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Niraparib Versus Bevacizumab as Maintenance Therapy in Patients With de Novo Ovarian Cancer Without Homologous Recombination Deficiency

RECRUITINGSponsored by Centre Hospitalier Universitaire de Nīmes
Actively Recruiting
SponsorCentre Hospitalier Universitaire de Nīmes
Started2020-10-01
Est. completion2025-05-31
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted

Summary

Background: High-grade serous epithelial ovarian cancer is a disease with a poor prognosis in the advanced stages (stages III and IV). For patients with no biomolecular abnormalities, there are two maintenance treatments available after first-line chemotherapy: bevacizumab or niraparib. There is no prospective or strong retrospective study comparing these two therapies. Hypothesis: Patients receiving bevacizumab are different from those receiving niraparib. Objective: To compare the progression-free survival (PFS) of patients with high-grade stage III and IV ovarian carcinoma who received chemotherapy with those who received maintenance treatment with bevacizumab and those who received niraparib. Method: Retrospective, multicenter study based on data collected from the patient's medical record. Eligible patients are all patients diagnosed with de novo high-grade serous epithelial ovarian carcinoma who have received first-line platinum-based chemotherapy followed by maintenance treatment with bevacizumab or niraparib. All eligible patients will be included. Patients with a BRCA mutation and/or a positive HRD score will be excluded. Data will be collected using an electronic CRF. The inclusion period is from October 2020 to December 2023.

Eligibility

Age: 18 Years+Sex: FEMALEHealthy volunteers accepted
Inclusion Criteria:

* De novo diagnosis of stage III or IV high-grade epithelial ovarian carcinoma, not candidate for primary tumor reduction surgery.
* De novo diagnosis of high-grade epithelial ovarian carcinoma benefiting from a combination of chemotherapy and maximal cytoreduction surgery
* All patients who have received maintenance treatment after chemotherapy with bevacizumab or niraparib monotherapy.

Exclusion Criteria:

* Disease progression after chemotherapy
* Presence of a BRCA mutation (somatic or germline)
* Positive HRD score

Conditions2

CancerOvarian Carcinoma

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