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AVASTIN® First Line in Metastatic Renal Cancer
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.
Details
| Lead sponsor | Hoffmann-La Roche |
|---|---|
| Status | COMPLETED |
| Enrolment | 365 |
| Start date | 2008-01 |
| Completion | 2014-09 |
Conditions
- Renal Cell Cancer
Interventions
- Bevacizumab
- Interferon alpha-2a
Primary outcomes
- 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
Countries
Germany