Objective: The objective of this study was to present the real-world patients’ portrait, and the results of niraparib treatment in China.
Methods: This study included 142 patients treated with niraparib from 8 hospitals in China between December 2018 and September 2021. Patients’ characteristics were summarized. The efficacy and safety in first-line maintenance (1L-M), platinum-sensitive recurrence maintenance (PSR-M), and treatment for ovarian cancer were evaluated. Survival outcomes and the factors influencing progression-free survival (PFS) were estimated.
Results: The 93 patients received Niraparib as 1L-M, 31 as PSR-M and 18 as salvage. BRCA status was wild type or unknown in 87.3% of patients. With a median follow-up time of 8.7 months, the median PFS (mPFS) for 1L-M has not yet been reached, and the mPFS for PSR-M and salvage therapy was 10.5 and 5.7 months, respectively. Responses to last chemotherapy and cancer antigen 125 value before taking niraparib were 2 important factors affecting PFS among 1L and PSR patients. The 12.7% (18/142) of patients experienced grade ≥3 hematologic adverse events and 23.2% experienced dose adjustment. It was noteworthy that when the interval of chemotherapy and niraparib <21 days, the incidence of grade ≥3 adverse events increased significantly (p=0.0355).
Conclusion: Generally, niraparib was effective and well tolerated, which was consistent with the results of prospective trials. However, in real world, it was more inclined to use niraparib in late-line treatment without genetic testing.
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