AN OBSERVATIONAL STUDY OF AVASTIN® (BEVACIZUMAB) AS FIRST LINE THERAPY IN PATIENTS WITH ADVANCED OVARIAN CANCER (OSCAR 1)

Study type

• Study topic:
  Disease /health condition

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

  Drug utilisation

  Effectiveness study (incl. comparative)
• Data collection methods:
  Combined primary data collection and secondary use of data

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
• Medical condition to be studied:
  Ovarian cancer

Population studied

• Short description of the study population:
  Patients with advanced ovarian cancer who have received no previous treatment for advanced disease and are receiving or have received Avastin in combination with a standard of care first line chemotherapy regimen.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients with ovarian cancer
• Estimated number of subjects:
  300

Study design details

• Main study objective:
  To obtain ‘real world’ data from routine UK clinical practice for Avastin combined with chemotherapy in the first line treatment of advanced (FIGO stages IIIB, IIIC and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer (i.e. advanced ovarian cancer, aOC) and clinically relevant subgroups.
• Outcomes:
  - The incidence of all adverse events - Clinical Efficacy, as measured by progression free survival, after all subjects have been followed for a minimum of 12 months, -Response rate and overall survival-To describe:a) the key demographic characteristics and medical history of the population receiving Avastin for first line treatment of aOC in the UKb)dosage, schedule, timing and reasons for commencing and discontinuing treatment with Avastin.c)the dosage and schedule of chemotherapies used in combination with Avastin-To assess quality of life (QoL)
• Data analysis plan:
  There are no predefined hypotheses regarding the primary and secondary objectives of the study. The primary objectives are to characterise the adverse event profiles observed in routine UK clinical practice as well as estimate PFS. Primary and secondary safety, demographic, treatment and outcome data will be summarised using descriptive statistics and 95% confidence intervals where appropriate.Time to PFS & OS data will be analysed using Kaplan-Meier methods. If data permit and assumptions hold, the effect of baseline stage of disease, time of Avastin dosing compared to time of chemotherapy, surgery and age on PFS & OS will be assessed using the Cox proportional hazards model. Other variables may also be explored.