Bevacizumab in Metastatic Renal Cancer
- Registration Number
- NCT02627144
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 365
- Histologically confirmed advanced and/or metastatic renal cell cancer
- No contraindications for Avastin according to summary of product characteristics (SmPC)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Advanced and/or Metastatic RCC participants Bevacizumab 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. Advanced and/or Metastatic RCC participants Interferon alpha-2a 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.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Best Overall Tumor Response 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 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 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 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 Up to 52 weeks
- Secondary Outcome Measures
Name Time Method