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Abstract
Introduction/Background The backbone of high-grade ovarian cancer management is surgery, chemotherapy and maintenance therapy for advanced stages. Patients with complete resection and HR deficiency (HRD) have the best clinical outcome. This is the first study to evaluate the possibility to reduce the number of chemotherapy cycles in the context of HR deficiency and PARPi maintenance, hence to minimize acute and long term toxicity without compromising efficacy.
The N-PLUS trial is the first trial of chemotherapy de-escalation in OC. We hypothesize that recurrence-free survival (RFS) in patients receiving 3 cycles of chemotherapy followed by maintenance therapy with niraparib is not inferior, defined as a hazard ratio of 1.3 or smaller, to 6 cycles of chemotherapy followed by niraparib in advanced HRD high-grade OC patients with no visible disease following primary tumor debulking.
Methodology In this multicenter, randomized, open-label study 640 patients with advanced HRD high-grade OC with no residual tumor mass following primary tumor debulking will be enrolled, resulting in 80% power and one-sided type I error rate of 5%.
Patients will be randomized 1:1 to receive either 3 cycles carboplatin + paclitaxel and maintenance therapy with niraparib (Arm A) or 6 cycles carboplatin + paclitaxel and maintenance therapy with niraparib (Arm B) for a maximum of 36 months.
Randomization will be performed according to the results of the NGS analysis and stratified either to BRCAm or BRCAwt/NOGGO GIS Score+, FIGO stage III vs. IV, and participating countries.
The primary endpoint will be RFS, secondary endpoints will be OS, TFST, TWIST, PFS2, Quality of Life and safety assessments.
Results NA.
Conclusion NA.
Disclosures Funding/Product/both for this study was provided by GSK. GSK was provided the opportunity to provide a courtesy review of the preliminary version of this publication for accuracy only, but the authors are solely responsible for final content and interpretation.
