Abstract
Radical cystectomy or nephroureterectomy with lymphadenectomy is the standard treatment for muscle-invasive urothelial carcinomas. Patients after curative surgery without clinically detectable metastases are at high risk of disease recurrence.
Neoadjuvant cisplatin-based chemotherapy provides the benefit of prolonging overall survival (OS) versus surgery alone. There is no clear treatment standard for patients with a high risk of recurrence after radical surgery.
Adjuvant cisplatin-based chemotherapy is often used (if not given neoadjuvantly). Some patients refuse chemotherapy or are unable to undergo it.
The efficacy and safety of treatment with checkpoint inhibitors PD-1/PD-L1 has been confirmed in the treatment of metastatic urothelial carcinoma. Adjuvant treatment with nivolumab in the CheckMate 274 clinical trial in patients with high-risk invasive urothelial carcinoma who underwent radical surgery resulted in a significant prolongation of disease-free time (DFS) in the ITT population and in the subgroup with PD-L1 expression >=1 %.
In the IMvigor010 trial, treatment with atezolizumab did not demonstrate efficacy in prolonging DFS compared to observation. The results of the two studies are thus contradictory.
Adjuvant treatment with checkpoint inhibitors in patients with non-metastatic urothelial carcinoma after radical surgical treatment with a high risk of recurrence is not yet standard.