Post-Marketing Observational Prospective Study to Assess Real World Outcomes and the Risk of Myelodysplastic syndromes (MDS)/acute myeloid leukaemia (AML) in Platinum Sensitive Relapsed breast cancer susceptibility gene (BRCA) Mutated Ovarian Cancer Patients Treated with Lynparza (olaparib); the LOCALISE Study

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

  Other
• If ‘other’, further details on the scope of the study:
  Evaluate the risk of developing MDS/AML among BRCAm platinum sensitive relapsed high grade serous epithelial ovarian cancer patients, who responded to the most recent platinum-based chemotherapy, treated with Lynparza in a real world setting.
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  This is an observational (non-interventional), multicentre, international, prospective cohort study of Lynparza maintenance monotherapy (prescribed in line with the EU-approved indication or local product information).

Study drug and medical condition

• Name of medicine:
  LYNPARZA
• Study drug International non-proprietary name (INN) or common name:
  OLAPARIB
• Anatomical Therapeutic Chemical (ATC) code:
  (L01XX46) olaparib

  olaparib
• Medical condition to be studied:
  Acute myeloid leukaemia

  Myelodysplastic syndrome

Population studied

• Short description of the study population:
  Patients aged 18 and older with germline and/or somatic breast cancer susceptibility gene (BRCA) mutated (BRCAm) platinum sensitive relapsed high grade serous epithelial ovarian cancer, who were in response to the most recent platinum-based chemotherapy and who are on or initiating Lynparza maintenance treatment.
• 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:
  Ovarian Cancer Patients
• Estimated number of subjects:
  765

Study design details

• Main study objective:
  The primary objective of this study is to evaluate the risk of developing MDS/AML among BRCAm platinum sensitive relapsed high grade serous epithelial ovarian cancer patients, who are in response to the most recent platinum-based chemotherapy, treated with Lynparza in real world conditions of clinical practice.
• Outcomes:
  The primary outcome measure is the incidence rate of MDS and/or incidence rate of AML
• Data analysis plan:
  The full analysis set (FAS) will consist of all enrolled patients without a history of MDS/AML prior to Lynparza exposure and who received at least one dose of Lynparza treatment. The FAS will be used for all analyses, although patients with a history of MDS/AML are eligible for the study, they will not be included in the FAS. Data from these patients will be listed or summarised as appropriate depending on the number of patients, and will be reported separately. Patient baseline and disease characteristics will be described using summary statistics.