Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Carcinoma, Renal Cell

Kidney Neoplasms

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Bevacizumab

Interferons

Interferon-alpha

Interferon alpha-2

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Antiviral Agents

Immunologic Factors

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.

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

Interferon alpha-2a

Clinical Trials

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.

Bevacizumab in Metastatic Renal Cancer

AVASTIN® First Line in Metastatic Renal Cancer

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.

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.

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.

OS time is defined as time between start of therapy and date of death. Kaplan-Meier estimate was used for evaluation.

Hoffmann-La Roche

Participants with metastatic renal cell cancer (mRCC) who were 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 were observed. No diagnostic or therapeutic interventions were given other than used in normal daily routine.

Advanced and/or Metastatic RCC Participants

Age, Continuous

Male

Female

Not available

Sex/Gender, Customized

Safety set included all participants who have received at least once one dose of bevacizumab.

Medical Communications

Not Evaluable

Full analysis set (FAS) included all participants who received at least one dose of study medication and have at least one post dose efficacy assessment, following the intention-to-treat principle. 'Number of participants analyzed' indicate participants with non-missing tumor response data.

Percentage of Participants With Best Overall Tumor Response

FAS. 'Number of participants analyzed' indicate participants who were evaluable for this measure.

Percentage of Participants With Disease Control

Progression-free Survival (PFS) Time

Overall Survival (OS) Time

FAS. Data were not analyzed for this outcome measure as therapy doses and pattern were not recorded numerically.

Cumulative Dose of Immunotherapy (Interferon Alpha-2a) in Daily Routine

Overall Study

Spots Global Cancer Trial Database for Bevacizumab in Metastatic Renal Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial