Intermediate-risk Non-muscle-invasive Bladder Cancer: Recommendations for Definitions, Risk Stratification, Management Strategies, and Clinical Trial Design from the International Bladder Cancer Group.

Intermediate-risk (IR) non-muscle-invasive bladder cancer (NMIBC) is a heterogeneous disease, and standardized definitions and risk-guided management are critical for appropriate patient care and clinical trial development.

A global committee of bladder cancer experts developed IR-NMIBC recommendations. Working groups reviewed literature and drafted recommendations, which were voted on by International Bladder Cancer Group (IBCG) members using a modified Delphi process. During an August 2024 meeting, voting results and evidence were presented, and recommendations were refined. Final recommendations achieved >75% agreement.

The IBCG recommends inclusion of only low-grade (LG; G1 and G2) tumors in the IR-NMIBC category, risk stratified using the IBCG IR-NMIBC risk scoring system. Given the relatively indolent course and treatment burden of IR-NMIBC, therapeutic deintensification with active surveillance or office-based ablation is appropriate for select patients. Morbidity related to transurethral resection of a bladder tumor can be mitigated by forgoing restaging resection in completely resected LG tumors and not mandating muscularis propria sampling. Perioperative chemotherapy reduces recurrences, and additional adjuvant intravesical treatment should be risk stratified. Clinical trials evaluating novel IR-NMIBC therapies, including adjuvant and ablative designs, should incorporate patient-reported outcomes and risk-stratified controls. Ablative trials, as proof-of-concept studies for efficacy, require randomized controlled studies in the adjuvant setting to confirm superiority over the standard of care.

The IBCG consensus recommendations provide practical guidance for clinical care and clinical trial design for patients with IR-NMIBC.

European urology oncology. 2025 Oct 10 [Epub ahead of print]

Roger Li, Patrick J Hensley, Marko Babjuk, Laura Bukavina, Sarah P Psutka, Seth P Lerner, Michael A O'Donnell, Yair Lotan, Kelly K Bree, Joan Palou Redorta, David J McConkey, Byron H Lee, Paramananthan Mariappan, Laura S Mertens, Mark S Soloway, Robert S Svatek, Wei Shen Tan, Stephen B Williams, Shilpa Gupta, Roger Buckley, Ashish M Kamat

Department of Genitourinary Oncology, Moffitt Cancer Center, Tampa, FL, USA., Department of Urology, University of Kentucky, Lexington, KY, USA., Department of Urology, Second Faculty of Medicine, Charles University, Hospital Motol, Prague, Czech Republic., Department of Urologic Oncology, Glickman Urologic Institute, Cleveland Clinic, Cleveland, OH, USA., Department of Urology, University of Washington Fred Hutchinson Cancer Center, Seattle, WA, USA., Department of Urology, Baylor College of Medicine, Houston, TX, USA., Department of Urology, University of Iowa Holden Comprehensive Cancer Center, Iowa City, IA, USA., Department of Urology, University of Texas Southwestern Medical Center, Dallas, TX, USA., Department of Urology, University of Texas MD Anderson Cancer Center, Houston, TX, USA., Department of Urology, Fundació Puigvert, Barcelona, Spain., Department of Urology, Johns Hopkins Greenberg Bladder Cancer Institute, Baltimore, MD, USA., Edinburgh Bladder Cancer Surgery, The University of Edinburgh Western General Hospital, Edinburgh, UK., Department of Urology, Netherlands Cancer Institute, Amsterdam, The Netherlands., Department of Urologic Oncology, Memorial Hospital, Hollywood, FL, USA., Division of Urologic Oncology, Department of Urology, University of Texas Health Science Center, San Antonio, TX, USA., Department of Urology, Yale School of Medicine, New Haven, CT, USA., Department of Surgery, Division of Urology, University of Texas Medical Branch, Galveston, TX, USA., Department of Genitourinary Oncology, Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH, USA., York General Hospital, Toronto, Canada., Department of Urology, University of Texas MD Anderson Cancer Center, Houston, TX, USA. Electronic address: .