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177 Efficacy of niraparib by timing of surgery and residual disease: a post-hoc analysis of patients in the PRIMA/ENGOT-OV26/GOG-3012 study
  1. R O’cearbhaill1,
  2. JA Pérez-Fidalgo2,
  3. BJ Monk3,
  4. C Vulsteke4,
  5. C Mccormick5,
  6. S Hietanen6,
  7. RG Moore7,
  8. G Artioli8,
  9. MS Shahin9,
  10. F Selle10,
  11. WH Bradley11,
  12. K Baumann12,
  13. D O’malley13,
  14. I Tusquets14,
  15. BM Slomovitz15,
  16. T Levy16,
  17. F Joly17,
  18. I Malinowska18,
  19. D Gupta18 and
  20. A González-Martin19
  1. 1GOG and the Department of Medicine, Memorial Sloan Kettering Cancer Center, Weill Cornell Medical College, New York, NY, USA
  2. 2Department of Medical Oncology, INCLIVA University Hospital of Valencia, CIBERONC, Valencia, Spain
  3. 3Arizona Oncology (US Oncology Network), University of Arizona College of Medicine, Creighton University School of Medicine, Phoenix, AZ, USA
  4. 4BGOG and the Department of Medical Oncology and Hematology, AZ Maria Middelares, Ghent, Belgium, and the Department of Molecular Imaging, Pathology, Radiotherapy, and Oncology, Center for Oncological Research, Antwerp University, Antwerp, Belgium
  5. 5GOG and Legacy Medical Group Gynecologic Oncology, Portland, OR, USA
  6. 6Department of Obstetrics and Gynecology, Turku University Hospital, Turku, Finland
  7. 7Division of Gynecologic Oncology, Wilmot Cancer Institute, Department of Obstetrics and Gynecology, University of Rochester, Rochester, NY, USA
  8. 8ULSS 3 Serenissima, U.O.C. Oncologia ed Ematologia Oncologica, Mirano, Venice, Italy
  9. 9Abington Hospital-Jefferson Health, Sidney Kimmel Cancer Center of Thomas Jefferson University, Willow Grove, PA, USA
  10. 10GINECO and Groupe Hospitalier Diaconesses-Croix Saint Simon, Paris, France
  11. 11GOG and the Department of Obstetrics and Gynecology, Medical College of Wisconsin, Milwaukee, WI, USA
  12. 12Arbeitsgemeinschaft Gynäkologische Onkologie and the Department of Gynecology and Obstetrics, Klinikum der Stadt Ludwigshafen, Ludwigshafen, Germany
  13. 13Ohio State University, James Comprehensive Cancer Center, Columbus, OH, USA
  14. 14Medical Oncology Department, Hospital del Mar, Barcelona, Spain
  15. 15Broward Health, Florida International University Wertheim College of Medicine, Miami, FL, USA
  16. 16Department of Obstetrics and Gynecology, Wolfson Medical Center, Sackler School of Medicine, Tel Aviv University, Holon, Israel
  17. 17Medical Oncology Department, Centre Francois Baclesse, Caen, France
  18. 18GlaxoSmithKline, Waltham, MA, USA
  19. 19Grupo Español de Investigación en Cáncer de Ovario (GEICO) and Medical Oncology Department, Clínica Universidad de Navarra, Madrid, Spain


Introduction/Background*Niraparib is a poly(ADP-ribose) polymerase (PARP) inhibitor approved as maintenance treatment for patients (pts) with newly diagnosed advanced or recurrent ovarian cancer following a response to platinum-based chemotherapy (CT) doublet. The PRIMA/ENGOT-OV26/GOG-3012 (NCT02655016) study showed that niraparib following first-line treatment improved progression-free survival (PFS) in the overall intention-to-treat (ITT) population (hazard ratio [HR] 0.62; 95% CI 0.50–0.76).

Methodology This double-blind, placebo (PBO)-controlled, phase 3 trial evaluated niraparib in pts with newly diagnosed, advanced, high-grade serous or endometrioid ovarian, primary peritoneal, or fallopian tube cancer with a complete or partial response to first-line CT. Pts were considered to be at a high risk for disease progression based on their clinical characteristics. This post-hoc analysis presents the efficacy of niraparib, measured by PFS, based on time of surgery and residual disease status, and was not powered to determine differences among the subgroups.

Result(s)*Data cutoff was May 2019. In total, 733 pts were randomized in the PRIMA study. Efficacy outcomes by surgical timing, either primary debulking surgery (PDS) or interval debulking surgery (IDS), and postoperative residual disease status, either no visible residual disease (NVRD) or visible residual disease (VRD), are shown in table 1. Pts who underwent PDS or IDS had similar efficacy with niraparib maintenance treatment versus PBO in the ITT population (PFS HRs were 0.67 and 0.57, respectively). Niraparib treatment reduced risk of progression by 42% in pts who received PDS and had VRD, 35% in those with IDS and NVRD, and 59% in those with IDS and VRD. Efficacy was not evaluable for pts with PDS and NVRD due to low sample size.

Abstract 177 Table 1

Efficacy results by time of surgery and visible residual disease status

Conclusion*In this post-hoc analysis, the impact of residual disease after PDS or IDS on the efficacy of niraparib was comparable across subgroups. Pts with IDS and VRD had the highest reduction in the risk of progression.

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