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17 Safety and patient-reported outcomes in patients receiving niraparib in the PRIMA/ENGOT-OV26/GOG-3012 trial
  1. G Freyer1,
  2. B Pothuri2,
  3. S Han3,
  4. D Chase4,
  5. B Monk4,
  6. F Heitz5,
  7. R Burger6,
  8. L Gaba7,
  9. L Van Le8,
  10. E Guerra9,
  11. D Bender10,
  12. J Korach11,
  13. N Cloven12,
  14. C Churruca13,
  15. P Follana14,
  16. P DiSilvestro15,
  17. JF Baurain16,
  18. K Jardon17,
  19. C Pisano18,
  20. U Peen19,
  21. J Maenpaa20,
  22. P Hoskins21,
  23. E Bacque22,
  24. Y Li22,
  25. L Eliason22 and
  26. A González-Martín23
  1. 1Groupe d’Investigateurs Nationaux pour l’Etude des Cancers Ovariens and Service d’Oncologie Médicale, Centre Hospitalier Lyon-Sud, France
  2. 2Gynecologic Oncology Group (GOG) and the Department of Obstetrics/Gynecology, Perlmutter Cancer Center, NYU Langone Health, USA
  3. 3Department of Obstetrics and Gynecology, University Hospitals Leuven, Belgium
  4. 4Arizona Oncology (US Oncology Network), University of Arizona College of Medicine, USA
  5. 5Department for Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte, Germany
  6. 6University of Pennsylvania, USA
  7. 7Medical Oncology Department, Hospital Clinic de Barcelona, Spain
  8. 8Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, University of North Carolina at Chapel Hill, USA
  9. 9Medical Oncology Department, Breast and Gynecological Cancer Unit, Hospital Ramon y Cajal, USA
  10. 10Department of Obstetrics and Gynecology, University of Iowa, USA
  11. 11Department of Gynecologic Oncology, Chaim Sheba Medical Center, Israel
  12. 12Texas Oncology, USA
  13. 13Hospital Universitario Donostia, Spain
  14. 14GINECO and Centre Antoine Lacassagne, France
  15. 15Department of Obstetrics and Gynecology, Women and Infants Hospital/Alpert School of Medicine at Brown University, USA
  16. 16Université Catholique de Louvain and Cliniques Universitaires Saint-Luc, Belgium
  17. 17Department of Obstetrics and Gynecology, McGill University, Canada
  18. 18Department of Urology and Gynecology, Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, Italy
  19. 19Herlev University Hospital, Denmark
  20. 20Tampere University Central Hospital, Finland
  21. 21British Columbia Cancer Agency, Vancouver Centre, Medical Oncology, Canada
  22. 22GlaxoSmithKline, USA
  23. 23Grupo Español de Investigación en Cáncer de Ovario (GEICO) and Medical Oncology Department, Clínica Universidad de Navarra, Spain


Introduction Niraparib is a poly(ADP-ribose) polymerase inhibitor approved for treatment in heavily pretreated patients and maintenance of patients with newly diagnosed or recurrent ovarian cancer following a response to platinum-based chemotherapy. Here we report safety and patient-reported outcomes (PROs) in the overall population and subgroups from PRIMA/ENGOT-OV26/GOG-3012 (NCT02655016).

Methods This double-blind, placebo-controlled, phase 3 study randomized 733 patients. Patients received a 300-mg QD fixed starting dose (FSD) of niraparib or placebo for 36 months or until progression/toxicity. A protocol amendment introduced an individualized starting dose (ISD): 200 mg in patients with body weight <77 kg or platelets <150,000/µL, or 300 mg in all others. The primary endpoint was PFS; safety and PROs were secondary endpoints. Safety data were collected at each visit and graded using CTCAE v4.03. PRO instruments (FOSI, EQ-5D-5L, EORTC-QLQ-C30, and EORTC-QLQ-OV28) were collected Q8W for 56 weeks, then Q12W while a patient received treatment.

Results In the overall population, the most common grade ≥3 treatment-emergent adverse events (TEAEs) were hematologic (table 1). In patients receiving ISD, these TEAEs decreased. No treatment-related deaths occurred. PRO analysis showed no difference in niraparib-treated patients versus placebo in the overall population or in the homologous recombination deficient, homologous recombination proficient, FSD, and ISD subgroups.

Abstract 17 Table 1

Conclusions ISD incorporation improved the safety profile of niraparib without compromising efficacy. Niraparib was well tolerated, with similar PRO scores across the treatment period. Hematologic toxicities were manageable through implementation of dose interruptions and reductions.

Funding GlaxoSmithKline

NCT: NCT02655016

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