J Gynecol Oncol.  2024 Sep;35(5):e115. 10.3802/jgo.2024.35.e115.

Niraparib in Japanese patients with platinum-sensitive recurrent ovarian cancer: final results of a multicenter phase 2 study

• Itamochi H
• Takeshima N
• Hamanishi J
• Hasegawa K
• Matsuura M
• Miura K
• Nagao S
• Nakai H
• Tanaka N
• Tokunaga H
• Nishio S
• Watari H
• Yokoyama Y
• Kase Y
• Sumino S
• Kato A
• Suri A
• Yasuoka T
• Takehara K

• KMID: 2564944
• DOI: http://doi.org/10.3802/jgo.2024.35.e115

Abstract

Objective
This study evaluated the long-term safety and efficacy of niraparib in Japanese patients with platinum-sensitive recurrent ovarian cancer.
Methods
This was a follow-up analysis of a phase 2, multicenter, open-label, single-arm study in Japanese women with platinum-sensitive, relapsed ovarian cancer. Participants received niraparib (starting dose 300 mg) once daily in continuous 28-day cycles. The primary endpoint was the incidence of Grade 3 or 4 thrombocytopenia-related events (defined as the overall incidence of the MedDRA Preferred Terms “thrombocytopenia” and “platelet count decreased”) occurring in the 30 days after initial administration of niraparib, and secondary endpoints included evaluation of treatment-emergent adverse events and progression-free survival.
Results
Nineteen patients (median age, 62 years; median body weight, 53.9 kg) were enrolled. As previously reported, the incidence of Grade 3 or 4 thrombocytopenia-related events during the first 30 days of treatment was 31.6%. At data cutoff, median (range) treatment exposure was 504.0 (56–1,054) days and mean ± standard deviation dose intensity was 154.4±77.5 mg/day. The most common treatment-emergent adverse events were nausea (n=14, 73.7%), decreased platelet count (n=12, 63.2%), decreased neutrophil count (n=11, 57.9%), anemia, vomiting, and decreased appetite (all n=9, 47.4%). One patient was diagnosed with treatment-related leukemia, which resulted in death. Median (95% confidence interval) progression-free survival was 18.0 (5.6–26.7) months.
Conclusion
Overall, the safety profile of niraparib was considered manageable in this study population of Japanese patients with platinum-sensitive, relapsed ovarian cancer and was consistent with that observed in studies of non-Japanese patients.

Keyword

Clinical Trial, Phase II; Poly(ADP-ribose) Polymerase Inhibitors; Ovarian Cancer