タバタ ツトム   TABATA Tsutomu
  田畑 務
   所属   医学部 医学科(東京女子医科大学病院)
   職種   教授・基幹分野長
論文種別 症例報告
言語種別 英語
査読の有無 査読あり
表題 Niraparib as maintenance therapy in Japan: a retrospective observational study using a Japanese claims database.
掲載誌名 正式名:Journal of gynecologic oncology
略  称:J Gynecol Oncol
ISSNコード:20050399/20050380
掲載区分国外
巻・号・頁 36(2),pp.e19-e19
著者・共著者 Motohashi Takashi, Shimada Muneaki, Tokunaga Hideki, Kuwahara Yuki, Kuwabara Hiroyo, Kato Ai, Tabata Tsutomu
担当区分 最終著者
発行年月 2024/07
概要 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.CONCLUSION: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.
DOI 10.3802/jgo.2025.36.e19
PMID 39028152