A Study to Collect Pre-existing Data on the Administration of Cabozantinib in Participants With Advanced Renal Cell Carcinoma (aRCC) Who Initiated Cabozantinib in 2nd Line in a Real-life Clinical Setting in France. (OCTOPUS)

Ipsen

Status: Completed

Conditions: Advanced Renal Cell Carcinoma

Study type: Observational

Funder types: Industry

Identifiers

NCT05444933

CLIN-60000-454

Details and patient eligibility

About

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.

Full 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.

Enrollment: 252 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

252 participants in 7 patient groups

Sequencing post-cabozantinib

Description:

Participants treated by cabozantinib and who received another systemic therapy post-cabozantinib.

Long responders

Description:

Participants treated by cabozantinib and who had a disease controlled (CR, PR or SDi during \> 12 months after cabozantinib initiation with or without additional local treatment).

Non-responders

Description:

Participants treated by cabozantinib and who had a progressive disease less than 3 months after cabozantinib treatment initiation.

Cabozantinib & rechallenge

Description:

Participants treated by cabozantinib who received systemic therapy and/or had prolonged treatment-free interval (≥ 12 weeks) between two cabozantinib treatment periods. Participants with at least one cabozantinib rechallenge could be included in this subgroup.

Cabozantinib & therapeutic schedules

Description:

Participants treated by cabozantinib and who needed 1/ a dose increase following disease progression and/or a prior reduction, Or 2/ had any dose reduction/dose interruption of cabozantinib (schedule adaptation).

Cabozantinib & local treatment

Description:

Participants treated by cabozantinib and who needed concomitant local treatment (LT) by surgery or radiotherapy

Cabozantinib & elderly patients

Description:

Participants treated by cabozantinib and aged ≥ 75 years