AVASTIN® First Line in Metastatic Renal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 365
- 主要终点
- Percentage of Participants With Best Overall Tumor Response
研究概览
简要总结
This is a non-interventional, multicenter study to evaluate efficacy and safety of intravenous bevacizumab (Avastin) in combination with interferon alpha-2a immunotherapy for first-line treatment in participants with advanced and/or metastatic renal cell cancer (mRCC) in daily routine.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Histologically confirmed advanced and/or metastatic renal cell cancer
- •No contraindications for Avastin according to summary of product characteristics (SmPC)
排除标准
- 未提供
研究组 & 干预措施
Advanced and/or Metastatic RCC participants
Participants with mRCC who are being treated with bevacizumab at the recommended dose of 10 milligram per kilogram (mg/kg) of body weight once every 2 weeks as an intravenous infusion, in combination with interferon alpha-2a at the recommended starting dose of 9 million international units (MIU) 3 times a week until disease progression will be observed. No diagnostic or therapeutic interventions will be given other than used in normal daily routine.
干预措施: Bevacizumab (Drug)
Advanced and/or Metastatic RCC participants
Participants with mRCC who are being treated with bevacizumab at the recommended dose of 10 milligram per kilogram (mg/kg) of body weight once every 2 weeks as an intravenous infusion, in combination with interferon alpha-2a at the recommended starting dose of 9 million international units (MIU) 3 times a week until disease progression will be observed. No diagnostic or therapeutic interventions will be given other than used in normal daily routine.
干预措施: Interferon alpha-2a (Drug)
结局指标
主要结局
Percentage of Participants With Best Overall Tumor Response
时间窗: Baseline until progression or intolerable toxicity, whichever occurred first, assessed up to 6 years
Tumor response was assessed as one of the following: Complete response (CR): disappearance of all target lesions and all pathological lymph nodes below 10 millimeter (mm). Partial response (PR): At least a 30 percent (%) decrease in the sum of diameters of target lesions. Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or persistence of non-target lesions.
Percentage of Participants With Disease Control
时间窗: Baseline until progression or intolerable toxicity, whichever occurred first, assessed up to 6 years
Disease control was defined as having achieved CR, PR, and/or SD during the course of the observation. CR: disappearance of all target lesions and all pathological lymph nodes below 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or persistence of non-target lesions.
Progression-free Survival (PFS) Time
时间窗: Baseline until progression or intolerable toxicity or death, whichever occurred first, assessed up to 6 years
PFS time is defined as time between start of therapy and progression or death. Kaplan-Meier estimate was used for evaluation. PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or persistence of non-target lesions.
Overall Survival (OS) Time
时间窗: Baseline until progression or intolerable toxicity or death, whichever occurred first, assessed up to 6 years
OS time is defined as time between start of therapy and date of death. Kaplan-Meier estimate was used for evaluation.
Cumulative Dose of Immunotherapy (Interferon Alpha-2a) in Daily Routine
时间窗: Up to 52 weeks
次要结局
未报告次要终点