OCTOPUS: An Observational, Non-interventional, Non-comparative, Retrospective, Multicentre Study in Patients With Advanced Renal Cell Carcinoma (aRCC) Who Initiated Cabozantinib in 2nd Line Under Real-life Setting in France.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 252
- 试验地点
- 27
- 主要终点
- Duration of treatment (DOT) of cabozantinib
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
结局指标
主要结局
Duration of treatment (DOT) of cabozantinib
时间窗: From baseline up to 18 months
Defined as the time between first and last intake of cabozantinib treatment, regardless of the treatment discontinuation reason.
次要结局
- Progression Free Survival (PFS).(From baseline up to 18 months)
- Reasons for cabozantinib discontinuation(From baseline up to 18 months)
- Incidence of all adverse events (AEs).(From baseline up to 30 days after cabozantinib last intake)
- DOT of subsequent therapy(From baseline up to 18 months)
- Best Overall Response (BOR), until disease progression/recurrence(From baseline up to 18 months)
- Incidence of all Special Situations.(From baseline up to 30 days after cabozantinib last intake)
- Type of subsequent therapy(From baseline up to 18 months)
- Starting dose of subsequent therapy(From baseline up to 18 months)