This prospective, multi-center, observational study will assess the safety and efficacy of Avastin (bevacizumab) in daily practice in patients with metastatic colorectal cancer who have received no previous treatment for advanced disease and are receiving Avastin in combination with a standard of care first-line chemotherapy regimen. Data will be collected for 1.5 years or until death.
Study Type
OBSERVATIONAL
Enrollment
719
Bevacizumab was administered as part of standard first-line treatment
Capecitabine/oxaliplatin were administered along with bevacizumab as part of standard first-line treatment
Fluorouracil/folinic acid/oxaliplatin were administered along with bevacizumab as part of standard first-line treatment
Percentage of Participants with Serious Adverse Events (SAEs)
An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires new in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator's judgment or requires intervention to prevent one or other of these outcomes.
Time frame: 1.5 years
Percentage of Participants with Grade 3-5 Avastin Related Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, regardless of causal attribution. Adverse events were graded according to NCI-CTCAE, v4.0 (National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0).
Time frame: 1.5 years
Progression-Free Survival
Progression-Free Survival (PFS) was defined as the number of days from start of first-line therapy administration (earliest date of either the start of chemotherapy regimen administration or the start of Avastin) to the date of first occurrence of investigator-assessed disease progression or death. PFS was assessed using Kaplan-Meier method.
Time frame: 1.5 years
Overall Survival
Overall Survival (OS) is defined as the number of days from the start of first-line therapy (earliest date of either the start of chemotherapy regimen administration or the start of Avastin) to death by any cause.
Time frame: 1.5 years
Percentage of Participants with Avastin Related Adverse Events of Special Interest
Adverse events of special interest (AESIs) are defined by their possible association with Avastin® treatment. The adverse events of special interest in this study include all grades of gastrointestinal perforation, fistulae, arterial and venous thromboembolic events, congestive heart failure and pulmonary haemorrhages; and Grade 2-5: hypertension, wound healing complications, proteinuria and mucocutaneous haemorrhages.
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Capecitabine was administered along with bevacizumab as part of standard first-line treatment
Fluorouracil/folinic acid/irinotecan were administered along with bevacizumab as part of standard first-line treatment
Fluorouracil +/- folinic acid were administered along with bevacizumab as part of standard first-line treatment
Royal United Hospital Bath; Diabetes and Lipid Research, Wolfson Centre
Bath, United Kingdom
Wexham Park Hospital; Oncology
Berkshire, United Kingdom
Queen Elizabeth Hospital
Birmingham, United Kingdom
Birmingham Heartlands Hospital; Dept of Oncology
Birmingham, United Kingdom
Bishop Auckland Hospital;Oncology Department
Bishop Auckland, United Kingdom
University Hospital of North Staffordhire
Blackpool, United Kingdom
Bradford Royal Infirmary; Dept of Medical Oncology C/O Ward15
Bradford, United Kingdom
Bristol Haematology and Oncology Centre
Bristol, United Kingdom
West Suffolk Hospital Nhs Trust; Gi Corridor
Bury St Edmunds, United Kingdom
Kent & Canterbury Hospital
Canterbury, United Kingdom
...and 33 more locations
Time frame: 1.5 years
Reasons for Discontinuation of Avastin
Time frame: 1.5 years
Median Progression Free Survival from Four Avastin Studies
PFS was defined as the number of days from start of first-line therapy administration (earliest date of either the start of chemotherapy regimen administration or the start of Avastin) to the date of first occurrence of investigator-assessed disease progression or death. The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only. Median PFS is presented for data from other registration trials and similar observational studies.
Time frame: 1.5 years (ACORN)
Median Overall Survival from Four Avastin Studies
OS is defined as the number of days from the start of first-line therapy (earliest date of either the start of chemotherapy regimen administration or the start of Avastin) to death by any cause. The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only. Median OS is presented for data from other registration trials and similar observational studies.
Time frame: 1.5 years (ACORN)
Percentage of Participants with Comparative AEs from Four Avastin® Studies
Comparative AEs included Gastrointestinal perforation; Haemorrhage (specific grade); All Haemorrhages; Hypertension; and Arterial thromboembolic events (cerebrovascular accident, myocardial infarction, transient ischaemic attack and other). The specific grade of haemorrhage was 3/4 for BRITE, 3/4 for BEAT and 3-5 for ARIES. The specific grade for ACORN was unknown. The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only.
