Observational study of Olaparib in UK patients with ovarian cancer
Research type
Research Study
Full title
Olaparib Real-world Utilization and Clinical Outcomes in France, Italy, and the UK OVAL-1: A pan-European non-interventional, retrospective observational cohort study of patients with BRCA mutated advanced (FIGO stage III-IV) ovarian cancer treated with olaparib tablets in the first-line maintenance setting
IRAS ID
284106
Contact name
Charles Gourley
Contact email
Sponsor organisation
AstraZeneca
Clinicaltrials.gov Identifier
NA, NA
Duration of Study in the UK
5 years, 2 months, 30 days
Research summary
Summary of Research
Olaparib is a medicine that can be used for the treatment of advanced ovarian cancer in patients with a mutation in their BRCA gene. This is a retrospective, observational medical records review study of patients with BRCA-mutated advanced ovarian cancer who received maintenance olaparib as a first line treatment in France, Italy or the UK.
The overall aim of this study is to generate early real-world evidence on patterns of use of olaparib, olaparib-associated clinical outcomes and to understand the clinical and demographic characteristics of patients who are treated with olaparib in routine clinical practice.
The study population in the UK will be approximately 120 patients from NHS sites in England, Scotland and Wales. Patients who received olaparib through the Early Access Program (EAP) or were treated with olaparib outside the EAP, will be eligible for inclusion in the study. Approximately 370 patients will be included in the study across all three countries.
The study is based on retrospective collection of data from patients' medical records. Where the data will be collected by members of the direct care team, patient consent will not be required. Where centres require support from the local clinical research organisation (external researchers) for data collection, then informed consent will be sought from these patients in order to allow the external researcher access to their medical records. All data for deceased patients will be collected by the direct care team to preserve confidentiality.
Data collected will relate to progression free survival, time to olaparib treatment discontinuation, clinical characteristics, details of treatments, chemotherapy outcomes and healthcare resource utilisation (i.e. numbers of hospital attendances and admissions). There will be no changes to patient management for the study and no requirement for additional tests, investigations or visits.
Summary of Results
1. Study identification
Short title: Olaparib Real-world Utilisation and Clinical Outcomes in France, Italy and the UK Full title: OVAL-1: A pan-European non-interventional, retrospective observational cohort study of patients with BRCA-mutated advanced (FIGO stage III-IV) ovarian cancer treated with olaparib tablets in the first-line maintenance setting IRAS Project ID: 284106 Research Ethics Committee reference: 20/ES/0091 ClinicalTrials.gov ID: NCT04532645
2. Who sponsored the study and how can I contact them?
The sponsor of this study was AstraZeneca UK Ltd. This means they were responsible for setting up and running the study. They also provided the money to fund it. AstraZeneca can be contacted via their website https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fwww.astrazeneca.co.uk%252Fcontact-us.%2FNBTI%2FFv7BAQ%2FAQ%2Fcc33b967-4043-4be4-a5b8-a4ac90b763ab%2F1%2FUicJa1BE6D&data=05%7C02%7Capprovals%40hra.nhs.uk%7C7248ba6632504ac532dc08de3995fabe%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C639011513522215798%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=7CmgLb37E5rle0EGB1YIa05BvDNVAQxYR9U0mvSdUJs%3D&reserved=0 AstraZeneca would like to thank everyone who took part.
This submission/document contains trade secrets and confidential commercial information, disclosure of which is prohibited without providing advance notice to AstraZeneca (AZ) and opportunity to object.3. General information about the research
This research study started in May 2020 and finished in July 2025 (when the study report was completed). Fourteen hospitals across the United Kingdom (UK) took part including data from a total of 115 patients.
The study was carried out to gain a better understanding of how a specific anti-cancer treatment, olaparib (the study treatment), is used to treat people that have BReast CAncer (BRCA)-mutated advanced ovarian cancer in routine practice in the UK. This study was also conducted, separately, in France and Italy to produce data that could be contrasted across countries.
We wanted to find out which types of patients of BRCA-mutated advanced ovarian cancer receive the study treatment in routine practice and how well it works.
Specifically, the study wanted to see how long it took from the start of study treatment until the disease started to get worse (referred to as ‘progression-free survival’ or PFS) and to look at treatment patterns such as the dose of study treatment used, how often patients had to take it, any changes to their dose and whether their treatment was interrupted or stopped at all.
