Immunotherapy in Upper Tract Urothelial Carcinoma

Assistance Publique - Hôpitaux de Paris350 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

350

Conditions

Urothelial Carcinoma

Interventions

Evaluation of anti-PD-(L)1 immunotherapy efficacyOTHER

Non Applicable, research on data

Medical Language ↔ Plain English

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

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.

Time frame: Up to 7 years maximum

Overall survival

Time frame: 5 years after immunotherapy initiation

Progression free survival

Time frame: 6 months after immunotherapy initiation

Progression free survival

Time frame: 1 year after immunotherapy initiation

Progression free survival

Time frame: 2 years after immunotherapy initiation

Progression free survival

Time frame: 3 years after immunotherapy initiation

Duration of immunotherapy treatment

Treatment tolerability

Time frame: Up to 7 years after immunotherapy initiation

Reasons for treatment discontinuation

Time frame: Up to 7 years after immunotherapy initiation

Translational study of predictive biomarkers of efficacy

Time frame: Up to 7 years after immunotherapy initiation

Immunotherapy in Upper Tract Urothelial Carcinoma

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts