Real-world outcomes of first-line maintenance niraparib monotherapy in patients with epithelial ovarian cancer
Creators: name: Salani, Ritu
name: Boyle, Tirza Areli Calderón
name: Lim, Jonathan
name: Schilder, Jeanne M.
name: Hurteau, Jean A.
name: Perhanidis, Jessica
name: Golembesky, Amanda
name: Backes, Floor J.
Publisher: name: Taylor & Francis
Year: 2025
Subjects: subject: Medicine
subject: Cell Biology
subject: Pharmacology
subject: Immunology
subject: FOS: Clinical medicine
subject: Cancer

description: To assess real-world progression-free survival (rwPFS) and time to next treatment (rwTTNT) among patients with epithelial ovarian cancer (EOC) who received first-line maintenance (1LM) niraparib monotherapy. In this US-nationwide, electronic health record–derived, deidentified database study, eligible patients with EOC initiated 1LM niraparib monotherapy (1 January 2017–1 December 2022) following first-line platinum-based chemotherapy. Median rwPFS and rwTTNT were estimated with Kaplan–Meier methodology overall and in a homologous recombination-deficient (HRd) subgroup (further stratified as <i>BRCA</i> wild-type [<i>BRCA</i>wt] or <i>BRCA</i>-mutated [<i>BRCA</i>m]). Observed median rwPFS was 11.4 (95% CI, 10.1–12.7) months overall (<i>N</i> = 560), 18.2 (95% CI, 13.9–24.2) months for the HRd subgroup (<i>n</i> = 144), and 25.4 (95% CI, 15.9–not reached) and 14.2 (95% CI, 8.6–18.6) months for HRd patients with <i>BRCA</i>m and <i>BRCA</i>wt tumors, respectively. Observed median rwTTNT was 12.4 (95% CI, 11.5–13.8) months overall, 19.6 (95% CI, 14.9–23.9) months for the HRd subgroup, and 24.9 (95% CI, 16.0–not reached) and 15.1 (95% CI, 10.3–19.8) months for HRd patients with <i>BRCA</i>m and <i>BRCA</i>wt tumors, respectively. The real-world observed median rwPFS and rwTTNT were longer for patients with EOC who received 1LM niraparib monotherapy in the HRd subgroup (specifically for the <i>BRCA</i>m subgroup). <b>What is this article about?</b> In the PRIMA clinical trial, niraparib, a medicine used to treat epithelial ovarian cancer (EOC) after platinum-based chemotherapy, was shown to extend the amount of time a patient has before the cancer worsens or before the patient dies. It is unknown whether patients with EOC in the real-world, outside the clinical trial setting, will experience the same benefit (cancer not worsening/not dying) from taking niraparib after platinum-based chemotherapy. <b>What were the results?</b> We found that patients with EOC who received niraparib, after platinum-based chemotherapy, lived about 11 months without their cancer worsening or dying and lived about 12 months without needing to take another treatment. For a subgroup of patients whose tumors had a specific type of changes in their cancer cells, called homologous recombination-deficient (HRd) cells, patients lived about 18 months without their cancer worsening or dying and lived about 20 months before taking another treatment. When looking at this HRd subgroup even further, patients with HRd cells with a <i>BRCA</i> gene mutation, lived about 25 months without their cancer worsening or dying and lived about 25 months before taking another treatment. <b>What do the results mean?</b> In the real-world, outcomes were longer for patients with EOC whose tumors had HRd cells and specifically for those with HRd cells with a <i>BRCA</i> mutation. These real-world findings are consistent with clinical trial results.