Bevacizumab in Metastatic Renal Cancer

Study Overview
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Brief Summary
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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.

Official Title
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AVASTIN® First Line in Metastatic Renal Cancer

Conditions
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Renal Cell Cancer

Intervention / Treatment
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* Drug: Bevacizumab
* Drug: Interferon alpha-2a


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed advanced and/or metastatic renal cell cancer No contraindications for Avastin according to summary of product characteristics (SmPC) Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Advanced and/or Metastatic RCC participants<br>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. | Drug: Bevacizumab<br>* Bevacizumab will be administered at the recommended dose of 10 mg/kg of body weight once every 2 weeks as an intravenous infusion until disease progression.<br>* Other names: Avastin;Drug: Interferon alpha-2a<br>* Interferon alpha-2a will be administered at the recommended starting dose of 9 MIU 3 times a week until disease progression.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Best Overall Tumor Response | 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. | Baseline until progression or intolerable toxicity, whichever occurred first, assessed up to 6 years | 
| Percentage of Participants With Disease Control | 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. | Baseline until progression or intolerable toxicity, whichever occurred first, assessed up to 6 years | 
| Progression-free Survival (PFS) Time | 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. | Baseline until progression or intolerable toxicity or death, whichever occurred first, assessed up to 6 years | 
| Overall Survival (OS) Time | OS time is defined as time between start of therapy and date of death. Kaplan-Meier estimate was used for evaluation. | Baseline until progression or intolerable toxicity or death, whichever occurred first, assessed up to 6 years | 
| Cumulative Dose of Immunotherapy (Interferon Alpha-2a) in Daily Routine |  | Up to 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metastatic renal cell carcinoma, Avastin, Bevacizumab