Olaparib Real-world Utilization and Clinical Outcomes in France, Italy, and the UK
Olaparib Real-world Utilization and Clinical Outcomes in France, Italy, and the UK
This is a retrospective observational medical records review study of BRCA mutated advanced
 (FIGO stage III-IV) ovarian cancer patients who received first dose maintenance olaparib in
 1L setting in France, Italy and the UK. Physicians who treated ovarian cancer patients with
 olaparib in 1L setting will be requested to recruit patients to have their clinical data
 abstracted from their clinical records in line with local laws.
Primary Objective(s)

 1. To estimate progression-free survival (PFS) in patients with BRCA-mutated advanced
 ovarian cancer treated with olaparib tablets in real-world first line maintenance
 setting.

 2. To describe olaparib treatment patterns (dosage; frequency of: dosage changes, dose
 interruptions, treatment cessation) in patients with BRCA-mutated advanced ovarian
 cancer treated in real-world first line maintenance setting.

 Secondary Objective(s)

 1. To estimate overall survival (OS) in patients with BRCA-mutated advanced ovarian cancer
 treated with olaparib tablets in real-world first line maintenance setting.

 2. To describe reasons for olaparib dosage changes, dose interruptions and treatment
 cessation in patients with BRCA-mutated advanced ovarian cancer treated in real-world
 first line maintenance setting

 3. To describe surgical and chemotherapy outcomes (PR/CR) in patients with BRCA-mutated
 advanced ovarian cancer before initiation of real-world first line maintenance olaparib
 tablets

 4. To describe response rate (RR) to olaparib tablets in patients with BRCA-mutated ovarian
 cancer with partial response to real-world first line chemotherapy.

 5. To describe treatment patterns and clinical outcomes in patients with BRCA-mutated
 advanced ovarian cancer who progressed during olaparib real-world first line maintenance
 therapy (including frequency of treatment interruptions, dosage reductions and treatment
 discontinuations and reasons associated with patterns)

 6. To estimate second progression-free survival (PFS2) in patients with BRCA-mutated
 ovarian cancer who progress while on olaparib real-world first line maintenance therapy.

 7. To describe healthcare resource utilisation in patients with BRCA-mutated advanced
 ovarian cancer treated with olaparib in real-world first line setting.
Inclusion Criteria:

 -  Patients with newly diagnosed, histologically confirmed, advanced (FIGO stage III -
 IV) epithelial ovarian cancer, primary peritoneal cancer and / or fallopian-tube
 cancer who have completed first line platinum-based chemotherapy, in PR/CR and treated
 with at least one dose of olaparib in first line maintenance setting

 -  Patients aged ≥18 years old

 -  Ability and/or willingness to provide a signed informed consent form (where required)

 Exclusion Criteria:

 -  Withdrawal of informed consent (where consent required)

 -  Concurrent participation in any clinical study with an investigational product at the
 time of olaparib initiation