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515 First de-escalation chemotherapy study in ovarian cancer (OC): non-inferiority study of niraparib maintenance after 3 vs. 6 cycles of platinum-based chemotherapy in completely debulked advanced ‘HRD-positive’ high-grade first-line OC patients
  1. Jalid Sehouli1,2,
  2. Jessica Nguyen2,
  3. Dario Zocholl3,
  4. Klaus Pietzner1,2,
  5. Purificación Estévez-García4,5,
  6. Arantzazu Barquín6,5,
  7. Dionyssios Katsaros7,8,
  8. Elena Biagioli8,
  9. Toon Van Gorp9,10,
  10. Jean-Francois Baurain11,10,
  11. Jaroslav Klát12,13,
  12. Michal Zikán14,13,
  13. Regina Berger15,
  14. Katharina Leitner15 and
  15. Elena Ioana Braicu1,2
  1. 1Charite-Universitätsmedizin Berlin, Department of Gynecology with Center for Oncological Surgery, Campus Virchow Klinikum, Berlin, Germany
  2. 2North-Eastern-German Society of Gynaecologic Oncology, Berlin, Germany
  3. 3Charité Universitätsmedizin Berlin, Institute of Biometry and Clinical Epidemiology, Berlin, Germany
  4. 4Hospital Universitario Virgen del Rocío, Seville, Spain
  5. 5Spanish Ovarian Cancer Research Group, Madrid, Spain
  6. 6Hospital Universitario HM Sanchinarro, Madrid, Spain
  7. 7SCDU Ginecologia e Ostetricia 1U, Ospedale Sant’Anna, AOU Città della Salute e della Scienza di Torino, Torino, Italy
  8. 8Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy
  9. 9University Hospital Leuven Leuven Cancer Institute, Leuven, Belgium
  10. 10Belgium and Luxembourg Gynaecological Oncology Group, Leuven, Belgium
  11. 11Cliniques universitaires Saint-Luc, Bruxelles, Belgium
  12. 12University Hospital and University of Ostrava, Faculty of Medicine, Department of Obstetrics and Gynecology, Ostrava, Czech Republic
  13. 13Central and Eastern European Gynecologic Oncology Group, Prague, Czech Republic
  14. 14Charles University – First Faculty of Medicine and University Hospital Bulovka, Department of Gynecology and Obstetrics, Prague, Czech Republic
  15. 15Medical University of Innsbruck, Department for Gynecology and Obstetrics, Innsbruck, Austria


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.

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