TP027/#586 A multicenter study of niraparib maintenance therapy in BRCA wild-type, newly diagnosed advanced ovarian cancer: polo trial. (4th December 2022) - Kim, Se Ik
Abstract : Objectives: The POLO trial aims to investigate the efficacy of niraparib maintenance therapy in patients with BRCA wild-type, newly diagnosed advanced ovarian cancer who are not at high risk of recurrence. Methods: The POLO is a multi-center, investigator-initiated, single-arm, phase IV trial of patients with FIGO stage III-IV high-grade serous or high-grade endometrioid ovarian cancer. This study includes patients having both germline and somatic wild-type BRCA1/2 genes, no visible residual tumor after primary cytoreductive surgery, and responses to the postoperative platinum-based combination chemotherapy. Meanwhile, patients who received neoadjuvant chemotherapy are excluded. All enrolled patients are treated with niraparib maintenance therapy for three years or until disease progression, unacceptable toxicity, or withdrawal of patient consent. Results: The primary endpoint of this trial is the 12-month progression-free survival (PFS) rate. The secondary endpoints are overall survival, PFS, time to first subsequent treatment, time to second progression (PFS2), time to the second subsequent treatment, and safety. All patients should provide tumor slides obtained during cytoreductive surgery, for a prospective examination of somatic homologous recombination deficiency (HRD) and homologous recombination repair gene alterations. Pre- and post-niraparib (at the time of disease progression if available) blood samples will be collected for circulating cell-free DNA analyses. Molecular biomarkers that may indicate clinical response/resistance to niraparib will be identified. Conclusions: In total, 102 patients will be recruited from five sites. An interim analysis is planned after recruitment of 68 participants. Accrual is expected to be completed in 2024, followed by presentation of results in 2025.