BELOVA Data Collection: Safety and Efficacy of Frontline Bevacizumab Treatment in Participants With Ovarian Cancer 70 Years and Older

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and efficacy in the frontline treatment of ovarian cancer in participants 70 years of age and older in routine clinical practice in Belgium. Bevacizumab will be used in combination with carboplatin/paclitaxel followed by bevacizumab as maintenance in accordance with the Summary of Product Characteristics (SmPC).

Official Title
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BELOVA: A Non-Interventional Study to Collect Data on the Safety and Efficacy of Frontline Bevacizumab Treatment in Ovarian Cancer Patients 70 Years and Older

Conditions
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Ovarian Cancer

Intervention / Treatment
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* Drug: Bevacizumab
* Drug: Carboplatin
* Drug: Paclitaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 70 years and older No treatment with any other investigational agent within 28 days or 2 half-lives (whichever is longer) prior to enrollment Exclusion Criteria: Contraindications, warnings, and precautions for bevacizumab

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Elderly Participants with Ovarian Cancer<br>Elderly participants aged 70 years and older administered frontline treatment for International Federation for Gynecology and Obstetrics (FIGO) stage IV epithelial ovarian, fallopian tube, or primary peritoneal cancer with bevacizumab in combination with chemotherapy according to standard of care. | Drug: Bevacizumab<br>* Bevacizumab will be prescribed by the local clinician according to the SmPC and standard of care for up to 15 months. No treatment will be provided by the Sponsor in this non-interventional study.<br>* Other names: Avastin;Drug: Carboplatin<br>* Carboplatin will be prescribed by the local clinician according to local labeling and standard of care for up to 18 weeks. No treatment will be provided by the Sponsor in this non-interventional study.<br>Drug: Paclitaxel<br>* Paclitaxel will be prescribed by the local clinician according to local labeling and standard of care for up to 18 weeks. No treatment will be provided by the Sponsor in this non-interventional study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants with Adverse Events |  | Per routine clinical practice during bevacizumab treatment (up to 15 months) | 
| Time to First Incidence of Adverse Events of Special Interest |  | Per routine clinical practice during bevacizumab treatment (up to 15 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-Free Survival According to Response Evaluation Criteria in Solid Tumors (RECIST) |  | Per routine clinical practice during bevacizumab treatment (up to 15 months) and at 6 and 12 months after end of bevacizumab (approximately 27 months overall) | 
| Percentage of Participants with Complete or Partial Response According to RECIST |  | Per routine clinical practice during bevacizumab treatment (up to 15 months) and at 6 and 12 months after end of bevacizumab (approximately 27 months overall) | 
| Overall Survival |  | Per routine clinical practice during bevacizumab treatment (up to 15 months) and at 6 and 12 months after end of bevacizumab (approximately 27 months overall) | 
| Comprehensive Geriatric Assessment Subscale Scores |  | Baseline, end of chemotherapy (up to 18 weeks), and after 10 and 15 months of bevacizumab treatment or at disease progression (up to 15 months overall) | 
| Dosage of Bevacizumab in Milligrams per Kilogram (mg/kg) |  | Every 3 weeks according to SmPC for up to 15 months | 
| Total Number of Bevacizumab Doses |  | Every 3 weeks according to SmPC for up to 15 months | 
| Percentage of Participants by Chemotherapy Used in Combination with Bevacizumab |  | Every 3 weeks per routine clinical practice for up to 18 weeks |