New relevant references have been identified through a structured assessment of the literature and incorporated in the various chapters of the 2022 EAU MIBC Guidelines resulting in new sections and additional or revised recommendations including:
- Section 5.2 Imaging for staging of MIBC, and in particular Section 5.2.1 Local staging of MIBC, with the provision of a revised recommendation.
5.2.6 Summary of evidence and guidelines for staging in muscle-invasive bladder cancer
Summary of evidence | LE |
In local staging, MRI is superior to CT in terms of differentiating T1 from T2 disease. | 2b |
Recommendation | Strength rating |
Use CT urography unless it is contraindicated for reasons related to contrast administration or radiation dose, in that case use MRI. | Strong
|
Considerable new data was added to:
- Section 7.1 Neoadjuvant therapy
- Section 7.1.2 Role of cisplatin-based chemotherapy; this section was revised with considerable new data added.
- Section 7.3.5 Laparoscopic/robotic-assisted laparoscopic cystectomy; a new section on stricture formation has been included.
- Section 7.3.6.2 Different types of urinary diversion, in particular Section 7.3.6.2.1 Uretero-cutaneostomy
- Section 7.6.2 Role of adjuvant immunotherapy has been completely revised including a new recommendation.
7.6.3 Summary of evidence and guidelines for adjuvant therapy
Summary of evidence | LE |
Adjuvant cisplatin-based chemotherapy for high-risk patients (pT3, 4 and/or or N+ M0) without neoadjuvant treatment can be associated with improvement in DFS and OS but trials are underpowered to adequately answer this question. | 2a
|
To date, studies of immune checkpoint inhibitors in the adjuvant setting for patients with high-risk MIBC who have and have not received neoadjuvant chemotherapy have demonstrated conflicting results with the CheckMate 274 study demonstrating an improvement in DFS with adjuvant nivolumab and the IMvigor 010 study failing to show an improvement in DFS with adjuvant atezolizumab. | 1b
|
Results for adjuvant treatment with immune-checkpoint inhibitors in high-risk MIBC are conflicting: nivolumab improved DFS (Checkmate 274) whereas atezolizumab did not (IMvigor 010). | 1b
|
Circulating tumour DNA holds promise as both a prognostic and predictive biomarker to guide the use of adjuvant IO for UC in patients who are at a high risk of recurrence and positive for ctDNA treated with adjuvant atezolizumab demonstrating improved outcomes compared with observation. | 2b
|
Recommendation | Strength rating |
Discuss immunotherapy with nivolumab with selected patients with pT3/4 and/or pN+ disease not eligible for, or who declined, adjuvant cisplatin-based chemotherapy. | Weak
|
- Section 7.7 Metastatic disease was completely revised, resulting in the inclusion of new recommendation.
7.7.9 Summary of evidence and guidelines for metastatic disease
Summary of evidence | LE |
Enfortumab vedotin after prior platinum chemotherapy and checkpoint inhibitor immunotherapy has demonstrated a significant survival benefit as compared to chemotherapy. | 1b
|
PD-L1 inhibitor atezolizumab is approved for patients with advanced or metastatic UC unfit for cisplatin-based chemotherapy in case of high PD-1 expression defined as tumour-infiltrating immune cells covering > 5% of the tumour area using the SP142 assay. | 1b
|
PD-1 inhibitor pembrolizumab is approved for patients with advanced or metastatic UC unfit for any platinum-based chemotherapy in case of high PD-1 expression defined as CPS of > 10 using the Dako 22C33 platform (EMA; FDA approval independent of PD-1 status). | 1b
|
Recommendation | Strength rating |
Evaluate for FGFR2/3 genetic alterations for the potential use of erdafitinib in patients with locally advanced or metastatic urothelial carcinoma who have progressed following platinum-containing chemotherapy (including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy). | Weak
|