尼拉帕尼在日本作为维持治疗:一项使用日本索赔数据库的回顾性观察研究。
Niraparib as maintenance therapy in Japan: a retrospective observational study using a Japanese claims database.
发表日期:2024 Jul 04
作者:
Takashi Motohashi, Muneaki Shimada, Hideki Tokunaga, Yuki Kuwahara, Hiroyo Kuwabara, Ai Kato, Tsutomu Tabata
来源:
Journal of Gynecologic Oncology
摘要:
上皮性卵巢癌(EOC)是女性妇科恶性肿瘤死亡的主要原因,在日本发病率不断上升。本研究旨在验证日本临床实践中初始化疗后尼拉帕利作为 EOC 维持治疗的治疗模式和安全性。这项描述性研究利用 2008 年 4 月至 2022 年 12 月期间的索赔数据,包括接受初始铂类化疗的诊断为 EOC 的患者、减瘤手术和尼拉帕尼作为维持治疗。对患者特征、处方状态、输血细节和实验室数据进行评估,并以汇总统计数据和频率的形式报告。在 291 名患者中,中位年龄为 64.0 岁,94.5% 接受每日 200 mg 剂量的尼拉帕尼。第 12 周时,78.7% (229/291) 的患者继续尼拉帕尼治疗,21.3% (62/291) 的患者停止治疗,52.2% (152/291) 的患者需要中断治疗。在停止治疗的 62 名患者中,27 名患者在尼拉帕尼停药后 12 周内开始后续 EOC 治疗。 10.3% (30/291) 需要输血,在 55 名有可用实验室数据的患者中,61.8% (34/55) 的血小板计数降低 <100,000/μL,25.5% (14/55) 的血红蛋白水平降低 <100,000/μL。 8 g/dL 和 22.7% (5/22) 的中性粒细胞计数减少<1,000/μL,符合治疗中断的标准。在患有血小板减少症的患者中,88.2% (30/34) 能够恢复或继续治疗。尼拉帕尼在患有晚期 EOC 的日本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,支持其在治疗后的生存能力。化疗维持治疗。© 2025。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。
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.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.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.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.© 2025. Asian Society of Gynecologic Oncology, Korean Society of Gynecologic Oncology, and Japan Society of Gynecologic Oncology.