BACKGROUND AND OBJECTIVE: There has been a recent surge in the development of agents for bacillus Calmette-Guérin-unresponsive (BCG-U) non-muscle-invasive bladder cancer (NMIBC). Critical assessment of these agents and practical recommendations for optimal selection of patients and therapies are urgently needed, especially in the absence of randomized trials on bladder-sparing treatment (BST) options. METHODS: A global committee of bladder cancer experts was assembled to develop recommendations on BST for BCG-U NMIBC. Working groups reviewed the literature and developed draft recommendations, which were then voted on by International Bladder Cancer Group (IBCG) members using a modified Delphi process. During a live meeting in August 2023, voting results and supporting evidence were presented, and recommendations were refined on the basis of meeting discussions. Final recommendations achieved >75% agreement during the meeting, and some were further refined via web conferences and e-mail discussions. KEY FINDINGS AND LIMITATIONS: There is currently no single optimal agent for patients with BCG-U disease who seek to avoid radical cystectomy (RC). BST selection should be personalized, taking into account individual patient characteristics and preferences, tumor attributes, and efficacy/toxicity data for the agents available. For patients with BCG-U carcinoma in situ (CIS), gemcitabine/docetaxel (GEM/DOCE), nadofaragene firadenovec (NFF), and nogapendekin alfa inbakicept-pmln (NAI) + BCG are recommended; because of its systemic toxicity, pembrolizumab should only be offered after other options are exhausted. For patients with BCG-U papillary-only tumors, GEM/DOCE, NFF, NAI + BCG, single-agent chemotherapy, hyperthermic mitomycin C, and pembrolizumab are recommended. Given the modest efficacy of available options, clinical trial participation is encouraged. For unapproved agents with reported data, IBCG recommendations await the final results of pivotal trials. CONCLUSIONS AND CLINICAL IMPLICATIONS: The IBCG consensus recommendations provide practical guidance on BST for BCG-U NMIBC.

BCG Oncology PC University of Arizona College of Medicine Phoenix AZ USA

Carver College of Medicine University of Iowa Iowa City IA USA

Department of Genitourinary Oncology H Lee Moffitt Cancer Center Tampa FL USA

Department of Genitourinary Pathology University of Texas MD Anderson Cancer Center Houston TX USA

Department of Pathology and Laboratory Medicine Memorial Sloan Kettering Cancer Center New York NY USA

Department of Urologic Sciences University of British Columbia Vancouver Canada

Department of Urology 2nd Faculty of Medicine of Charles University University Hospital Motol Prague Czechia

Department of Urology Clinica Alemana Universidad del Desarrollo Santiago Chile

Department of Urology Fundació Puigvert Universitat Autònoma de Barcelona Barcelona Spain

Department of Urology Hesperia Hospital Modena Italy

Department of Urology Hospital Universitario La Ribera Valencia Spain

Department of Urology Ohio State University Columbus OH USA

Department of Urology Rush University Medical Center Chicago IL USA

Department of Urology University of Kentucky College of Medicine Lexington KY USA

Department of Urology University of Texas Health San Antonio San Antonio TX USA

Department of Urology University of Texas MD Anderson Cancer Center Houston TX USA

Department of Urology UT Southwestern Medical Center Dallas TV USA

Departments of Immunology and Immunotherapy and Oncological Sciences Lipschultz Precision Immunology Institute and The Tisch Cancer Institute Icahn School of Medicine at Mount Sinai New York NY USA

Edinburgh Bladder Cancer Surgery University of Edinburgh Department of Urology Western General Hospital Edinburgh UK

Faculty of Medicine Kagawa University Kagawa Japan

Johns Hopkins Greenberg Bladder Cancer Institute Baltimore MD USA

Memorial Hospital Hollywood FL USA

Moffitt Cancer Center Morsani College of Medicine University of South Florida Tampa FL USA

Netherlands Cancer Institute Antoni Van Leeuwenhoek Hospital Amsterdam The Netherlands

North York General Hospital Toronto Canada

Scott Department of Urology Dan L Duncan Cancer Center Baylor College of Medicine Houston TX USA

Taussig Cancer Institute Cleveland Clinic Cleveland OH USA

Upstate Medical University Syracuse NY USA; Foundation Medicine Boston MA USA

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