Department of Clinical Oncology, Iwate Medical University School of Medicine, Yahaba, Japan.
Department of Obstetrics and Gynecology, International University of Health and Welfare Hospital, Nasushiobara, Japan.
J Gynecol Oncol. 2024 Sep;35(5):e115. doi: 10.3802/jgo.2024.35.e115. Epub 2024 Jul 17.
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.
本研究评估尼拉帕利在日本铂类敏感复发性卵巢癌患者中的长期安全性和疗效。
这是一项在日本铂类敏感、复发卵巢癌女性中进行的 2 期、多中心、开放标签、单臂研究的随访分析。参与者接受尼拉帕利（起始剂量 300mg）每日一次，连续 28 天为一个周期。主要终点为尼拉帕利初始给药后 30 天内发生的 3 级或 4 级血小板减少相关事件的发生率（定义为 MedDRA 首选术语“血小板减少”和“血小板计数降低”的总发生率），次要终点包括评价治疗出现的不良事件和无进展生存期。
19 名患者（中位年龄 62 岁；中位体重 53.9kg）入组。如前所述，治疗的前 30 天内发生 3 级或 4 级血小板减少相关事件的发生率为 31.6%。数据截止时，中位（范围）治疗暴露时间为 504.0（56-1054）天，平均±标准偏差剂量强度为 154.4±77.5mg/天。最常见的治疗出现的不良事件是恶心（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（均 n=9，47.4%）。1 例患者被诊断为治疗相关性白血病，导致死亡。中位（95%置信区间）无进展生存期为 18.0（5.6-26.7）个月。
总体而言，尼拉帕利在本研究中日本铂类敏感、复发性卵巢癌患者人群中的安全性特征是可控的，与非日本患者研究中观察到的安全性特征一致。
ClinicalTrials.gov 标识符：NCT03759587。
