Bevacizumab in Metastatic Renal Cancer

Hoffmann-La Roche365 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

365

Conditions

Renal Cell Cancer

Interventions

BevacizumabDRUG

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.

Interferon alpha-2aDRUG

Interferon alpha-2a will be administered at the recommended starting dose of 9 MIU 3 times a week until disease progression.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Freiburg im Breisgau, Germany

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline until progression or intolerable toxicity or death, whichever occurred first, assessed up to 6 years

Data from ClinicalTrials.gov

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