Urothelial Carcinoma
Conditions
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.
Interventions
OTHEREvaluation of anti-PD-(L)1 immunotherapy efficacy
Non Applicable, research on data
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival on anti-PD-(L)1 immunotherapy | 2 years after immunotherapy initiation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 5 years after immunotherapy initiation | — |
| Progression free survival | 6 months after immunotherapy initiation | — |
| Best Objective Radiologic Response | Up to 7 years maximum | 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. |
| 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 | — |
| Duration of immunotherapy treatment | Up to 7 years after immunotherapy initiation | Treatment tolerability |
Contacts
Primary ContactClément Dumont, Dr
Backup ContactJérôme Lambert, Pr
Outcome results
None listed