1. INTRODUCTION
1.1. Aims and scope
This overview represents the updated European Association of Urology (EAU) Guidelines for Muscle-invasive and Metastatic Bladder Cancer (MIBC). The aim is to provide practical recommendations on the clinical management of MIBC. Separate EAU guidelines are available addressing upper urinary tract (UUT) tumours [1], non-muscle-invasive bladder cancer (TaT1 and carcinoma in situ) (NMIBC) [2], and primary urethral carcinomas [3].
It must be emphasised that clinical guidelines present the best evidence available to the experts, but following guideline recommendations will not necessarily result in the best outcome. Guidelines can never replace clinical expertise when making treatment decisions for individual patients, but rather help to focus decisions - also taking personal values and references/individual circumstances of patients into account. Guidelines are not mandates and do not purport to be a legal standard of care.
1.2. Panel composition
The EAU Guidelines Panel consists of an international multidisciplinary group of clinicians, including urologists, oncologists, a pathologist, a radiologist, radiotherapists and a patient representative. Section 5.3 - MIBC and health status, was developed with the assistance of Prof.Dr. S. O’Hanlon, consultant geriatrician, International Society of Geriatric Oncology (SIOG) representative. All experts involved in the production of this document have submitted potential conflict of interest statements which can be viewed on the EAU website Uroweb: https://uroweb.org/guidelines/muscle-invasive-and-metastatic-bladder-cancer/panel.
1.3. Available publications
A quick reference document (Pocket Guidelines) is available. This is an abridged version which may require consultation together with the full text version. Several scientific publications are available, the latest dating to 2023 [4]. All documents are accessible through the EAU website: http://uroweb.org/guideline/bladder-cancer-muscle-invasive-and-metastatic/.
An EAU Guidelines App for iOS and Android devices is also available containing the Pocket Guidelines, interactive algorithms and calculators, clinical decision support tools, guidelines cheat sheets and links to the extended guidelines.
1.4. Publication history and summary of changes
1.4.1. Publication history
The EAU Guidelines on Muscle Invasive Bladder Cancer were first published in 2004. Standard procedure for EAU Guidelines includes an annual assessment of newly published literature in the field to guide future updates This 2025 MIBC Guidelines present a limited update of the 2024 publication.
1.4.2. Summary of changes
For the 2025 MIBC Guidelines new and relevant evidence was identified, collated and appraised through a structured assessment of the literature for all sections of the Guidelines. Key changes include:
- New summary of evidence and recommendation in section 6.5 for use of susceptible FGFR3 alterations to select patients with unresectable or metastatic urothelial carcinoma for treatment with erdafitinib.
- Significant adaption and update to the recommendations for pre- and post-operative radiotherapy in section 7.2.3.
- Significant adaption and update to the summary of evidence and recommendation in section 7.3.3.2.1 sexual-preserving techniques in women.
- New recommendation in section 7.3.10 related radical cystectomy and urinary diversion based on the results of the SWOG trial. In addition, the recommendation related to hospital volume in this section has been adapted.
- New recommendation in section 7.4.1 for salvage cystectomy after trimodality therapy.
- New recommendation in section 7.5.4.1 for management of all patients who are candidates for trimodality bladder-preserving treatment in a multidisciplinary team setting using a shared-decision making process.
- Significant adaption and update to the recommendation for adjuvant nivolumab in selected patients with pT3/4 and/or pN+ disease not eligible for, or who declined, adjuvant cisplatin-based chemotherapy in section 7.6.3. Upgraded strength rating.
- Update of the summary of evidence in section 7.7.9 and addition of a new recommendation for metastatic disease regarding antibody drug conjugate Trastuzumab deruxtecan in case of HER2 overexpression. In addition, the recommendations on Sacituzumab govitecan have been removed as the manufacturer has withdrawn FDA approval for this product.
- Update of section 8.1 follow-up for MIBC.
- Update of figures 7.1 and 7.2.