Real-World Experience of Niraparib as Maintenance Therapy in Patients with Newly Diagnosed Advanced Ovarian Cancer: A Single-Center Retrospective Study.

Objective: This study aimed to evaluate the efficacy and safety of niraparib as a maintenance treatment for newly diagnosed advanced ovarian cancer in a real-world setting. Methods: This retrospective observational study included patients with histologically confirmed epithelial ovarian cancer, primary peritoneal or fallopian tube cancer who received niraparib as first-line maintenance therapy at Tianjin Cancer Hospital between January 2021 and January 2023. Clinicopathological characteristics and treatment outcomes were extracted from medical records. The efficacy of niraparib was evaluated by progression-free survival (PFS), and safety was assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Results: A total of 102 patients were enrolled in this study. After a median follow-up of 21.4 months (IQR 20.4-22.5 months), the median PFS was 25.7 months in the overall population, not reached in the BRCA mutation group, and 23.0 months in the wild-type group. A total of fifty patients with a known status of homologous recombination deficiency (HRD) were observed. The median PFS was not reached and 23.0 months in the homologous recombination deficiency and proficient groups, respectively. In the BRCA wild-type group, patients who received more than six cycles of platinum-based chemotherapy had a better prognosis. Furthermore, 20.6% of patients experienced grade 3 or higher treatment-emergent adverse events, while 39.2% experienced treatment interruption, 37.3% underwent dose reduction, and 6.9% discontinued treatment. No new safety signals were observed. Conclusion: In the real-world setting, the use of niraparib as a maintenance treatment for newly diagnosed advanced ovarian cancer has been shown to be effective and well tolerated, which is consistent with the results of previous randomized Phase III trials.