Urothelial Carcinoma
Conditions
Keywords
immunotherapy, real world experience, efficacy of pembrolizumab, artificial intelligence technology, Artificial Neural Network
Brief summary
The ARON-2 study retrospectively analyze patients treated with pembrolizumab as first-line therapy in patients platinum-unfit or as second-line therapy in patients progressed after previous platinum-based chemotherapy. The amendment has been designed to also analyze patients treated with enfortumab vedotin progressed to previous platinum-based chemotherapy and anti-PD-1/PD-L1 inhibitor.
Interventions
None listed
Sponsors
Study design
Eligibility
Inclusion criteria
* Patients aged \>18y * Histologically confirmed diagnosis of UC of upper and/or lower urinary tract * Histologically or radiologically confirmed metastatic disease * Patients treated with at least one of the following: * Treatment with pembrolizumab in patients progressed after previous platinum-based chemotherapy or as first-line therapy in patients platinum-unfit, and at least 1 cycle of pembrolizumab within the period from 1 January 2018 to 30 November 2021 * Treatment with enfortumab vedotin in patients progressed to previous platinum-based chemotherapy and anti-PD-1/PD-L1 inhibitor and at least 1 cycle of enfortumab vedotin within the period from June 1st 2022 to July 31st 2023
Exclusion criteria
* Patients without histologically confirmed diagnosis of UC * Patients without histologically or radiologically confirmed metastatic disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival (OS) of patients with metastatic Urothelial Cancer (UC) treated with pembrolizumab or enfortumab vedotin | November 15th, 2023 |
| Progression-Free Survival (PFS) of patients with metastatic Urothelial Cancer (UC) treated with pembrolizumab or enfortumab vedotin | November 15th, 2023 |
| Overall Response Rate (ORR) of patients with metastatic Urothelial Cancer (UC) treated with pembrolizumab or enfortumab vedotin | November 15th, 2023 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| prognostic role of smoking attitude, obesity and concomitant medications in patients treated with pembrolizumab or enfortumab vedotin | November 15th, 2023 | Statistical analysis of data obtained by medical charts related to smoking attitude, obesity and concomitant medications in patients with metastatic UC treated with pembrolizumab or enfortumab vedotin |
Countries
Italy