Colorectal Cancer
Conditions
Brief summary
This prospective observational study will evaluate the safety and efficacy of Avastin (bevacizumab) in patients with metastatic colorectal cancer. Data will be collected from patients receiving Avastin in combination with chemotherapy according to registered indication in routine clinical practice.
Interventions
None listed
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients, \>/= 18 years of age * Metastatic colorectal cancer * Prescribed to receive Avastin according to registered indication
Exclusion criteria
* Patients not eligible for Avastin treatment according to the Summary of Product Characteristics
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With At Least One Adverse Event (AE) | Up to 65 months | An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Clinical Benefit of Complete Response [CR], Partial Response [PR] or Stable Disease [SD] Per Response Evaluation Criteria in Solid Tumors (RECIST) | Up to 65 months | Per RECIST, CR was defined as the disappearance of all target and non-target lesions and normalization of tumor marker level; PR was defined as at least a 30 percentage (%) decrease in the sum of the longest diameter of target lesions, taking as reference the screening sum longest diameter; SD for target lesions was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started and SD for non-target lesions defined as persistence of 1 or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits. PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and nontarget lesions) or the unequivocal progression of existing non-target lesions. |
| Percentage of Participants Who Were Resectable Postbaseline Among the Participants Who Were Unresectable at Baseline | Up to 65 months | — |
| Percentage of Participants With Disease Progression or Death | Up to 65 months | Per RECIST, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and nontarget lesions) or the unequivocal progression of existing non-target lesions. |
| Progression Free Survival (PFS) | Up to 65 months | PFS was defined as the time from the date of informed consent until the date when the participant had progression of disease or died due to any cause. Participants who left the study for reasons other than progression of the disease were censored at the time of their last tumor assessment. Per RECIST, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and non-target lesions) or the unequivocal progression of existing non-target lesions. |
Countries
Serbia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CRC Cohort Participants with metastatic CRC (resectable/unresectable at baseline) received bevacizumab in combination with chemotherapy according to registered indication in routine clinical practice until progression of disease, unacceptable toxicity, lost to follow up, death, or withdrawal of informed consent. | 191 |
| Total | 191 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 7 |
| Overall Study | Death | 2 |
| Overall Study | Disease progression | 47 |
| Overall Study | Lost to Follow-up | 5 |
| Overall Study | Missing | 25 |
| Overall Study | Other | 1 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | CRC Cohort |
|---|---|
| Age, Continuous | 59.31 years STANDARD_DEVIATION 10.23 |
| Sex: Female, Male Female | 71 Participants |
| Sex: Female, Male Male | 120 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 9 / 191 |
| serious Total, serious adverse events | 23 / 191 |
Outcome results
Primary
Percentage of Participants With At Least One Adverse Event (AE)
An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.
Time frame: Up to 65 months
Population: All participants who received at least 1 dose of study drug and underwent subsequent safety assessment were considered for the safety analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CRC Cohort | Percentage of Participants With At Least One Adverse Event (AE) | 15.2 percentage of participants |
Secondary
Percentage of Participants Who Were Resectable Postbaseline Among the Participants Who Were Unresectable at Baseline
Time frame: Up to 65 months
Population: Included participants whose CRC was identified as unresectable at baseline.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CRC Cohort | Percentage of Participants Who Were Resectable Postbaseline Among the Participants Who Were Unresectable at Baseline | 34.5 percentage of participants |
Secondary
Percentage of Participants With Clinical Benefit of Complete Response [CR], Partial Response [PR] or Stable Disease [SD] Per Response Evaluation Criteria in Solid Tumors (RECIST)
Per RECIST, CR was defined as the disappearance of all target and non-target lesions and normalization of tumor marker level; PR was defined as at least a 30 percentage (%) decrease in the sum of the longest diameter of target lesions, taking as reference the screening sum longest diameter; SD for target lesions was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started and SD for non-target lesions defined as persistence of 1 or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits. PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and nontarget lesions) or the unequivocal progression of existing non-target lesions.
Time frame: Up to 65 months
Population: All participants who received at least 1 dose of study drug were included in this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CRC Cohort | Percentage of Participants With Clinical Benefit of Complete Response [CR], Partial Response [PR] or Stable Disease [SD] Per Response Evaluation Criteria in Solid Tumors (RECIST) | 72 percentage of participants |
| Unresectable CRC at Baseline | Percentage of Participants With Clinical Benefit of Complete Response [CR], Partial Response [PR] or Stable Disease [SD] Per Response Evaluation Criteria in Solid Tumors (RECIST) | 69 percentage of participants |
Secondary
Percentage of Participants With Disease Progression or Death
Per RECIST, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and nontarget lesions) or the unequivocal progression of existing non-target lesions.
Time frame: Up to 65 months
Population: Included participants who received at least 1 dose of study drug and had postbaseline tumor assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CRC Cohort | Percentage of Participants With Disease Progression or Death | 76.5 percentage of participants |
Secondary
Progression Free Survival (PFS)
PFS was defined as the time from the date of informed consent until the date when the participant had progression of disease or died due to any cause. Participants who left the study for reasons other than progression of the disease were censored at the time of their last tumor assessment. Per RECIST, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and non-target lesions) or the unequivocal progression of existing non-target lesions.
Time frame: Up to 65 months
Population: Included participants who received at least 1 dose of study drug and had postbaseline tumor assessment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| CRC Cohort | Progression Free Survival (PFS) | 9 months |