Ovary Cancer
Conditions
Keywords
Ovary cancer, Ovarian neoplasm, BRCA mutated advanced (FIGO stage III-IV) ovarian cancer
Brief summary
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
Detailed description
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
Interventions
DRUGOlaparib
Olaparib
Sponsors
AstraZeneca
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression | 36 months | Progression-free survival (PFS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | 36 months | Overall survival over 36 months |
Countries
France, Italy, United Kingdom
Outcome results
None listed