Belova: A non-interventional study to collect data on the safety and efficacy of frontline bevacizumab treatment in Figo Stage IV Ovarian Cancer patients ≥ 70 (BELOVA)

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

  Effectiveness study (incl. comparative)

  Safety study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Post-authorization study, Prescription event monitoring

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  BEVACIZUMAB
• Medical condition to be studied:
  Ovarian cancer

Population studied

• Short description of the study population:
  Elderly patients aged ≥ 70y, for whom it has been decided to administer frontline treatment for FIGO stage IV epithelial ovarian, fallopian tube or primary peritoneal cancer with bevacizumab in combination with chemotherapy according to standard of care and in line with the current summary of product characteristics (SPC)/local labeling. Patients should not have any contraindication to bevacizumab therapy as per the local label and are eligible for observation in this cohort if the following applies: Written informed consent where local regulations allow or require it within up to 4 weeks after commencing treatment. Each patient will undergo comprehensive geriatric assessment (CGA) at the start and a limited CGA during treatment, and the treatment pattern and safety profile of each patient will be followed-up until progressive disease. Patients must meet the following criteria for study entry:; 1. Initially diagnosed with frontline stage IV epithelial ovarian, fallopian tube or primary peritoneal cancer; 2. aged ≥70 years; 3. have signed the written informed consent and received a copy.; 4. No treatment with any other investigational agent within 28 days or 2 investigational agent half-lives (whichever is longer) prior to enrolment in this study. Patients who meet any of the following criteria will be excluded from study entry: Contraindications, warnings and precautions for use as specified in the bevacizumab SmPC.
• Age groups:
  • 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:
  Ovarian cancer patients
• Estimated number of subjects:
  100

Study design details

• Main study objective:
  The purpose of this study is to evaluate the safety and efficacy in the frontline treatment of ovarian cancer in a wider selection of patients ≥70 years old in a routine clinical practice in Belgium. Bevacizumab will be used as described in the summary of product characteristics, in combination with carboplatin/paclitaxel followed by bevacizumab as maintenance.
• Outcomes:
  Safety and tolerability of bevacizumab in the frontline treatment of elderly ovarian cancer patients, To describe:·Demographic characteristics and medical history of the elderly population receiving bevacizumab·Clinical Efficacy/progression free survival: start time of bevacizumab until progression or death·Objective Response Rate·Comprehensive Geriatric Assessments evolution·Dosage, schedule of bevacizumab and combined chemotherapies for the treatment of elderly ovarian cancer patients
• Data analysis plan:
  Statistical analyses will be performed primarily for descriptive and estimation purposes. Unless otherwise specified, all statistical hypotheses will be tested at the 5% significance level against two-sided alternatives, and corresponding 95% confidence intervals will be reported as appropriate. The incidence of related AEs and SAEs will be summarized according to the primary system-organ class (SOC) and within each SOC, by the Medical Dictionary for Regulatory Activities (MedDRA) preferred term.Rates and proportions will be associated with a 95% confidence interval according to ‘Agresti-Coull’ method (95% CI).Kaplan-Meier estimates and Kaplan-Meier Curve will be provided for time-to-event variables (PFS). If possible, the median survival time will be reported with its 95% confidence interval based on the nonparametric Brookmeyer and Crowley method.