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.
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.
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.
The IBCG consensus recommendations provide practical guidance on BST for BCG-U NMIBC.
European urology. 2024 Aug 24 [Epub ahead of print]
Roger Li, Patrick J Hensley, Shilpa Gupta, Hikmat Al-Ahmadie, Marko Babjuk, Peter C Black, Maurizio Brausi, Kelly K Bree, Mario I Fernández, Charles C Guo, Amir Horowitz, Donald L Lamm, Seth P Lerner, Yair Lotan, Paramananthan Mariappan, David McConkey, Laura S Mertens, Carmen Mir, Jeffrey S Ross, Michael O'Donnell, Joan Palou, Kamal Pohar, Gary Steinberg, Mark Soloway, Philippe E Spiess, Robert S Svatek, Wei Shen Tan, Rikiya Taoka, Roger Buckley, Ashish M Kamat
Department of Genitourinary Oncology, H. Lee Moffitt Cancer Center, Tampa, FL, USA., Department of Urology, University of Kentucky College of Medicine, Lexington, KY, USA., Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH, USA., Department of Pathology and Laboratory Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA., Department of Urology, Second Faculty of Medicine of Charles University, University Hospital Motol, Prague, Czechia., Department of Urologic Sciences, University of British Columbia, Vancouver, Canada., Department of Urology, Hesperia Hospital, Modena, Italy., Department of Urology, University of Texas MD Anderson Cancer Center, Houston, TX, USA., Department of Urology, Clinica Alemana Universidad del Desarrollo, Santiago, Chile., Department of Genitourinary Pathology, University of Texas MD Anderson Cancer Center, Houston, TX, USA., Departments of Immunology & Immunotherapy and Oncological Sciences, Lipschultz Precision Immunology Institute and The Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA., BCG Oncology PC, University of Arizona College of Medicine, Phoenix, AZ. USA., Scott Department of Urology, Dan L. Duncan Cancer Center, Baylor College of Medicine, Houston, TX, USA., Department of Urology, UT Southwestern Medical Center, Dallas, TV, USA., Edinburgh Bladder Cancer Surgery, University of Edinburgh, Department of Urology, Western General Hospital, Edinburgh, UK., Johns Hopkins Greenberg Bladder Cancer Institute, Baltimore, MD, USA., Netherlands Cancer Institute, Antoni Van Leeuwenhoek Hospital, Amsterdam, The Netherlands., Department of Urology, Hospital Universitario La Ribera, Valencia, Spain., Upstate Medical University, Syracuse, NY, USA; Foundation Medicine, Boston, MA USA., Carver College of Medicine, University of Iowa, Iowa City, IA, USA., Department of Urology, Fundació Puigvert, Universitat Autònoma de Barcelona, Barcelona, Spain., Department of Urology, Ohio State University, Columbus, OH, USA., Department of Urology, Rush University Medical Center, Chicago, IL, USA., Memorial Hospital, Hollywood, FL, USA., Moffitt Cancer Center, Morsani College of Medicine, University of South Florida Tampa, FL, USA., Department of Urology, University of Texas Health San Antonio, San Antonio, TX, USA., Faculty of Medicine, Kagawa University, Kagawa, Japan., North York General Hospital, Toronto, Canada., Department of Urology, University of Texas MD Anderson Cancer Center, Houston, TX, USA. Electronic address: .