Platinum-sensitive Recurrent Serous Ovarian Cancer
Conditions
Keywords
women, platinum sensitive, recurrent, serous, ovarian cancer, BRCA, PARP, Olaparib
Brief summary
This study will be carried out as a retrospective, non-interventional observational review of medical records for patients in multiple countries with platinum-sensitive recurrent serous ovarian cancer. The objectives are to describe in a real-world population, treatment patterns, BRCA mutation testing and results, overall survival, health care utilization and also to estimate rates of selected treatment- and/or disease-related side effects
Interventions
OTHERData Collection
Colleciton of data from medical records only
Sponsors
RTI Health Solutions
A+A Healthcare Marketing Research
Freelance CRA (FCRA)
AstraZeneca
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. First determined to have platinum-sensitive recurrent serous ovarian cancer between January 1, 2009, and December 31, 2013 (study entry period), as defined by no evidence of disease progression for at least 6 months after completion of a first-line platinum-based chemotherapy regimen; the first date of platinum-sensitive recurrence between January 1, 2009 and December 31, 2013 will define the study index date. 2. At least 18 years of age on the index date. 3. Fully documented medical history related to the patient's ovarian cancer treatment beginning with initial diagnosis of serous ovarian cancer. 4. Patients can be either alive or deceased at the time of medical record abstraction.
Exclusion criteria
1\. Ever taken an investigational product as part of an interventional clinical trial for ovarian cancer.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Best response to therapy and date of response for each subsequent therapy line post-index | Data will be collected retrospectively from medical records | Response categories: complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD) Criteria on which physicians determined therapy response also will be captured (e.g., symptoms, radiological and/or other imaging findings, CA-125 levels, physical exam, or other criteria). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival, by therapy line | Data will be collected retrospectively from medical records | Defined as time from initiation of the therapy line (including the required first-line platinum-based chemotherapy) until the earliest of progression, death, or end of follow-up (for censored observations) Criteria on which physicians determined progression also will be captured (e.g., symptoms, radiological and/or other imaging findings, CA-125 levels, physical exam, or other criteria) |
| Overall survival, calculated from various time points | Data will be collected retrospectively from medical records | From first diagnosis of ovarian cancer until death or end of follow-up, whichever is earliest From initiation of the required first-line platinum-based chemotherapy regimen until death or end of follow-up, whichever is earliest From the index date (first determination of platinum-sensitive recurrence) until death or end of follow-up, whichever is earliest From initiation of each subsequent, post-index therapy line until death or end of follow-up, whichever is earliest |
Countries
Australia, Belgium, Canada, France, Germany, Israel, Italy, Netherlands, Portugal, South Korea, Spain, Switzerland, United Kingdom
Outcome results
None listed