Pamiparib Monotherapy for Patients with Germline BRCA1/2-Mutated Ovarian Cancer Previously Treated with at Least Two Lines of Chemotherapy: A Multicenter, Open-Label, Phase II Study

doi:10.1158/1078-0432.CCR-21-1186

	Pamiparib Monotherapy for Patients with Germline BRCA1/2-Mutated Ovarian Cancer Previously Treated with at Least Two Lines of Chemotherapy: A Multicenter, Open-Label, Phase II Study
	Wu, Xiaohua 2; Zhu, Jianqing 3; Wang, Jing 4; Lin, Zhongqiu 5; Yin, Rutie 6; Sun, Wei 7; Zhou, Qi 8,9,10; Zhang, Songling 11; Wang, Danbo 12; Shi, Hong 13
刊名	CLINICAL CANCER RESEARCH
	2022-02-15
卷号	28
ISSN号	1078-0432
DOI	10.1158/1078-0432.CCR-21-1186
通讯作者	Wu, Xiaohua(wu.xh@fudan.edu.cn)
英文摘要	Purpose: Phase I results of this phase I/II study showed that pamiparib 60 mg twice a day had antitumor activity and an acceptable safety profile in Chinese patients with advanced cancer, including epithelial ovarian cancer. Patients and Methods: This open-label phase II study was con-ducted in China and enrolled adult (>= 18 years) patients with plat-inum-sensitive ovarian cancer (PSOC; disease progression occurring >= 6 months after last platinum treatment) or platinum-resistant ovarian cancer (PROC; disease progression occurring <6 months after last platinum treatment). Eligible patients had known or sus-pected deleterious germline BRCA mutation (gBRCA(mut)) and had previously received >= 2 lines of therapy. Pamiparib 60 mg orally twice day was administered until disease progression, toxicity, or patient withdrawal. The primary endpoint was objective response rate (ORR) assessed by independent review committee (IRC) per RECIST version 1.1. Results: In the total patient population (N = 113; PSOC, n = 90; PROC, n = 23), median age was 54 years (range, 34-79) and 25.6% of patients received >= 4 prior systemic chemotherapy lines. Median study follow-up was 12.2 months (range, 0.2-21.5). Eighty-two patients with PSOC and 19 patients with PROC were evaluable for efficacy. In patients with PSOC, 8 achieved a complete response (CR) and 45 achieved a partial response (PR); ORR was 64.6% [95% confidence interval (CI), 53.3-74.9]. In patients with PROC, 6 achieved a PR; ORR was 31.6% (95% CI, 12.6-56.6). Frequently reported grade >= 3 adverse events were hematologic toxicities, including anemia and decreased neutro-phil count. Conclusions: Pamiparib 60 mg twice a day showed antitumor activity with durable responses in patients with PSOC or PROC with gBRCA(mut), and had a manageable safety profile.
资助项目	BeiGene, Ltd.
WOS关键词	SELECTIVE PARP INHIBITOR ; ANTITUMOR-ACTIVITY ; BRCA2 MUTATION ; OLAPARIB ; SAFETY ; CARCINOMA ; RUCAPARIB ; POTENT
WOS研究方向	Oncology
语种	英语
出版者	AMER ASSOC CANCER RESEARCH
WOS记录号	WOS:000756668200001
资助机构	BeiGene, Ltd.
内容类型	期刊论文
源URL	[http://ir.hfcas.ac.cn:8080/handle/334002/127909]
专题	中国科学院合肥物质科学研究院
通讯作者	Wu, Xiaohua
作者单位	1.Huazhong Univ Sci & Technol, Hubei Canc Hosp, Tongji Med Coll, Dept Gynecol Oncol, Wuhan, Peoples R China 2.Fudan Univ, Dept Gynecol Oncol, Shanghai Canc Ctr, Shanghai 200032, Peoples R China 3.Univ Chinese Acad Sci, Dept Gynecol Oncol, Zhejiang Canc Hosp, Canc Hosp, Hangzhou, Peoples R China 4.Cent South Univ, Hunan Canc Hosp, Dept Gynecol & Oncol, Affiliated Canc Hosp,Xiangya Sch Med, Changsha, Peoples R China 5.Sun Yat Sen Univ, Sun Yat Sen Mem Hosp, Dept Gynecol Oncol, Guangzhou, Peoples R China 6.Sichuan Univ, Key Lab Birth Defects & Related Dis Women & Child, West China Hosp 2, Dept Obstet & Gynecol,Minist Educ, Chengdu, Peoples R China 7.Anhui Prov Canc Hosp, Affiliated Hosp USTC 1, Dept Gynecol Oncol, Hefei, Peoples R China 8.Chongqing Univ, Dept Gynecol Oncol, Canc Hosp, Chongqing, Peoples R China 9.Chongqing Canc Inst, Chongqing, Peoples R China 10.Chongqing Canc Hosp, Chongqing, Peoples R China
推荐引用方式 GB/T 7714	Wu, Xiaohua,Zhu, Jianqing,Wang, Jing,et al. Pamiparib Monotherapy for Patients with Germline BRCA1/2-Mutated Ovarian Cancer Previously Treated with at Least Two Lines of Chemotherapy: A Multicenter, Open-Label, Phase II Study[J]. CLINICAL CANCER RESEARCH,2022,28.
APA	Wu, Xiaohua.,Zhu, Jianqing.,Wang, Jing.,Lin, Zhongqiu.,Yin, Rutie.,...&Kong, Beihua.(2022).Pamiparib Monotherapy for Patients with Germline BRCA1/2-Mutated Ovarian Cancer Previously Treated with at Least Two Lines of Chemotherapy: A Multicenter, Open-Label, Phase II Study.CLINICAL CANCER RESEARCH,28.
MLA	Wu, Xiaohua,et al."Pamiparib Monotherapy for Patients with Germline BRCA1/2-Mutated Ovarian Cancer Previously Treated with at Least Two Lines of Chemotherapy: A Multicenter, Open-Label, Phase II Study".CLINICAL CANCER RESEARCH 28(2022).