本研究评估了尼拉帕尼在日本铂类敏感复发性卵巢癌患者中的长期安全性和有效性。这是一项针对日本女性铂类药物的 2 期、多中心、开放标签、单组研究的后续分析-敏感的、复发性卵巢癌。参与者每天接受一次 niraparib（起始剂量 300 mg），连续 28 天为一个周期。主要终点是首次给予 niraparib 后 30 天内发生的 3 级或 4 级血小板减少相关事件（定义为 MedDRA 首选术语“血小板减少”和“血小板计数减少”的总体发生率），以及次要终点包括对治疗中出现的不良事件和无进展生存期的评估。纳入了 19 名患者（中位年龄，62 岁；中位体重，53.9 kg）。如之前报道，治疗前 30 天内 3 级或 4 级血小板减少相关事件的发生率为 31.6%。在数据截止时，中位（范围）治疗暴露时间为 504.0（56-1,054）天，平均±标准偏差剂量强度为 154.4±77.5 毫克/天。最常见的治疗引起的不良事件是恶心（n=14，73.7%）、血小板计数减少（n=12，63.2%）、中性粒细胞计数减少（n=11，57.9%）、贫血、呕吐和食欲下降（所有 n=9，47.4%）。一名患者被诊断患有与治疗相关的白血病，导致死亡。中位无进展生存期（95% 置信区间）为 18.0 (5.6-26.7) 个月。 总体而言，尼拉帕尼的安全性在本次日本铂敏感复发性卵巢癌患者研究人群中被认为是可控的，并且与在非日本患者的研究中观察到。ClinicalTrials.gov 标识符：NCT03759587.© 2024。亚洲妇科肿瘤学会、韩国妇科肿瘤学会和日本妇科肿瘤学会。

This study evaluated the long-term safety and efficacy of niraparib in Japanese patients with platinum-sensitive recurrent ovarian cancer.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.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.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.ClinicalTrials.gov Identifier: NCT03759587.© 2024. Asian Society of Gynecologic Oncology, Korean Society of Gynecologic Oncology, and Japan Society of Gynecologic Oncology.