Phase II study of niraparib in recurrent or persistent rare fraction of gynecologic malignancies with homologous recombination deficiency (JGOG2052)

Asano, Hiroshi; Oda, Katsutoshi; Yoshihara, Kosuke; Ito, Yoichi M.; Matsumura, Noriomi; Shimada, Muneaki; Watari, Hidemichi; Enomoto, Takayuki

Phase II study of niraparib in recurrent or persistent rare fraction of gynecologic malignancies with homologous recombination deficiency (JGOG2052)

Asano, Hiroshi; Oda, Katsutoshi; Yoshihara, Kosuke et al.

Journal of gynecologic oncology, 2022, 33(4), e55

Permalink : https://hdl.handle.net/2115/86783

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アクセス権	open access
URI	https://hdl.handle.net/2115/86783
タイトル	Phase II study of niraparib in recurrent or persistent rare fraction of gynecologic malignancies with homologous recombination deficiency (JGOG2052)
著者	Asano, Hiroshi ; Oda, Katsutoshi ; Yoshihara, Kosuke ; Ito, Yoichi M. ; Matsumura, Noriomi ; Shimada, Muneaki ; Watari, Hidemichi ; Enomoto, Takayuki
著者名 Asano, Hiroshi
著者名 Oda, Katsutoshi
著者名 Yoshihara, Kosuke
e-Rad_Researcher 10334236 著者名 Ito, Yoichi M.
著者名 Matsumura, Noriomi
著者名 Shimada, Muneaki
e-Rad_Researcher 10344508 著者名 Watari, Hidemichi
著者名 Enomoto, Takayuki
言語	英語
キーワード	Gynecologic Neoplasms
	Leiomyosarcoma
	Homologous Recombination Repair
	Gene
	Mutation
	Poly(ADP-ribose) Polymerase Inhibitors
発行日	2022-07
出版者	Korean Society of Gynecologic Oncology and Colposcopy
収録物名	Journal of gynecologic oncology
巻(号)	33(4)
ページ	e55
抄録	Background: Poly (adenosine diphosphate)-ribose polymerase (PARP) inhibitors for tumors with homologous recombination deficiency (HRD), including pathogenic mutations in BRCA1/2, have been developed. Genomic analysis revealed that about 20% of uterine leiomyosarcoma (uLMS) have HRD, including 7.5%-10% of BRCA1/2 alterations and 4%-6% of carcinomas of the uterine corpus, and 2.5%-4% of the uterine cervix have alterations of BRCA1/2. Preclinical and clinical case reports suggest that PARP inhibitors may be effective against those targets. The Japanese Gynecologic Oncology Group (JGOG) is now planning to conduct a new investigator-initiated clinical trial, JGOG2052. Methods: JGOG2052 is a single-arm, open-label, multi-center, phase 2 clinical trial to evaluate the efficacy and safety of niraparib monotherapy for a recurrent or persistent rare fraction of gynecologic malignancies with BRCA1/2 mutations except for ovarian cancers. We will independently consider the effect of niraparib for uLMS or other gynecologic malignancies with BRCA1/2 mutations (cohort A, C) and HRD positive uLMS without BRCA1/2 mutations (cohort B). Participants must have 1-3 lines of previous chemotherapy and at least one measurable lesion according to RECIST (v.1.1). Niraparib will be orally administered once a day until lesion exacerbation or unacceptable adverse events occur. Efficacy will be evaluated by imaging through an additional computed tomography scan every 8 weeks. Safety will be measured weekly in cycle 1 and every 4 weeks after cycle 2 by blood tests and physical examinations. The sample size is 16-20 in each of cohort A and B, and 31 in cohort C. Primary endpoint is the objective response rate.
資源タイプ	学術雑誌論文
出版タイプ	Version of Record
PISSN	2005-0380
関連情報 (isIdenticalTo)	出版社版DOI https://doi.org/10.3802/jgo.2022.33.e55