Time frame: 1.5 years (ACORN)
Median Age of Participants in Four Avastin® Studies
The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only.
Time frame: Baseline
Percentage of Participants Over (or equal to) 75 Years of Age in Four Avastin Studies
The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only.
Time frame: Baseline
Percentage of Males and Females in Four Avastin Studies
The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only.
Time frame: Baseline
Eastern Cooperative Oncology Group (ECOG) Performance Status in Four Avastin Studies
ECOG Performance Status measured on-therapy (time between first dose and last dose date) assessed participant's performance status on 5 point scale: 0 is equal to (=) fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory (greater than \[\>\] 50% of waking hours \[hrs\]), capable of all self care, unable to carry out any work activities; 3=capable of only limited self care, confined to bed/chair \>50% of waking hrs; 4=completely disabled, cannot carry on any self care, totally confined to bed/chair; 5=dead. The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only.
Time frame: 1.5 years (ACORN)
Race/Ethnicity of Participants in Four Avastin Studies
The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only.
Time frame: Baseline
Percentage of Participants at Stage IV (at diagnosis) in Four Avastin Studies
The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only.
Time frame: Baseline
Percentage of Participants that Received Previous Systematic Treatment for CRC in Four Avastin Studies
The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only.
Time frame: Baseline
Sites of CRC in Four Avastin Studies
The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only.
Time frame: Baseline
Percentage of Participants with Primary Resection in Four Avastin Studies
The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only.
Time frame: Baseline
Metastatic Sites of CRC in Four Avastin Studies
The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only.
Time frame: Baseline
Ongoing Patient Medical Conditions in Four Avastin Studies
The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only.
Time frame: Baseline
Weeks of Further Treatment After 1st Line Chemotherapy
Number of weeks of further chemotherapy regimen administered after 1st line treatment.
Time frame: From disease progression until end of study.
Quality of Life as Assessed by the Euro-Quality of Life-5 Dimensions (EQ-5D) Weighted Index Score
The EQ-5D is composed of 5 single-item measures where participants responded to questions assessing health status by responding with either "no problems", "slight problems", "moderate problems", "severe problems" or "extreme \[problem\]/unable to perform" in the following categories: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Based on population surveys, an algorithm was used to combine the responses to each of these 5 measures into 1 single EQ-5D weighted index score ranging from -0.59 (extreme problems) to +1 (no problems) where a negative value indicated a worsening of perceived quality of life and a positive value indicated an improvement of perceived quality of life.
Time frame: Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy
Quality of Life as Assessed by the Euro-Quality of Life-5 Dimensions (EQ-5D) Crosswalk Index Score
The EQ-5D is composed of 5 single-item measures where participants responded to questions assessing health status by responding with either "no problems", "slight problems", "moderate problems", "severe problems" or "extreme \[problem\]/unable to perform" in the following categories: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Based on population surveys, an algorithm was used to combine the responses to each of these 5 measures into 1 single EQ-5D index score ranging from -0.59 (extreme problems) to +1 (no problems) where a negative value indicated a worsening of perceived quality of life and a positive value indicated an improvement of perceived quality of life.
Time frame: Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy
Response to the Burden of Illness Question: In the last three months how many times have health care professionals been to your home?
Time frame: Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy
Response to the Burden of Illness Question: In the last three months how many times have you seen health care professionals at your GP Surgery or day centre?
Time frame: Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy
Response to the Burden of Illness Question: In the last three months how many nights in total did you spend in hospital/hospice?
Time frame: Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy
Response to the Burden of Illness Question: In the last three months how many times did you visit the imaging department for these examinations?
Time frame: Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy
Response to the Burden of Illness Question: What was your employment status before diagnosis?
Time frame: Baseline
Response to the Burden of Illness Question: What is your employment status now?
Time frame: Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy
Response to the Burden of Illness Question: Has your cancer resulted in you seeking support services?
Time frame: Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy
Response to the Burden of Illness Question: Has a previously employed family member had to take time off work to care for you?
Time frame: Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy
Response to the Burden of Illness Question: Has your cancer resulted in a family member seeking support?
Time frame: Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy