European Association of Urology Guidelines on Muscle-invasive and Metastatic Bladder Cancer: Summary of the 2025 Guidelines
- Study type
- Clinical guideline
- Study name
- EAU MIBC 2025
- Design
- Clinical guideline based on a structured review of the evidence (MEDLINE, EMBASE, Cochrane) with grading of recommendation strength (strong/weak)
- Source
- Eur Urol · 2025
In plain words
The European Association of Urology updates its guidelines every year for bladder cancer that has reached the muscle or spread. The main messages: treatment decisions should be made by a team of specialists (urologist, oncologist, radiation oncologist) together with the patient; when possible, cisplatin-based chemotherapy should be given before surgery to remove the bladder; three-part bladder-sparing treatment is a valid alternative for suitable patients; and in advanced disease, the combination of enfortumab vedotin and pembrolizumab is the preferred first treatment.
Key guideline recommendations
- Strong
If eligible for cisplatin-based chemotherapy, offer neoadjuvant cisplatin-based combination chemotherapy to patients with muscle-invasive bladder cancer (T2 to T4a, cN0 M0).
- Strong
Do not offer neoadjuvant cisplatin-containing combination chemotherapy to patients who are ineligible for cisplatin-based combination chemotherapy.
- Strong
Offer neoadjuvant immunotherapy with checkpoint inhibitors alone only within a clinical trial.
- Strong
Offer radical cystectomy to patients with T2 to T4a, N0M0 disease or very high-risk non-muscle-invasive bladder cancer. Do not delay cystectomy for more than 3 months unless the patient receives neoadjuvant chemotherapy. Lymph node dissection (standard template) is an integral part of cystectomy.
- Strong
Offer radical cystectomy or bladder-sparing trimodality therapy (TMT) as primary curative treatment options to eligible patients, as they are more effective than radiotherapy alone. Manage all TMT candidates in a multidisciplinary team, with the treatment choice made through shared decision-making; explain to TMT candidates that lifelong bladder surveillance is necessary.
- Strong
Offer adjuvant nivolumab to selected patients with pT3/4 and/or pN+ disease who are ineligible for or declined adjuvant cisplatin-based chemotherapy (FDA approval regardless of PD-L1 status; EMA approval only for tumour cell PD-L1 expression of 1% or more). Offer adjuvant cisplatin-based combination chemotherapy to patients with pT3/4 and/or pN+ disease who did not receive neoadjuvant chemotherapy.
- Strong
First-line treatment of metastatic disease in patients eligible for combination therapy: use the antibody–drug conjugate enfortumab vedotin with the checkpoint inhibitor pembrolizumab. If enfortumab vedotin is contraindicated or unavailable: platinum-containing combination chemotherapy (cisplatin or carboplatin with gemcitabine) followed by avelumab maintenance in patients with at least stable disease; and in cisplatin-eligible patients, consider cisplatin/gemcitabine with nivolumab.
- Strong
Use FGFR3 susceptible alterations to select patients with unresectable or metastatic urothelial carcinoma for treatment with erdafitinib. After platinum-containing chemotherapy ± checkpoint inhibitor: offer erdafitinib in case of targetable FGFR alterations and prior checkpoint inhibitor treatment.
Study population
Patients with muscle-invasive bladder cancer (MIBC) and metastatic urothelial cancer.
Clinical significance and place in guidelines
The EAU guideline is one of the main references for managing bladder cancer in Europe and many other countries. The recommendations below are taken from the full text of the 2025 guideline (limited update, March 2025), of which this paper is a summary. The 2026 version of the full guideline on the EAU website (uroweb.org) adds a new recommendation for perioperative chemoimmunotherapy with cisplatin/gemcitabine and durvalumab (the NIAGARA regimen).
Limitations
The published paper is a summary of the guideline; full details of the evidence and all recommendations are in the full guideline on the EAU website. The guideline is updated annually, and some newer data (such as NIAGARA, KEYNOTE-905 and EV-304) have been or will be included in later versions.
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.