Carcinomes urothéliaux Des Voies excrétrices supérieures traitées en Vie réelle Par immunothérapie (VESUVIO) : étude rétrospective Nationale
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Urothelial Carcinoma
- Sponsor
- Assistance Publique - Hôpitaux de Paris
- Enrollment
- 350
- Primary Endpoint
- Overall survival on anti-PD-(L)1 immunotherapy
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
Upper-tract urothelial carcinoma (UTUC) is a rare tumor. Standard treatment of localized disease is most often radical nephroureterectomy.
In advanced/metastatic disease, treatments follow the standards for urothelial carcinoma including platinum-based chemotherapy and anti-PD(L)1 (Programmed death (ligand) 1) immunotherapy, with no regard as to the primary disease site (bladder or upper tract). Given the rarity of UTUC, efficacy data in the UTUC subgroup of advanced urothelial carcinoma is scarce.
UTUC show distinct pahological and molecular features, including higher prevalence of microsatellite instability and of abnormalities in the FGFR (fibroblast growth factor receptors) gene family. These specific features may impact outcomes of immunotherapy in advanced/metastatic UTUC.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 18 and more
- •Diagnosis of urothelial carcinoma (with or without variant histology)
- •Advanced/metastatic disease not amenable to local treatment with curative intent
- •Treatment with an anti-PD-(L)1 monoclonal antibody initiated between 2016 and 2022
Exclusion Criteria
- •Patient's opposition to this research
- •Urothelial carcinoma of bladder or urethral primary site
- •Non-urothelial tumor
- •Maintenance immunotherapy initiated without disease progression
Outcomes
Primary Outcomes
Overall survival on anti-PD-(L)1 immunotherapy
Time Frame: 2 years after immunotherapy initiation
Secondary Outcomes
- Translational study of predictive biomarkers of efficacy(Up to 7 years after immunotherapy initiation)
- Reasons for treatment discontinuation(Up to 7 years after immunotherapy initiation)
- Overall survival(5 years after immunotherapy initiation)
- Progression free survival(3 years after immunotherapy initiation)
- Best Objective Radiologic Response(Up to 7 years maximum)
- Duration of immunotherapy treatment(Up to 7 years after immunotherapy initiation)