Table 3.
SOGUG-SEOM Recommendations for localized muscle-invasive and advanced urothelial bladder cancer
LE; GoR | |
---|---|
Locoregional disease | |
Radical cystectomy | |
RC with pelvic LND is the standard treatment of MIBC cT2-T4aN0M0 | IA |
Removal of at least ten lymph nodes is recommended for a correct evaluation of lymph node status |
IVA |
Bladder preservation strategies | |
In experienced centers a TMT bladder-preserving therapy for MIBC is a reasonable alternative to cystectomy for selected patients who wish to avoid or do not tolerate radical cystectomy | IIB |
Radiosensitizing regimens as cisplatin or the combination of 5-FU plus mitomycin C are generally recommended | IIB |
Other regimens as cisplatin plus 5-FU, cisplatin plus paclitaxel and low-dose gemcitabine are established alternatives | IIB |
Other approaches such as TURBT alone, TURBT followed by chemotherapy or TURBT followed by RT are options for patients who cannot tolerate TMT | IIB |
Neoadjuvant treatment | |
Neoadjuvant cisplatin-based chemotherapy is recommended for patients with T2-4a bladder cancer | IA |
Adjuvant treatment | |
Adjuvant cisplatin-based chemotherapy is recommended in patients with pT3/4 and or pN + disease after RC if no neoadjuvant chemotherapy has been given and who have no contraindication for cisplatin | IA |
Follow-up | |
Follow-up after MIBC should be individualized and adapted to the risk of recurrence. Urine cytology and a CT scan should be done every 3–6 months for at least 3 years, and annually thereafter, with urethral washing and cystoscopy in selected cases | VA |
Advanced/metastastic disease | |
First-line systemic treatment | |
Cisplatin-based chemotherapy is considered the standard option for first-line metastatic UC. CG is preferred over MVAC and ddMVAC due to its better safety profile | IA |
For unfit patients, GCa should be the preferred first-line treatment option | IA |
According to the EMA label, pembrolizumab or atezolizumab could be an option in cisplatin ineligible patients with high PD-L1 expression levels | IIIB |
Immune checkpoint inhibitors and chemotherapy as maintenance or second-line | |
Maintenance therapy with avelumab is the standard of care for patients whose disease respond or did not progress after four to six cycles of first-line platinum-based chemotherapy (CG or CaG) | IA |
After progression to a first-line platinum-based therapy, PD-1/PD-L1 inhibitors are standard options | |
Pembrolizumab | IA |
Atezolizumab | IIIB |
Treatment with vinflunine is an alternative for patients in whom anti PD-1/PD-L1 therapy is not possible | IIB |
Treatment after failure to chemotherapy and immune checkpoint inhibitors | |
For patients progressing after platinum-containing chemotherapy and CPI, enfortumab-vedotin is recommended as standard treatment | IA |
For patients progressing after platinum-containing chemotherapy with or without previous CPI, with tumor harboring FGFR mutations or fusions, erdafitinib could be considered | IIIB |
Early supportive care is strongly recommended | VA |
LE level of evidence; GoR grade of recommendation. RC radical cystectomy. 5FU 5-fluorouracil. LND lymphadenectomy. MIBC muscle-invasive bladder cancer. TMT Trimodal therapy. TURBT transurethral resection of bladder tumor. CG Cisplatin-Gemcitabin. CaG carboplatin-Gemcitabine. PD-1/PD-L1 Programmed Death-1/ Programmed Death-ligand 1. CPI check-point inhibitors. FGFR fibroblast growth factor receptor