Advanced Renal Cell Carcinoma
Conditions
Brief summary
Cabozantinib is an orally bioavailable tyrosine kinase inhibitor (TKI) approved in patients with aRCC previously treated with a Vascular Endothelial Growth Factor (VEGF)-targeted therapy. Cabozantinib has been increasingly used in routine care in second line and more in advanced or metastatic RCC in France. Cabozantinib effectiveness and safety notably in a real-word setting are now well known, but too many questions that arise during the routine care of patients with aRCC remain unanswered by the current literature. Obtaining data on cabozantinib effectiveness and treatment pattern in those participants subpopulations will allow physicians to improve patients care. The aims of this study are to describe the effectiveness - in terms of Duration of Treatment (DOT), Best Overall Response (BOR) and Progression-Free Survival (PFS) - and the safety of second line cabozantinib a real-life setting in France and to address the unanswered questions that arise during the routine care of patients with aRCC treated with cabozantinib in order to improve the care of these participants.
Detailed description
Since 2018, cabozantinib has been increasingly used in routine care in second line and more in advanced or metastatic RCC in France. Cabozantinib effectiveness and safety notably in a real-word setting are now well known, but too many questions that arise during the routine care of patients with aRCC remain unanswered by the current literature. As an example, there is currently no real-world data on cabozantinib in elderly patients (≥ 75 years old); in patients with a systemic therapy after progression under cabozantinib (only one published monocentric retrospective study on 56 participants); or in long responder patients (with a disease controlled after \> 12 months of cabozantinib). Obtaining data on cabozantinib effectiveness and treatment pattern in those patient subpopulations will allow physicians to improve patients care.
Interventions
None listed
Sponsors
Ipsen
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female ≥ 18 age at the time of cabozantinib initiation. * Pathologically confirmed diagnosis of Renal Cell Carcinoma (RCC) considered as advanced at the time of cabozantinib initiation. * Cabozantinib initiated from 1st March 2018 to 1st March 2021 for an advanced RCC. * Cabozantinib initiated in 2nd line according to local Summary of Product Characteristics (SmPC).
Exclusion criteria
* Participant medical file without documented follow-up visits (post-cabozantinib initiation). * Participant alive at study initiation who is opposed to data collection. * Participant who died before study initiation and who was opposed to data collection for research purposes when alive.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of treatment (DOT) of cabozantinib | From baseline up to 18 months | Defined as the time between first and last intake of cabozantinib treatment, regardless of the treatment discontinuation reason. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS). | From baseline up to 18 months | Defined as the time from the date of first cabozantinib intake to the date of first documented progression reported by the investigator or death from any cause. Disease progression will be assessed by tumour response evaluation according to investigator assessment. |
| Incidence of all adverse events (AEs). | From baseline up to 30 days after cabozantinib last intake | Whether they are serious/non-serious, related/unrelated experienced by the participants during cabozantinib treatment period(s). |
| Incidence of all Special Situations. | From baseline up to 30 days after cabozantinib last intake | Whether they are serious/non-serious, related/unrelated experienced by the participants |
| Best Overall Response (BOR), until disease progression/recurrence | From baseline up to 18 months | Defined as the proportion of participants achieving the best response among Complete Response (CR), Partial Response (PR), Stable Disease (SDi) or Disease Progression (DP), The method used for the assessment of response to treatment will be left at the discretion of the physician |
| DOT of subsequent therapy | From baseline up to 18 months | — |
| Starting dose of subsequent therapy | From baseline up to 18 months | — |
| Reasons for cabozantinib discontinuation | From baseline up to 18 months | — |
| Type of subsequent therapy | From baseline up to 18 months | Will be described in terms of type, other TKI, Immuno-Oncology therapy (IO), mammalian Target Of Rapamycin (mTOR) inhibitors, other |
Countries
France
Outcome results
None listed