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

HFCAS OpenIR

	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 1; Zhu, Jianqing 2; Wang, Jing 3; Lin, Zhongqiu 4; Yin, Rutie 5; Sun, Wei 6; Zhou, Qi 7,8,9; Zhang, Songling 10; Wang, Danbo 11; Shi, Hong 12; Gao, Yunong 13; Huang, Yi 14; Li, Guiling 15; Wang, Xiuli 16; Cheng, Ying 17; Lou, Ge 18; Gao, Qinglei 19; Wang, Li 20; Du, Xiuping 21; Pan, Mei 22; Mu, Xiyan 23; Li, Li 24; Li, Miao 25; Mu, Song 26; Kong, Beihua 27
	2022-02-15
发表期刊	CLINICAL CANCER RESEARCH
ISSN	1078-0432
通讯作者	Wu, Xiaohua(wu.xh@fudan.edu.cn)
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.
DOI	10.1158/1078-0432.CCR-21-1186
关键词[WOS]	SELECTIVE PARP INHIBITOR ; ANTITUMOR-ACTIVITY ; BRCA2 MUTATION ; OLAPARIB ; SAFETY ; CARCINOMA ; RUCAPARIB ; POTENT
收录类别	SCI
语种	英语
资助项目	BeiGene, Ltd.
项目资助者	BeiGene, Ltd.
WOS研究方向	Oncology
WOS类目	Oncology
WOS记录号	WOS:000756668200001
出版者	AMER ASSOC CANCER RESEARCH
引用统计	被引频次：10[WOS] [WOS记录] [WOS相关记录]
文献类型	期刊论文
条目标识符	http://ir.hfcas.ac.cn:8080/handle/334002/127910
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.Fudan Univ, Dept Gynecol Oncol, Shanghai Canc Ctr, Shanghai 200032, Peoples R China 2.Univ Chinese Acad Sci, Dept Gynecol Oncol, Zhejiang Canc Hosp, Canc Hosp, Hangzhou, Peoples R China 3.Cent South Univ, Hunan Canc Hosp, Dept Gynecol & Oncol, Affiliated Canc Hosp,Xiangya Sch Med, Changsha, Peoples R China 4.Sun Yat Sen Univ, Sun Yat Sen Mem Hosp, Dept Gynecol Oncol, Guangzhou, Peoples R China 5.Sichuan Univ, Key Lab Birth Defects & Related Dis Women & Child, West China Hosp 2, Dept Obstet & Gynecol,Minist Educ, Chengdu, Peoples R China 6.Anhui Prov Canc Hosp, Affiliated Hosp USTC 1, Dept Gynecol Oncol, Hefei, Peoples R China 7.Chongqing Univ, Dept Gynecol Oncol, Canc Hosp, Chongqing, Peoples R China 8.Chongqing Canc Inst, Chongqing, Peoples R China 9.Chongqing Canc Hosp, Chongqing, Peoples R China 10.First Hosp Jilin Univ, Dept Gynecol Oncol, Changchun, Peoples R China 11.China Med Univ, Liaoning Canc Hosp & Inst, Dept Gynecol, Canc Hosp, Shenyang, Liaoning, Peoples R China 12.Dalian Med Univ, Affiliated Hosp 1, Dept Obstet & Gynecol, Dalian, Peoples R China 13.Peking Univ, Beijing Canc Hosp, Beijing Inst Canc Res, Dept Gynecol Oncol,Sch Oncol, Beijing, Peoples R China 14.Huazhong Univ Sci & Technol, Hubei Canc Hosp, Tongji Med Coll, Dept Gynecol Oncol, Wuhan, Peoples R China 15.Huazhong Univ Sci & Technol, Union Hosp, Tongji Med Coll, Canc Ctr, Wuhan, Peoples R China 16.Second Hosp Jilin Univ, Dept Oncol & Hematol, Changchun, Peoples R China 17.Jilin Canc Hosp, Dept Med Oncol, Changchun, Peoples R China 18.Harbin Med Univ, Dept Gynecol, Canc Hosp, Harbin, Peoples R China 19.Huazhong Univ Sci & Technol, Med Coll, Dept Obstet & Gynecol, Wuhan, Hubei, Peoples R China 20.Zhengzhou Univ, Dept Gynecol Oncol, Affiliated Canc Hosp, Zhengzhou, Henan, Peoples R China 21.Xuzhou Med Univ, Dept Oncol, Affiliated Hosp, Xuzhou, Jiangsu, Peoples R China 22.Maternal & Child Hlth Hosp Jiangxi Prov, Dept Gynecol Oncol, Nanchang, Jiangxi, Peoples R China 23.BeiGene Ltd, Dept Clin Dev, Shanghai, Peoples R China 24.BeiGene Ltd, Dept Biostat, Beijing, Peoples R China 25.BeiGene Ltd, Dept Clin Dev, Beijing, Peoples R China 26.BeiGene USA Inc, Dept Clin Pharmacol, San Mateo, CA USA 27.Shandong Univ, Dept Obstet & Gynecol, Qilu Hosp, Jinan, 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).