People were able to participate in the study if they were 18 years or older when they received their cancer diagnosis, had received at least one dose of study treatment at a participating hospital before 30th June 2020 and had completed their first treatment for ovarian cancer. Patients needed to provide signed informed consent to take part (where this was needed). Patients were not able to take part if they were included in any other clinical studies when they received their first dose of the study treatment.
This study was a ‘retrospective observational research study’. This means that the study only looked at what happened to patients as part of their normal care. For this study, the researchers looked back at patients’ hospital records to collect the data. Only a few specially trained researchers were allowed to look at the hospital records so that the patients’ personal information stayed private. Personal information from the hospital records was removed before the researchers analysed the data for the study.
This study looked at specific characteristics and treatment information from participating patients, extracting this information from their medical records. The study looked at the patient’s medical records from before the time they received their first dose of study treatment, up until 3 years afterwards.4. What medical problems (side effects) did the participants have?
This study only recorded side effects that were listed as reasons for changes in the dose of the study treatment, interruptions in the study treatment or for stopping treatment completely. The most common side effects recorded were anaemia (where the body does not have enough healthy red blood cells or haemoglobin) and fatigue (each recorded in 22 patients [19%]). Next common side effects recorded were: nausea (15 patients [13%]), neutropenia (9 patients [8%]) (where the body has low levels of a certain type of white blood cell), and vomiting (6 patients [5%]).
5. What were the results of the study?
Of the 115 patients who took part in the study, all were female, and the average age was 58 years old at start of their study treatment.
At 3 years after beginning treatment, 57% of patients had not experienced any worsening of the disease, 73% of patients were still alive and 54% of patients had achieved at least a partial (meaning that the cancer had shrunk or reduced but not entirely gone away) or complete response (meaning that all signs of cancer were gone) once during treatment.
In terms of how the study treatment was given, the average first and last doses observed were 600 mg and 500 mg, respectively, across all patients. Sixty-one patients (53%) had at least one treatment dose reduction, and 2 patients (2%) had at least one treatment dose increase during the study. Over half of patients (52%, n=60) had at least one treatment interruption during the study and the most common reason for a treatment interruption was a side effect (44%, n=50).
By the end of the study, 91% (n=105) of patients had stopped taking the study treatment and 10 patients (9%) remained on treatment. The most common reasons for stopping study treatment were completing the prescribed 24 months of treatment (53%, n=56) and worsening of the disease (30%, n=31).
6. How has this study helped patients and researchers?The results will add to existing information about the treatment of patients with advanced ovarian cancer and help clinicians better understand the use of olaparib in the real world and how it compares to other treatment options.
Researchers look at the results of many studies to understand the use of new treatments and how well they work in routine practice. It takes many studies around the world to advance medical science. This summary only shows the results from this one study. Other studies may find different results. In addition, the results may be used to inform the design of new research studies.
7. Are further studies planned?
No further studies are planned by the sponsor at the current time.8. Where can I learn more about this study?
To learn more about this study, you can find more detailed information on this website: https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fwww.hra.nhs.uk%252Fplanning-and-improving-research%252Fapplication-summaries%252Fresearch-summaries%252Fobservational-study-of-olaparib-in-uk-patients-with-ovarian-cancer%252F.%2FNBTI%2FFv7BAQ%2FAQ%2Fcc33b967-4043-4be4-a5b8-a4ac90b763ab%2F2%2FxGEz7j8cAX&data=05%7C02%7Capprovals%40hra.nhs.uk%7C7248ba6632504ac532dc08de3995fabe%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C639011513522247496%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=pp7J9htew679AnTPLMnu55g%2FuH6nlPEAsa7x9CaiFxY%3D&reserved=0
You can also find more details about this study at https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fclinicaltrials.gov%252Fstudy%252FNCT04532645%253Fterm%253DOVAL-1%2526intr%253Dolaparib%2526rank%253D1%2FNBTI%2FFv7BAQ%2FAQ%2Fcc33b967-4043-4be4-a5b8-a4ac90b763ab%2F3%2FEf0cioYGkF&data=05%7C02%7Capprovals%40hra.nhs.uk%7C7248ba6632504ac532dc08de3995fabe%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C639011513522266551%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=mbT%2B6EB4Ahhg2LhkTeItwzeyrt%2BTF%2FjUoQyK7Gm597Y%3D&reserved=0
REC name
East of Scotland Research Ethics Service REC 1
REC reference
20/ES/0091
Date of REC Opinion
14 Oct 2020
REC opinion
Further Information Favourable Opinion