{
  "abstract": "Background and Importance Niraparib is a selective inhibitor of PARP-1 and PARP-2 that represents a therapeutic alternative as monotherapy for the maintenance treatment of adult patients with advanced high-grade epithelial ovarian cancer (OC) who have achieved a complete or partial response following first-line platinum-based chemotherapy.Aim and Objectives To evaluate the real-world effectiveness and safety of niraparib as maintenance monotherapy in adult patients with high-grade epithelial OC treated at a tertiary hospital.Material and Methods A retrospective observational study was conducted including all patients diagnosed with epithelial OC who received niraparib between January 2021 and December 2024 at a tertiary hospital. Progression-free survival (PFS) was the primary endpoint to assess effectiveness. Secondary endpoints included overall survival (OS, Kaplan–Meier method), previous treatment lines, starting dose, and toxicity leading to dose reduction or discontinuation. Data were collected from electronic medical records and prescription software. Statistical analysis was performed using SPSS v.29.Results Fifty-five women with stage III/IV OC were included, with a median age at treatment initiation of 64 years (27–86). In 80% of patients, niraparib was administered as first-line maintenance therapy after platinum-based chemotherapy. The initial dose was 200 mg once daily in most patients 89% (49), except for those weighing more than 77 kg, who received 300 mg daily 11% (6). After a median follow-up of 22.85 months, median PFS was 8.34 months (95% CI 4.97–11.22) and OS was 31.86 months (95% CI 27.08–36.65). Regarding safety, dose reduction was required in 69% (38) of patients, and treatment discontinuation due to toxicity occurred in 10.9% (6), mainly haematologic.Conclusion and Relevance The observed effectiveness was lower than that reported in PRIMA/ENGOT-OV26/GOG-3012 (PFS: 8.34 vs 13.8 months). However, adverse events leading to dose reduction (69% vs 71.7%) or discontinuation (10.9% vs 16.3%) were consistent with clinical trial data. Considering the limited sample size, inter-trial differences, and relatively short follow-up, further larger real-world studies are warranted to assess the impact of niraparib in clinical practice.Conflict of Interest No conflict of interest",
  "authors": [
    {
      "affiliations": [
        "Hospital Universitario Reina Sofía De Córdoba, Farmacia Hospitalaria, Córdoba, Spain"
      ],
      "name": "AI Terán Ceballos"
    },
    {
      "affiliations": [
        "Hospital Universitario Reina Sofía De Córdoba, Farmacia Hospitalaria, Córdoba, Spain"
      ],
      "name": "A Gámiz Rejano"
    },
    {
      "affiliations": [
        "Hospital Universitario Reina Sofía De Córdoba, Oncología Médica, Córdoba, Spain"
      ],
      "name": "GM Guevara Madrid"
    },
    {
      "affiliations": [
        "Hospital Universitario Reina Sofía De Córdoba, Oncología Médica, Córdoba, Spain"
      ],
      "name": "M López-Herrero López"
    }
  ],
  "title": "4CPS-255 Real-world use of niraparib in epithelial ovarian cancer",
  "uid": "8a87f3f1-124f-5bdf-9fc2-3491f8dc091a"
}