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	原著
言語種別	英語
査読の有無	査読あり
表題	Phase 2 single-arm study on the efficacy and safety of niraparib in Japanese patients with heavily pretreated, homologous recombination-deficient ovarian cancer.
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	32(2),pp.e16
著者・共著者	Okamoto Aikou, Kondo Eiji, Nakamura Toshiaki, Yanagida Satoshi, Hamanishi Junzo, Harano Kenichi, Hasegawa Kosei, Hirasawa Takeshi, Hori Kensuke, Komiyama Shinichi, Matsuura Motoki, Nakai Hidekatsu, Nakamura Hiroko, Sakata Jun, Tabata Tsutomu, Takehara Kazuhiro, Takekuma Munetaka, Yokoyama Yoshihito, Kase Yoichi, Sumino Shuuji, Soeda Junpei, Suri Ajit, Aoki Daisuke, Sugiyama Toru
発行年月	2021/03
概要	OBJECTIVE:To evaluate the efficacy and safety of niraparib in Japanese women with heavily pretreated ovarian cancer.METHODS:This Phase 2 open-label, single-arm study enrolled Japanese women with homologous recombination deficiency-positive relapsed, high-grade serous ovarian, fallopian tube, or primary peritoneal cancer who had completed 3-4 lines of therapy. The starting dose of niraparib was 300 mg administered once daily in continuous 28-day cycles until objective progressive disease, unacceptable toxicity, consent withdrawal or discontinuation. The primary endpoint, objective response rate (ORR), was assessed by the investigator using RECIST version 1.1. Safety evaluations included the incidence of treatment-emergent adverse events (TEAEs), including serious TEAEs.RESULTS:Twenty women were enrolled and the confirmed ORR in the full analysis set (FAS) was 35.0% (7/20), consisting of 1 complete response and 6 partial responses. Disease control rate in the FAS was 90.0%. The most frequently reported TEAEs (>50%) were anemia, nausea, and platelet count decreased. One patient (5.0%) had TEAEs leading to discontinuation of niraparib whereas reductions or interruptions were reported in 14 (70.0%) and 15 (75.0%) patients, respectively. The median dose intensity (202.9 mg daily) corresponded to a relative dose intensity of 67.6%.CONCLUSION:Efficacy and safety of niraparib in heavily pretreated Japanese women was comparable to that seen in an equivalent population of non-Japanese women. No new safety signals were identified.TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT03759600.
DOI	10.3802/jgo.2021.32.e16
PMID	33327047