Guidelines

Muscle-invasive and Metastatic Bladder Cancer

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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 tumours [1], non-muscle-invasive bladder cancer (TaT1 and carcinoma in situ) (NMIBC) [2] and primary urethral carcinomas (PUC) [3].

It must be emphasised that clinical guidelines present the best evidence available to the experts but following Guidelines 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 preferences/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 on MIBC is an international, multidisciplinary group of clinicians, including urologists, oncologists, a pathologist, a radiologist, a radiotherapist and two patient representatives. Section 6.2 on 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 reference document is an abridged version that may require consultation together with the full text version. Several scientific publications are available, the latest dating to 2025 [4]. All documents are accessible through the EAU website Uroweb: https://uroweb.org/guidelines/muscle-invasive-and-metastatic-bladder-cancer. 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 MIBC 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. These 2026 MIBC Guidelines present a comprehensive update of the 2025 publication.

1.4.2. Summary of changes

For the 2026 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:

  • The Guidelines were restructured to follow the patient journey and illustrate real-world clinical pathways.
  • Further data from the NIAGARA study was added, including that the perioperative regimen of cisplatin/gemcitabine and durvalumab has been approved by the European Medicines Agency (EMA) in July 2025, and it is also United States Food and Drug Administration (FDA) approved.
  • The recently published results from the IMvigor011 trial evaluating the efficacy of atezolizumab as adjuvant therapy versus a placebo in patients with high-risk MIBC who are circulating tumour deoxyribonucleic acid (ctDNA) positive following cystectomy was added.
  • The results from the phase III KEYNOTE-905/EV-303 study evaluating perioperative enfortumab vedotin plus pembrolizumab (EV + P) in patients with cisplatin-ineligible MIBC.
  • Further data of extended follow-up from three phase III randomised controlled trials (RCTs) were included. The interim overall survival (OS) data reported a promising trend in favour of nivolumab.
  • An RCT was included that reported on functional outcomes of robot-assisted radical cystectomy (RARC) with intracorporeal urinary diversion (ICUD) padua neobladder.
  • A systematic review and meta-analysis was included that found that 90-day mortality was 11% in patients aged ≥ 80 years, compared to 2% for patients aged < 80 years.
  • The withdrawal of the accelerated FDA approval indication for Sacituzumab govitecan was addressed, as the TROPiCS-04 trial reported that it did not significantly improve OS or progression-free survival (PFS) compared with physician’s choice of chemotherapy.
  • A systematic review and meta-analysis of metastasis-directed therapy was included, showing long-term survival after surgical metastasectomy in metastatic urothelial carcinoma.
  • Statistics on mental health disorders after bladder cancer diagnosis have been included. Clinicians should monitor mental health post-MIBC surgery, refer to specialist support when needed, and inform patients of peer support options.
  • The following new recommendations were included in Chapters 4, 6 and 10:
    • Determine immunohistochemical human epidermal growth factor receptor (HER) 2 expression to select patients for HER2-directed antibody-drug conjugate therapy.
    • Offer antibody-drug conjugate Trastuzumab deruxtecan in case of HER2 over expression (IHC 3+) and consider in case of HER2 (IHC 2+).
    • Offer perioperative chemo-immunotherapy with cisplatin/gemcitabine and durvalumab to patients with MIBC (T2-T4a, cN0 M0) who are eligible for cisplatin-based chemotherapy (GFR > 40mL/min.allowed) and immunotherapy.