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Abstract
Introduction/Background Niraparib is a Poly (ADP-ribose) polymerase inhibitor (PARP-I) approved for the maintenance in primary advanced ovarian cancer (AOC) and recurrent platinum-sensitive ovarian cancer (ROC). More than half of patients are supposed to reduce dose during treatment, but it is unknown if side effects occur more commonly in AOC or ROC; also, the impact of Niraparib dose reduction on survival has rarely been investigated.
Methodology This study includes women with primary (AOC group) or recurrent (ROC group) high-grade serous ovarian cancer in maintenance with Niraparib between 2019–2022. Niraparib dosing was based on described individualized starting dose of 200mg/day or 300mg/day for those with a weight ≥ 77 kg and platelet count ≥ 150,000/μL. The primary outcome was the impact of Niraparib dose reductions on progression-free survival (PFS), in AOC and ROC separately. The secondary outcome was the comparison of reduction rates between the two groups.
Results 215 Niraparib-treated patients, 124 (57.7%) with AOC and 91 (42.3%) with ROC, were included. The majority of patients started Niraparib at 200mg/day (87.4%), in the both groups; most of reductions occurred within the first 4 cycles (figure 1A,B); dose reductions from 200 to 100mg/day occurred more frequently in AOC compared with ROC (35.9% vs 7.5%, p<0.001).
PFS was estimated in case of treatment longer than 12 weeks, to avoid biases; therefore, analysis focused on patients treated with 200mg or 100mg. In AOC, median PFS was 28 months for 200 mg compared with Not Reached for 100 mg (p=0.49; figure 1C). Similarly, among ROC, median PFS was not significantly affected by the dose (100mg 17 months vs 200mg Not Reached, p=0.31) (figure 1D).
Conclusion Niraparib dose reduction occurs in almost half of patients within 30 days, regardless of disease setting, albeit it’s significantly more common in first-line setting. Survival outcomes seem not to be impaired by dose reduction.
Disclosures none