Immunotherapy in Upper Tract Urothelial Carcinoma

Study 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.

Official Title
-----------------
Carcinomes urothéliaux Des Voies excrétrices supérieures traitées en Vie réelle Par immunothérapie (VESUVIO) : étude rétrospective Nationale

Conditions
-----------------
Urothelial Carcinoma

Intervention / Treatment
-----------------
* Other: Evaluation of anti-PD-(L)1 immunotherapy efficacy


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with advanced/metastatic UTUC treated with second-line anti-PD-(L)1 immunotherapy<br> | Other: Evaluation of anti-PD-(L)1 immunotherapy efficacy<br>* Non Applicable, research on data<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival on anti-PD-(L)1 immunotherapy |  | 2 years after immunotherapy initiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best Objective Radiologic Response | Evaluated by RECIST v1.1 The Response Evaluation Criteria in Solid Tumors (RECIST) is a standard system to measure how cancer responds to different treatments.It permits to evaluate the response according to the evolution of the lesions. | Up to 7 years maximum | 
| Overall survival |  | 5 years after immunotherapy initiation | 
| Progression free survival |  | 6 months after immunotherapy initiation | 
| Progression free survival |  | 1 year after immunotherapy initiation | 
| Progression free survival |  | 2 years after immunotherapy initiation | 
| Progression free survival |  | 3 years after immunotherapy initiation | 
| Duration of immunotherapy treatment | Treatment tolerability | Up to 7 years after immunotherapy initiation | 
| Reasons for treatment discontinuation |  | Up to 7 years after immunotherapy initiation | 
| Translational study of predictive biomarkers of efficacy |  | Up to 7 years after immunotherapy initiation |