Niraparib Maintenance Therapy in Platinum-Sensitive, Recurrent Ovarian Cancer
In patients with platinum-sensitive, recurrent ovarian cancer, maintenance therapy with niraparib significantly prolongs progression‑free survival relative to placebo regardless of germline BRCA mutation or homologous recombination deficiency status.
Background: Niraparib, an oral PARP1/2 inhibitor, shows activity in ovarian cancer. Objective: To evaluate efficacy of niraparib versus placebo as maintenance treatment for patients with platinum‑sensitive, recurrent ovarian cancer. Methods: Randomized, double‑blind, phase 3 trial with germline BRCA (gBRCA) and non‑gBRCA cohorts, 2:1 randomization to niraparib 300 mg or placebo, primary endpoint progression‑free survival (PFS). Results: Among 553 enrolled, 203 were gBRCA (138 niraparib, 65 placebo) and 350 non‑gBRCA (234 niraparib, 116 placebo). Niraparib prolonged median PFS: 21.0 vs 5.5 mo in gBRCA cohort (HR 0.27), 12.9 vs 3.8 mo for HRD‑positive non‑gBRCA (HR 0.38), and 9.3 vs 3.9 mo overall (HR 0.45). Common grade 3/4 adverse events: thrombocytopenia (33.8 %), anemia (25.3 %), neutropenia (19.6 %). Conclusion: Niraparib significantly extends PFS in platinum‑sensitive, recurrent ovarian cancer irrespective of gBRCA or HRD status, with manageable bone‑marrow toxicity.
Prolonging disease control in recurrent ovarian cancer improves patient outcomes and offers a therapeutic option for high‑risk, platinum‑responsive disease. Niraparib’s efficacy across genetic subgroups expands personalized care for patients with DNA‑repair deficiencies.
Evidence level: Irányelv / elfogadott gyakorlat. Magas szintű klinikai elfogadottság.
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