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.