Renal Cell Cancer
Conditions
Keywords
Metastatic renal cell carcinoma, Avastin, Bevacizumab
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.
Interventions
DRUGBevacizumab
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.
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed advanced and/or metastatic renal cell cancer * No contraindications for Avastin according to summary of product characteristics (SmPC)
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Advanced and/or Metastatic RCC Participants 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. | 359 |
| Total | 359 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Administrative reasons | 65 |
| Overall Study | Cancer progression | 171 |
| Overall Study | Death from cancer | 20 |
| Overall Study | Death from other cause | 8 |
| Overall Study | Enrolled, not treated | 6 |
| Overall Study | Lost to Follow-up | 8 |
| Overall Study | Other | 17 |
| Overall Study | Refusal of treatment / poor cooperation | 38 |
| Overall Study | Serious adverse event | 32 |
Baseline characteristics
| Characteristic | Advanced and/or Metastatic RCC Participants |
|---|---|
| Age, Continuous | 65.5 years STANDARD_DEVIATION 10.1 |
| Sex/Gender, Customized Female | 114 participants |
| Sex/Gender, Customized Male | 242 participants |
| Sex/Gender, Customized Not available | 3 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 325 / 359 |
| serious Total, serious adverse events | 72 / 359 |
Outcome results
Primary
Cumulative Dose of Immunotherapy (Interferon Alpha-2a) in Daily Routine
Time frame: Up to 52 weeks
Population: FAS. Data were not analyzed for this outcome measure as therapy doses and pattern were not recorded numerically.
Primary
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
Population: FAS
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Advanced and/or Metastatic RCC Participants | Overall Survival (OS) Time | 28.7 months |
Primary
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
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Advanced and/or Metastatic RCC Participants | Percentage of Participants With Best Overall Tumor Response | CR | 5.3 percentage of participants |
| Advanced and/or Metastatic RCC Participants | Percentage of Participants With Best Overall Tumor Response | PR | 21.9 percentage of participants |
| Advanced and/or Metastatic RCC Participants | Percentage of Participants With Best Overall Tumor Response | SD | 39.1 percentage of participants |
| Advanced and/or Metastatic RCC Participants | Percentage of Participants With Best Overall Tumor Response | PD | 16.6 percentage of participants |
| Advanced and/or Metastatic RCC Participants | Percentage of Participants With Best Overall Tumor Response | Not Evaluable | 17.2 percentage of participants |
Primary
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
Population: FAS. 'Number of participants analyzed' indicate participants who were evaluable for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Advanced and/or Metastatic RCC Participants | Percentage of Participants With Disease Control | 66.3 percentage of participants |
Primary
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
Population: FAS
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Advanced and/or Metastatic RCC Participants | Progression-free Survival (PFS) Time | 10.2 months |