Renal Cell Cancer Metastatic
Conditions
Keywords
Tivozanib
Brief summary
The SOGUG-TIVOREAL study is a retrospective observational study with medications. This study is based on the retrospective collection of data from patients who have been treated with Tivozanib as first-line therapy between 03/01/2019 and 08/31/2024 for metastatic renal cell carcinoma (mRCC).
Interventions
None listed
Sponsors
Spanish Oncology Genito-Urinary Group
Adknoma Health Research
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. \- Patients ≥ 18 years old. 2. \- Who have signed the informed consent form, except for patients who were deceased at the time of inclusion. 3. \- Histological diagnosis of stage IV clear cell renal carcinoma. 4. \- Who started treatment with Tivozanib as first-line therapy between March 1, 2019, and August 31, 2024. 5. \- Who received treatment at the participating center.
Exclusion criteria
1. \- Patients previously treated at another center who were later referred to one of the participating centers. In this case, the patient will be included in the center where the treatment was initiated. 2. \- Explicit objection by the subject or their legal representative to participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) | Day 1 | To evaluate the progression-free survival (PFS) in patients with metastatic clear cell renal cell carcinoma (mRCC) from the favorable risk group according to IMDC, treated with Tivozanib monotherapy as first-line therapy. The probability of progression-free survival will be described using the Kaplan-Meier method, along with the 95% confidence intervals of the point estimates, as well as the median time of survival from the start of treatment with Tivozanib until tumor progression or death from any cause, whichever occurs first. RECIST 1.1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) in favorable risk group | Day 1 | To evaluate the overall survival (OS) of patients with metastatic clear cell renal cell carcinoma (mRCC) from the favorable risk group according to IMDC, treated with Tivozanib monotherapy as first-line therapy. The probability of overall survival will be described using the Kaplan-Meier method, along with the 95% confidence intervals of the point estimates, as well as the median survival time from the start of treatment with Tivozanib until death from any cause. RECIST 1.1 |
| Objective response rate (ORR) in favorable risk group | Day 1 | To evaluate the objective response rate (ORR) in patients with metastatic clear cell renal cell carcinoma (mRCC) from the favorable risk group according to IMDC, treated with Tivozanib monotherapy as first-line therapy. ORR is defined as the percentage of patients with tumor size reduction (PR) and/or disappearance (CR) after treatment. RECIST 1.1 |
| Percentage of patients with PR and CR in favorable risk group | Day 1 | To evaluate the percentage of patients with partial response (PR) and complete response (CR) among those with metastatic clear cell renal cell carcinoma (mRCC) from the favorable risk group according to IMDC, treated with Tivozanib monotherapy as first-line therapy. RECIST 1.1 |
| Progression-free survival (PFS) - Intermediate and poor risk group | Day 1 | To evaluate the progression-free survival (PFS) in patients with metastatic clear cell renal cell carcinoma (mRCC) from the intermediate and poor risk groups according to IMDC, treated with Tivozanib monotherapy as first-line therapy. The probability of progression-free survival will be described using the Kaplan-Meier method, along with the 95% confidence intervals of the point estimates, as well as the median time of survival from the start of treatment with Tivozanib until tumor progression or death from any cause, whichever occurs first. RECIST 1.1 |
| Overall survival (OS) - Intermediate and poor risk group | Day 1 | To evaluate the overall survival (OS) in patients with metastatic clear cell renal cell carcinoma (mRCC) from the intermediate and poor risk groups according to IMDC, treated with Tivozanib monotherapy as first-line therapy. The probability of overall survival will be described using the Kaplan-Meier method, along with the 95% confidence intervals of the point estimates, as well as the median survival time from the start of treatment with Tivozanib until death from any cause. RECIST 1.1 |
| Objective response rate (ORR) in poor and intermediate risk group | Day 1 | To evaluate the objective response rate (ORR) in patients with metastatic clear cell renal cell carcinoma (mRCC) from the intermediate and poor risk groups according to IMDC, treated with Tivozanib monotherapy as first-line therapy. ORR is defined as the percentage of patients with tumor size reduction (PR) and/or disappearance (CR) after treatment. RECIST 1.1 |
| Percentage of patients with PR and CR in intermediate and poor risk group | Day 1 | To evaluate the percentage of patients with partial response (PR) and complete response (CR) among those with metastatic clear cell renal cell carcinoma (mRCC) from the intermediate and poor risk groups according to IMDC, treated with Tivozanib monotherapy as first-line therapy. RECIST 1.1 |
| Toxicity profile of Tivozanib | Day 1 | To evaluate the toxicity profile of Tivozanib in the entire study population during the treatment period with Tivozanib, through the evaluation of tivozanib-related toxicities reported in the patients' medical history |
Countries
Spain
Outcome results
None listed