Bladder-sparing Therapy for Bacillus Calmette-Guerin-unresponsive Non-muscle-invasive Bladder Cancer: International Bladder Cancer Group Recommendations for Optimal Sequencing and Patient Selection

Roger Li; Patrick J. Hensley; Shilpa Gupta; Hikmat Al-Ahmadie; Marko Babjuk; Peter C. Black; Maurizio Brausi; Kelly K. Bree; Mario I. Fernandez; 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

doi:10.1016/j.eururo.2024.08.001

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Bladder-sparing Therapy for Bacillus Calmette-Guerin-unresponsive Non-muscle-invasive Bladder Cancer: International Bladder Cancer Group Recommendations for Optimal Sequencing and Patient Selection

Journal article

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Bladder-sparing Therapy for Bacillus Calmette-Guerin-unresponsive Non-muscle-invasive Bladder Cancer: International Bladder Cancer Group Recommendations for Optimal Sequencing and Patient Selection

Roger Li, Patrick J. Hensley, Shilpa Gupta, Hikmat Al-Ahmadie, Marko Babjuk, Peter C. Black, Maurizio Brausi, Kelly K. Bree, Mario I. Fernandez, Charles C. Guo, …

European urology, Vol.86(6), pp.516-527

12/01/2024

DOI: 10.1016/j.eururo.2024.08.001

PMID: 39183090

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Abstract

Background and objective: There has been a recent surge in the development of agents for bacillus Calmette-Guerin-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. (c) 2024 European Association of Urology. Published by Elsevier B.V. All rights are reserved, including those for text and data mining, AI training, and similar technologies.

Life Sciences & Biomedicine

Science & Technology

Urology & Nephrology

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Title: Subtitle: Bladder-sparing Therapy for Bacillus Calmette-Guerin-unresponsive Non-muscle-invasive Bladder Cancer: International Bladder Cancer Group Recommendations for Optimal Sequencing and Patient Selection
Creators: Roger Li - Moffitt Cancer Center
Patrick J. Hensley - University of Kentucky
Shilpa Gupta - Cleveland Clinic
Hikmat Al-Ahmadie - Memorial Sloan Kettering Cancer Center
Marko Babjuk - Charles University
Peter C. Black - University of British Columbia
Maurizio Brausi - Hesperia Hospital
Kelly K. Bree - The University of Texas MD Anderson Cancer Center
Mario I. Fernandez - Universidad del Desarrollo
Charles C. Guo - The University of Texas MD Anderson Cancer Center
Amir Horowitz - Tisch Hospital
Donald L. Lamm - University of Arizona
Seth P. Lerner - Baylor College of Medicine
Yair Lotan - Southwestern Medical Center
Paramananthan Mariappan - Western General Hospital
David McConkey - Bladder Cancer Advocacy Network
Laura S. Mertens - The Netherlands Cancer Institute
Carmen Mir - Hospital de La Ribera
Jeffrey S. Ross - SUNY Upstate Medical University
Michael O'Donnell - Univ Iowa, Carver Coll Med, Iowa City, IA USA
Joan Palou - Puigvert Foundation
Kamal Pohar - The Ohio State University
Gary Steinberg - Rush University Medical Center
Mark Soloway - Memorial Hospital
Philippe E. Spiess - University of South Florida
Robert S. Svatek - The University of Texas Health Science Center at San Antonio
Wei Shen Tan - The University of Texas MD Anderson Cancer Center
Rikiya Taoka - Kagawa University
Roger Buckley - North York General Hospital
Ashish M. Kamat - The University of Texas MD Anderson Cancer Center
Resource Type: Journal article
Publication Details: European urology, Vol.86(6), pp.516-527
DOI: 10.1016/j.eururo.2024.08.001
PMID: 39183090
NLM abbreviation: Eur Urol
ISSN: 0302-2838
eISSN: 1873-7560
Publisher: Elsevier
Number of pages: 12
Grant note: AstraZeneca EnGene Ferring; Ferring Pharmaceuticals Merck; Merck & Company Medac
Language: English
Date published: 12/01/2024
Academic Unit: Urology
Record Identifier: 9984792364502771

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