Ovarian cancer remains one of the most lethal gynaecologic malignancies worldwide, with a high risk of recurrence even after successful initial treatment.

Over the past decade, poly(ADP-ribose) polymerase (PARP) inhibitors have transformed first-line maintenance therapy by significantly prolonging disease control.

While randomised clinical trials have established the efficacy of these agents, prospective real-world evidence has remained limited, particularly in Asian populations.

To address this gap, investigators conducted the RENI-1 study, the first prospective, multicenter real-world study of niraparib maintenance therapy in newly diagnosed ovarian cancer in China.

The study enrolled 227 patients across 22 hospitals nationwide, creating one of the largest prospective real-world datasets of niraparib maintenance therapy reported in China to date.

This paper was published in the Chinese Medical Journal.

After a median follow-up of 41.5 months, RENI-1 demonstrated durable and clinically meaningful outcomes.

Median PFS reached 36.5 months in the intention-to-treat population.

Among patients with FIGO stage III–IV disease, median PFS was 25.4 months, consistent with outcomes reported in pivotal clinical trials.

Median PFS was not reached in patients harbouring BRCA1/2 mutations or homologous recombination deficiency (HRD), indicating sustained long-term benefit in these biomarker-defined populations.

Importantly, more than half of patients with BRCA1/2 mutations remained on niraparib treatment for at least three years, highlighting the feasibility of long-term maintenance therapy in routine clinical practice.

Real-world treatment patterns further supported the practicality of niraparib use.

Most patients-initiated maintenance therapy within 12 weeks after completing chemotherapy and received niraparib monotherapy.

Clinical outcomes were generally consistent across subgroups defined by prior bevacizumab exposure, dose modifications, and comorbidity status, suggesting that niraparib can be effectively used in a broad range of patients encountered in everyday practice.

Exploratory analyses identified several factors associated with prolonged PFS, including postoperative R0 resection, primary debulking surgery, complete response to chemotherapy, BRCA1/2 mutation, and HRD positivity.

These findings may help clinicians better identify patients who are most likely to derive long-term benefit from niraparib maintenance therapy.

The safety profile observed in RENI-1 was consistent with previous clinical studies.

Most treatment-related adverse events occurred during the first three months of treatment and were manageable with routine clinical interventions.

No new safety signals were identified.

Patient-reported outcomes remained stable throughout treatment, indicating that prolonged niraparib maintenance did not adversely affect overall quality of life.

As the first prospective real-world study of niraparib maintenance therapy in China, RENI-1 provides important evidence bridging the gap between randomised clinical trials and routine clinical practice.

The study confirms that the long-term efficacy, safety, and quality-of-life benefits of niraparib can be achieved in a broad and unselected patient population.

These findings support the continued use of niraparib as a standard first-line maintenance therapy and provide important real-world evidence to guide treatment decision-making and optimise ovarian cancer care.

Source: Chinese Medical Journals Publishing House Co., Ltd.