AN OBSERVATIONAL STUDY OF AVASTIN® (BEVACIZUMAB) IN COMBINATION WITH CHEMOTHERAPY FOR TREATMENT OF FIRST LINE METASTATIC COLORECTAL ADENOCARCINOMA (ACORN)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation

  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Drug interaction study

Study drug and medical condition

• Name of medicine:
  AVASTIN
• Study drug International non-proprietary name (INN) or common name:
  BEVACIZUMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (L01XC07) bevacizumab

  bevacizumab
• Additional medical condition(s):
  METASTATIC COLORECTAL ADENOCARCINOMA

Population studied

• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  700

Study design details

• Main study objective:
  To assess the outcomes and the safety of Avastin® and first line chemotherapy regimens for metastatic colorectal cancer in a real world setting in England/the UK and to assess actual day to day disease and patient management.
• Outcomes:
  To obtain real world data of Avastin® combined with various chemotherapy regimens used for the treatment of first line metastatic colorectal cancer in the United Kingdom (UK) as assessed by:- The incidence of all serious adverse events and Grade 3-5 Avastin® related adverse events- Outcomes, as measured by progression-free survival, and duration of survival. -Via capture of all AEs -To describe regimens used in combination with Avastin® -To describe dosage, schedule, duration and reason for discontinuation of treatment with Avastin®-To describe the characteristics of populations receiving Avastin® -To explore deviations from Avastin® SmPC.-To describe the treatment paths for mCRC after 1st line treatment - To assess quality of life (QoL) d
• Data analysis plan:
  There is no predefined hypothesis regarding the magnitude of the outcome variables of any regimen or the frequency or severity of adverse events.Safety and outcomes will be analysed using standard statistical methods for cohort studies for the overall study population and by concomitant first-linechemotherapy for metastatic colorectal cancer.Clinical outcomes will be evaluated and reviewed after 700 patients have been enrolled.