目的:上皮性卵巢癌(EOC)是妇科恶性肿瘤女性死亡的主要原因,在日本发病率上升。本研究旨在验证尼拉帕尼在日本临床实践中作为初始化疗后EOC维持治疗的治疗模式和安全性。
方法:利用2008年4月至2022年12月的索赔数据,这项描述性研究包括接受初始铂类化疗的EOC诊断患者,减积手术,和尼拉帕尼作为维持治疗。患者特征,处方状态,输血细节,和实验室数据被评估和报告为汇总统计数据和频率.
结果:在291名患者中,中位年龄为64.0岁,94.5%接受每日200mg尼拉帕尼.在第12周,78.7%(229/291)继续尼拉帕尼治疗,21.3%(62/291)停产,52.2%(152/291)需要治疗中断。在停止治疗的62名患者中,尼拉帕尼停药后12周内,有27例患者开始了随后的EOC治疗。10.3%(30/291)需要输血,在55名具有实验室数据的患者中,61.8%(34/55)的血小板计数下降<100,000/微升,25.5%(14/55)的血红蛋白水平降低<8g/dL,22.7%(5/22)的中性粒细胞计数下降<1,000/微升,符合治疗中断的标准。在血小板减少症患者中,88.2%(30/34)能够恢复或继续治疗。
结论:尼拉帕尼在日本晚期EOC患者中表现出良好的耐受性,通过剂量调整和支持治疗有效管理血小板减少症,支持其作为化疗后维持治疗的可行性。
OBJECTIVE: Epithelial ovarian cancer (EOC) is the leading cause of female mortality in gynecologic malignancies, with a rising incidence in Japan. This study aimed to validate the treatment patterns and safety of niraparib as maintenance therapy for EOC following initial chemotherapy in clinical practice in Japan.
METHODS: Leveraging claims data between April 2008 and December 2022, this descriptive study comprised EOC-diagnosed patients receiving initial platinum-based chemotherapy, debulking surgery, and niraparib as maintenance therapy. Patient characteristics, prescription status, transfusion details, and laboratory data were assessed and reported as summary statistics and frequencies.
RESULTS: Among 291 patients, the median age was 64.0 years and 94.5% received a 200-mg daily dose of niraparib. At week 12, 78.7% (229/291) continued niraparib treatment, 21.3% (62/291) discontinued, and 52.2% (152/291) required treatment interruptions. Of the 62 patients who discontinued treatment, 27 patients initiated subsequent EOC treatment within 12 weeks following niraparib discontinuation. Blood transfusions were needed in 10.3% (30/291), and of 55 patients with available laboratory data, 61.8% (34/55) had decreased platelet count <100,000/µL, 25.5% (14/55) had decreased hemoglobin level <8 g/dL, and 22.7% (5/22) had decreased neutrophil count <1,000/µL, meeting the criteria for treatment interruption. Among those with thrombocytopenia, 88.2% (30/34) were able to either resume or continue treatment.
CONCLUSIONS: Niraparib demonstrated favorable tolerability in Japanese patients with advanced EOC, with effective management of thrombocytopenia through dose adjustments and supportive care, supporting its viability as post-chemotherapy maintenance therapy.