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 in Japanese patients with heavily pretreated, homologous recombination-deficient ovarian cancer: final results of a multicenter phase 2 study.
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	35(5),pp.e114
著者・共著者	Aoki Daisuke, Tabata Tsutomu, Yanagida Satoshi, Nakamura Toshiaki, Kondo Eiji, Hamanishi Junzo, Harano Kenichi, Hasegawa Kosei, Hirasawa Takeshi, Hori Kensuke, Komiyama Shinichi, Matsuura Motoki, Nakai Hidekatsu, Nakamura Hiroko, Sakata Jun, Takehara Kazuhiro, Takekuma Munetaka, Yokoyama Yoshihito, Kase Yoichi, Sumino Shuuji, Soeda Junpei, Kato Ai, Suri Ajit, Okamoto Aikou, Sugiyama Toru
担当区分	2nd著者
発行年月	2024/09
概要	OBJECTIVE:To evaluate the long-term efficacy and safety of niraparib in Japanese women with heavily pretreated ovarian cancer.METHODS:This was the follow-up analysis of a phase 2, multicenter, open-label, single-arm study in Japanese women with homologous recombination-deficient, platinum-sensitive, relapsed, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who had completed 3-4 lines of chemotherapy and were poly(ADP-ribose) polymerase inhibitor naïve. Participants received niraparib (starting dose, 300 mg) once daily in continuous 28-day cycles until objective disease progression, unacceptable toxicity, or consent withdrawal. The primary endpoint was confirmed objective response rate (ORR), as assessed using Response Evaluation Criteria in Solid Tumors version 1.1. Safety evaluations included treatment-emergent adverse events (TEAEs).RESULTS:20 patients were enrolled in the study and included in both efficacy and safety analyses. Median total study duration was 759.5 days. Median dose intensity was 201.3 mg/day. Confirmed ORR was 60.0% (90% confidence interval [CI]=39.4-78.3); 2 patients had complete response and 10 patients had partial response. Median duration of response was 9.9 months (95% CI=3.9-26.9) and the disease control rate was 90.0% (95% CI=68.3-98.8). The most common TEAEs were anemia (n=15), nausea (n=12), and decreased platelet count (n=11). TEAEs leading to study drug dose reduction, interruption, or discontinuation were reported in 16 (80.0%), 15 (75.0%), and 2 patients (10.0%), respectively.CONCLUSION:The long-term efficacy and safety profile of niraparib was consistent with previous findings in the equivalent population in non-Japanese patients. No new safety signals were identified.TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT03759600.
DOI	10.3802/jgo.2024.35.e114
PMID	39251349