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.
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.
Study Type
OBSERVATIONAL
Enrollment
252
CHU Amiens
Amiens, France
CHU Angers
Angers, France
Institut Sainte Catherine
Avignon, France
CHU Besançon
Besançon, France
CHU Bordeaux
Bordeaux, France
CHRU Brest
Brest, France
Centre Chirurgie Urinaire et d'Andrologie
Cabestany, France
CHU Clermont-Ferrand
Clermont-Ferrand, France
APHP (Créteil)
Créteil, France
Centre Hospitalier Annecy-Genevois
Épagny, France
...and 18 more locations
Duration of treatment (DOT) of cabozantinib
Defined as the time between first and last intake of cabozantinib treatment, regardless of the treatment discontinuation reason.
Time frame: From baseline up to 18 months
Best Overall Response (BOR), until disease progression/recurrence
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
Time frame: From baseline up to 18 months
Progression Free Survival (PFS).
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.
Time frame: From baseline up to 18 months
Incidence of all adverse events (AEs).
Whether they are serious/non-serious, related/unrelated experienced by the participants during cabozantinib treatment period(s).
Time frame: From baseline up to 30 days after cabozantinib last intake
Incidence of all Special Situations.
Whether they are serious/non-serious, related/unrelated experienced by the participants
Time frame: From baseline up to 30 days after cabozantinib last intake
Type of subsequent therapy
Will be described in terms of type, other TKI, Immuno-Oncology therapy (IO), mammalian Target Of Rapamycin (mTOR) inhibitors, other
Time frame: From baseline up to 18 months
DOT of subsequent therapy
Time frame: From baseline up to 18 months
Starting dose of subsequent therapy
Time frame: From baseline up to 18 months
Reasons for cabozantinib discontinuation
Time frame: From baseline up to 18 months
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