# Real-life observational study on niraparib in older patients with primary tubo-ovarian cancer: a focus on safety and efficacy

## TL;DR

This study examines the safety and effectiveness of niraparib in older patients with tubo-ovarian cancer, finding it well-tolerated and effective.

## Contribution

The study provides real-world evidence on the safety and efficacy of niraparib in older patients with tubo-ovarian cancer.

## Key findings

- Niraparib is safe and well-tolerated in patients aged ≥75 years.
- There were no significant differences in adverse events between age groups.
- Progression-free survival was similar across all age groups.

## Abstract

Niraparib is approved for maintenance treatment of tubo-ovarian cancer patients, but data on older patients are limited. This retrospective study evaluated its safety and efficacy in primary advanced tubo-ovarian cancer, focusing on patients ≥ 75 years.

Women aged ≥ 50 years diagnosed with primary high-grade serous tubo-ovarian cancer, treated with niraparib between 2019–2023, were enrolled. Patients were stratified into three groups: A (50–64 years), B (65–74 years), and C (≥ 75 years). The primary outcome was progression-free survival. The secondary outcomes were toxicity and dose reduction.

127 patients were identified: 62 (48.8%) group A, 26 (20.5%) group B, and 39 (30.7%) group C. Baseline characteristics were comparable across groups, excluding a higher proportion of interval cytoreductive surgeries (p = 0.001), residual tumor (p = 0.01) and Eastern Cooperative Oncology Group (ECOG) > 1 (p = 0.01) in group C. Most patients started niraparib at 200 mg/day with dose reductions primarily occurred within fourth cycle. Dose reductions were observed in 77.4%, 69.2% and 56.4% of patients in groups A, B, and C, respectively (p = 0.08). In patients ≥ 75 years, 26 (66.7%) discontinued treatment due to disease progression (48.7%) or toxicity (17.9%). There were no significant differences in common or grade ≥ 3 adverse events between groups. Progression-free survival was 12 months (95%CI: 2.0–25.0) for group A, 29 months (95%CI: 11.0–52.0) for group B, and 16 months (95%CI: 1.0–31.0) for group C (p = 0.78).

Our findings suggest that niraparib is safe and well-tolerated in aged ≥ 75 years. Concerns about toxicity should not preclude the enrollment of elderly patients in treatment regiments.

The online version contains supplementary material available at 10.1007/s10147-025-02914-y.