexander FlemingCiudad Autónoma de Buenos Aires1426Argentina Centro de Investigaciones Oncológicas Fundación Cáncer FUCACiudad Autónoma de Buenos Aires1426Argentina Urology Department MD Anderson Cancer CenterHoustonTX77030USA Pathology Department Instituto Alexander FlemingCiudad Autónoma de Buenos Aires1426Argentina

Intravesical Bacillus Calmette Guerin(BCG)is the gold standard therapy for intermediate/high-risk nonmuscle invasive bladder cancer(NMIBC).However,the response rate is~60%,and 50%of non-responders will progress to muscle-invasive disease.BCG induces massive local infiltration of inflammatory cells(Th1)and ultimately cytotoxic tumor elimination.We searched for predictive biomarker of BCG response by analyzing tumor-infiltrating lymphocyte(TIL)polarization in the tumor microenvironment(TME)in pre-treatment biopsies.Pre-treatment biopsies from patients with NMIBC who received adequate intravesical instillation of BCG(n=32)were evaluated retrospectively by immunohistochemistry.TME polarization was assessed by quantifying the T-Bet+(Th1)and GATA-3+(Th2)lymphocyte ratio(G/T),and the density and degranulation of EPX+eosinophils.In addition,PD-1/PD-L1 staining was quantified.The results correlated with BCG response.In most non-responders,Th1/Th2 markers were compared in pre-and post-BCG biopsies.ORR was 65.6%in the study population.BCG responders had a higher G/T ratio and a greater number of degranulated EPX+cells.Variables combined into a Th2-score showed a significant association with higher scores in responders(p=0.027).A Th2-score cut-off value>48.1 allowed discrimination of responders with 91%sensitivity but lower specificity.Relapse-free survival was significantly associated with the Th2-score(p=0.007).In post-BCG biopsies from recurring patients,TILs increased Th2-polarization,probably reflecting BCG failure to induce a pro-inflammatory status and,thus,a lack of response.PD-L1/PD-1 expression was not associated with the response to BCG.Our results support the hypothesis that a preexisting Th2-polarized TME predicts a better response to BCG,assuming a reversion to Th1 polarization and antitumor activity.

关键词： non-muscle invasive bladder cancer BCG predictive biomarkers Lymphocyte polarization

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Narrow band imaging for bladder cancer

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Asian Journal of Urology 2016年第3期3卷 126-129页

作者： Thomas Y.Hsueh Allen W.Chiu Division of Urology Department of SurgeryTaipei City Hospital Renai BranchTaipei Department of Urology School of MedicineNational Yang-Ming UniversityTaipei

Narrow band imaging(NBI)is a newly developed technology aiming to provide additional endoscopic information for patients with bladder cancer.This review focuses on the diagnostic accuracy and treatment outcome using NBI cystoscopy for the treatment of nonmuscle invasive bladder cancer.Current results showed improved sensitivity of NBI cystoscopy compared to conventional white light cystoscopy,although lower specificity and increased false-positive results were reported using NBI cystoscopy.The treatment outcome using NBI technology in transurethral resection of bladder tumor had a positive impact while decreased number of residual tumors and tumor recurrence at follow-up were reported.In the future,the application of NBI technology might refine the treatment and follow-up protocol in patients with non-muscle invasive bladder cancer.However,this large scale prospective studies are required to confirm the real cost-effectiveness of this new technology.

关键词： non-muscle invasive bladder cancer Narrow band imaging Diagnosis Treatment

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