Bladder-sparing therapy for bacillus Calmette-Guérin–unresponsive non–muscle-invasive bladder cancer: International Bladder Cancer Group recommendations for optimal sequencing and patient selection Review


Authors: Li, R.; Hensley, P. J.; Gupta, S.; Al-Ahmadie, H.; Babjuk, M.; Black, P. C.; Brausi, M.; Bree, K. K.; Fernández, M. I.; Guo, C. C.; Horowitz, A.; Lamm, D. L.; Lerner, S. P.; Lotan, Y.; Mariappan, P.; McConkey, D.; Mertens, L. S.; Mir, C.; Ross, J. S.; O'Donnell, M.; Palou, J.; Pohar, K.; Steinberg, G.; Soloway, M.; Spiess, P. E.; Svatek, R. S.; Tan, W. S.; Taoka, R.; Buckley, R.; Kamat, A. M.
Review Title: Bladder-sparing therapy for bacillus Calmette-Guérin–unresponsive non–muscle-invasive bladder cancer: International Bladder Cancer Group recommendations for optimal sequencing and patient selection
Abstract: 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. © 2024 European Association of Urology
Keywords: clinical trial; review; patient selection; gemcitabine; gene; bcg vaccine; consensus; practice guideline; pathology; bladder cancer; bladder tumor; urinary bladder neoplasms; docetaxel; fever; conservative treatment; carcinoma in situ; radical cystectomy; cystectomy; surgery; delphi study; immunological adjuvant; neoplasm invasiveness; drug administration; drug therapy; adjuvants, immunologic; mitomycin; therapy; bladder; tumor invasion; intravesical chemotherapy; immune checkpoint inhibitor; non muscle invasive bladder cancer; organ sparing treatments; humans; human; pembrolizumab; immune checkpoint inhibitors; web conferencing; non-muscle invasive bladder neoplasms; bacillus calmette-guérin–unresponsive non–muscle-invasive bladder cancer; bladder-sparing therapy; gemcitabine/docetaxel; gene-based therapy; nadofaragene firadenovec; nogapendekin alfa inbakicept-pmln; targeted treatments; inbakicept; nogapendekin alfa
Journal Title: European Urology
Volume: 86
Issue: 6
ISSN: 0302-2838
Publisher: Elsevier Science, Inc.  
Date Published: 2024-12-01
Start Page: 516
End Page: 527
Language: English
DOI: 10.1016/j.eururo.2024.08.001
PUBMED: 39183090
PROVIDER: scopus
DOI/URL:
Notes: Review -- Source: Scopus
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