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논문 기본 정보

자료유형
학술저널
저자정보
Daisuke Aoki (International University of Health and Welfare Graduate School, Tokyo, Japan) Aikou Okamoto (The Jikei University School of Medicine) Tsutomu Tabata (Tokyo Women’s Medical University, Tokyo, Japan) Satoshi Yanagida (The Jikei University School of Medicine) Toshiaki Nakamura (Kagoshima City Hospital) Eiji Kondo (Department of Obstetrics and Gynecology, Mie University Graduate School of Medicine, Mie, Japan) Junzo Hamanishi (Department of Gynecology and Obstetrics, Kyoto University Graduate School of Medicine, Kyoto, Japan) Kenichi Harano (Department of Medical Oncology, National Cancer Center Hospital East, Kashiwa, Japan) Kosei Hasegawa (Department of Gynecologic Oncology, Saitama Medical University International Medical Center, Saitama, Japan) Takeshi Hirasawa (Department of Obstetrics and Gynecology, Tokai University School of Medicine, Isehara, Japan) Kensuke Hori (Department of Obstetrics and Gynecology, Kansai Rosai Hospital, Amagasaki, Japan)
저널정보
대한부인종양학회 Journal of Gynecologic Oncology Journal of Gynecologic Oncology Vol.35 No.5
발행연도
2024.9
수록면
1 - 12 (12page)
DOI
https://doi.org/10.3802/jgo.2024.35.e115

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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. Trial Registration: ClinicalTrials.gov Identifier: NCT03759587
#Clinical Trial #Phase II #Poly(ADP-ribose) Polymerase Inhibitors #Ovarian Cancer

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