Treatment With Niraparib Maintenance Therapy in Patients With Newly Diagnosed Advanced Ovarian Cancer

Rákkutatás · Ovarian cancer

In the PRIME phase 3 randomized clinical trial of 384 patients with newly diagnosed advanced ovarian cancer after receiving first‑line platinum‑based chemotherapy, treatment with niraparib with an individualized starting dose significantly extended progression‑free survival vs placebo and reduced the risk of disease progression or death by 55%.

This phase 3, double‑blind, placebo‑controlled randomized clinical trial evaluated the efficacy and safety of niraparib with an individualized starting dose (ISD) as maintenance therapy in 384 Chinese patients with newly diagnosed advanced ovarian cancer who had received primary or interval debulking surgery and first‑line platinum‑based chemotherapy. Patients were randomized 2:1 to niraparib or matched placebo. The primary endpoint was progression‑free survival (PFS) assessed by blinded independent central review. Median PFS in the intention‑to‑treat population was 24.8 months with niraparib vs 8.3 months with placebo (hazard ratio = 0.45; 95% CI = 0.34‑0.60; P < 0.001). Improvements were consistent across subgroups defined by germline BRCA status, homologous recombination deficiency, and postoperative residual disease status. The treatment was generally well tolerated, with similar rates of discontinuation due to adverse events.

The results support the use of niraparib monotherapy as a standard of care after first‑line platinum‑based chemotherapy in a broad patient population with advanced ovarian cancer, irrespective of biomarker status or residual disease.

Bizonyítékszint: Irányelv / elfogadott gyakorlat. Magas szintű klinikai elfogadottság.

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