Treatment Patterns and Outcomes Among Advanced Renal Cell Carcinoma (aRCC) Patients Treated With Cabozantinib or Axitinib Therapy: Non Interventional, Retrospective Study Using Data From Public Health England's Cancer Analysis System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 1,540
- 试验地点
- 1
- 主要终点
- Duration of therapy for the index treatments of interest stratified by line of therapy (LoT)
研究概览
简要总结
The present study will aim to describe and understand, in the real-world, the clinical characteristics, treatment patterns and outcomes of advanced renal cell carcinoma (aRCC) patients treated with cabozantinib or axitinib monotherapy in England using the existing data source, Cancer Analysis System (CAS).
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
- •Patients with initial renal cancer diagnosis
- •Patients diagnosed at Stage III or Stage IV (as defined in CAS): as evidence for advanced/metastatic RCC
- •For patients with Stage I/II or patients with missing information on Staging
- •Patients who received SACT1 treatment following initial renal cancer diagnosis through end of enrolment (31 July 2019)
- •Patients who received cabozantinib or axitinib treatment
排除标准
- •Diagnosis of concomitant tumour apart from non-melanoma skin cancer in the three years prior to the diagnosis of aRCC
- •Less than 18 years of age at the time of initial aRCC diagnosis
- •SACT treatment more than 30 days prior to initial aRCC diagnosis
研究组 & 干预措施
Subgroup 1
Patients with index treatment: cabozantinib treatment post vascular endothelial growth factor (VEGF)-targeted therapy in any line, except axitinib.
干预措施: Cabozantinib (Drug)
Subgroup 2
Patients with index treatment: axitinib treatment post VEGF-targeted therapy in any line, except cabozantinib.
干预措施: Axitinib (Drug)
Subgroup 3
Patients with index treatment: cabozantinib treatment post axitinib by line of therapy (2L, 3L, 3L+)
干预措施: Cabozantinib (Drug)
Subgroup 4
Patients with index treatment: axitinib treatment post cabozantinib by line of therapy (2L, 3L, 3L+)
干预措施: Axitinib (Drug)
结局指标
主要结局
Duration of therapy for the index treatments of interest stratified by line of therapy (LoT)
时间窗: From start of index treatment up to the end of treatment or start of subsequent therapy during data collection period (01 January 2011 and 31 January 2020)
Duration of therapy will be measured from the initiation of the index treatment until the projected end date of the index treatment (or start of the subsequent therapy). (subgroups 1 to 4)
Time between subsequent treatment lines
时间窗: From baseline until the end of data collection period (01 January 2011 and 31 January 2020)
Time gap between the projected end date of the index treatment (cabozantinib or axitinib) until the start of the subsequent treatment. (subgroups 1 to 4)
Sequencing of treatments (any treatments received from aRCC diagnosis until the end of follow up or death)
时间窗: From baseline until the end of data collection period (01 January 2011 and 31 January 2020)
Treatment sequencing will be presented using a Sankey diagram that visualises the regimens received within each line of therapy and the number and percentage of patients who received those particular regimens.
次要结局
- Time from aRCC diagnosis to initial SACT initiation(From baseline until the end of data collection period (01 January 2011 and 31 January 2020))
- Time from RCC diagnosis to initial SACT initiation(From baseline until the end of data collection period (01 January 2011 and 31 January 2020))
- Time from RCC diagnosis to treatment initiation of cabozantinib(From baseline until the end of data collection period (01 January 2011 and 31 January 2020))
- Time from RCC diagnosis to treatment initiation of axitinib(From baseline until the end of data collection period (01 January 2011 and 31 January 2020))
- Time from aRCC diagnosis to treatment initiation of cabozantinib(From baseline until the end of data collection period (01 January 2011 and 31 January 2020))
- Overall survival (OS)(From start of index treatment until death or end of data collection period (01 January 2011 and 31 January 2020 whichever occurs first)
- Time from aRCC diagnosis to treatment initiation of axitinib(From baseline until the end of data collection period (01 January 2011 and 31 January 2020))
- Landmark survival(24 months)
- Time to next treatment (or death) (TTNT)(From start of index treatment until the start of subsequent therapy during data collection period (01 January 2011 and 31 January 2020))
- Time to treatment discontinuation (TTTD)(From start of index treatment until discontinuation or death during data collection period (01 January 2011 and 31 January 2020))