The study is observational, not interventional. The study will include patients with advanced ovarian cancer who have been treated in Poland based on a previous early access program, and who are currently being treated under the B.50 drug program, funded by the National Health Fund.
Only patients currently being treated in the B.50 program at 10 selected centers listed on this site may be included in the study.
Of course, any patient in Poland eligible for maintenance treatment with niraparib can receive the drug, regardless of participation in this RWE study.The treatment involves administering niraparib as maintenance therapy for 3 years after the completion of chemotherapy, provided that the patient has responded to systemic treatment (NED, CR, PR).
Patients must be female, ≥18 years of age, able to understand the study procedures, and agree to participate in the study by providing written informed consent.
Patients with a histologically confirmed diagnosis of nonmucinous high - grade epithelial ovarian cancer (serous, endometrial) that is stage III or IV according to the FIGO criteria.
All patients with Stage IV disease are eligible. This includes those with inoperable disease, those who undergo PDS (R0 or macroscopic disease), or those for whom NACT is planned.
All FIGO III patients in spite of residual disease and cytoreductive surgery.
Patient has mucinous, germ cell, transitional cell, or undifferentiated tumor.
Patient has low-grade or Grade 1 epithelial ovarian cancer.
Patient has a known condition, therapy, or laboratory abnormality that might confound the study results or interfere with the patient's participation for the full duration of the study treatment in the opinion of the Investigator.
Patient is pregnant or is expecting to conceive children while receiving study drug or for up to 180 days after the last dose of study drug. Patient is breastfeeding or is expecting to breastfeed within 30 days of receiving the final dose of study drug (women should not breastfeed or store breastmilk for use, during niraparib treatment and for 30 days after receiving the final dose of study treatment).
Patients who complete the Chemotherapy Treatment Period without progressive disease (CR, PR, NED) will start Maintenance Treatment with niraparib after Cycle 6 up to 12 weeks after completion of the chemotherapy. Prior to receiving oral maintenance treatment, patients must have a CBC that demonstrates adequate recovery from hematologic toxicity from chemotherapy: * Absolute neutrophil count ≥1,500 cells/μL * Platelet count ≥100,000 cells/μL * Hemoglobin ≥10 g/dl
Other
Retrospective
Niraparib 200/300 MG
DrugWe expect to enroll approximately 300 patients from about 10 sites. Treatment part of study. Part I- looking retrospectively at the time period JAN 2021-MAR 2023. The retrospective data will include patients who are enrolled in niraparib treatment: * under the EAP (started in JAN 2021, in continuation) * under the B.50 drug program, which began in January 2022 Of note, the retrospective multi-center observational study will involve about 30 patients treated with niraparib in EAP (FIGO III R0 after PDS included) and patients who were treated with niraparib before starting RWE (about 120 pts) (JAN 2021- MAR 2023) by the drug program B.50 which has been started to adapt on 1st of Jan, 2022. FIGO III PDS to R0 patients are included to this study. Part II- looking prospectively at the time period APR 2023 to DEC 2025. The prospective data will include patients who are enrolled in niraparib treatment under the B.50 drug program. The prospective multi-center observational study will i
Safety and tolerability.
Safety and tolerability of niraparib treatment in Poland. Strict monitoring of safety profile (e.g. blood test is performed every 7 days during first month of treatment and after each changing of dose, blood pressure is performed every 7 days within the first two months then every month within the first year).
PFS measured from the time of the first dose of niraparib.
The primary PFS analysis will be based upon the Investigator's assessment per Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 criteria, Appendix 2. The day considered as disease progression is the day of the CT examination on which progression was found according to RECIST 1.1 criteria. PFS is defined as the time from first dose of niraparib starting until objective tumor progression or death.
Chemosensitivity based on KELIM.
Chemosensitivity based on KELIM as a surrogate marker for platinum sensitivity to assess for niraparib response as a standard procedure due to the B.50 drug program.I will be measured after the chemotherapy based on CA125 making during the first 100 days of treatment.
OS (Overall Survival).
Overall survival is defined as the time from the start of therapy to the day of patient's death to any cause.
PFS depending on starting niraparib therapy.
Evaluation of outcomes of including patients in therapy up to 4, 8, 12 weeks after completion of platinum-based chemotherapy
DCR (Disease Control Rate).
Disease control rate (DCR) is defined as the percentage of patients who have achieved complete response, partial response, and stable disease to the niraparib intervention.
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