Fuzuloparib Maintenance Therapy in Patients With Platinum-Sensitive, Recurrent Ovarian Carcinoma (FZOCUS-2): A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Trial

doi:10.1200/JCO.21.01511

	Fuzuloparib Maintenance Therapy in Patients With Platinum-Sensitive, Recurrent Ovarian Carcinoma (FZOCUS-2): A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Trial
	Li, Ning 15; Zhang, Youzhong 2; Wang, Jing 3; Zhu, Jianqing 4; Wang, Li 5; Wu, Xiaohua 6; Yao, Desheng 7; Wu, Qiang 8; Liu, Jihong 9; Tang, Junying 10
刊名	JOURNAL OF CLINICAL ONCOLOGY
	2022-08-01
卷号	40
ISSN号	0732-183X
DOI	10.1200/JCO.21.01511
通讯作者	Wu, Lingying(wulingying@csco.org.cn)
英文摘要	PURPOSE This phase III trial aimed to explore the efficacy and safety of fuzuloparib (formerly fluzoparib) versus placebo as a maintenance treatment after response to second- or later-line platinum-based chemotherapy in patients with high-grade, platinum-sensitive, recurrent ovarian cancer. PATIENTS AND METHODS Patients with platinum-sensitive, recurrent ovarian cancer previously treated with at least two platinum-based regimens were assigned (2:1) to receive fuzuloparib (150 mg, twice daily) or matching placebo for 28-day cycles. The primary end points were progression-free survival (PFS) assessed by blinded independent review committee (BIRC) in the overall population and PFS by BIRC in the subpopulation with germline BRCA 1/2 mutation. RESULTS Between April 30, 2019, and January 10, 2020, 252 patients were randomly assigned to the fuzuloparib (n = 167) or placebo (n = 85). As of July 1, 2020, the median PFS per BIRC assessment in the overall population was significantly improved with fuzuloparib treatment (hazard ratio [HR], 0.25; 95% CI, 0.17 to 0.36; one-sided P < .0001) compared with that with placebo. The HR derived from a prespecified subgroup analysis showed a consistent trend of benefit in patients with germline BRCA 1/2 mutations (HR, 0.14; 95% CI, 0.07 to 0.28) or in those without mutations (HR, 0.46; 95% CI, 0.29 to 0.74). The most common grade >= 3 treatment-emergent adverse events reported in the fuzuloparib group were anemia (25.1%), decreased platelet count (16.8%), and decreased neutrophil count (12.6%). Only one patient (0.6%) discontinued fuzuloparib because of treatment-related toxicity (concurrent decreased white blood cell count and neutrophil count). CONCLUSION Fuzuloparib as maintenance therapy achieved a statistically significant and clinically meaningful improvement in PFS for patients with platinum-sensitive, recurrent ovarian cancer versus placebo, regardless of germline BRCA 1/2 mutation, and showed a manageable safety profile.
资助项目	Jiangsu Hengrui Pharmaceuticals Co, Ltd.
WOS关键词	CANCER ; PROGRESSION ; INHIBITOR ; SURVIVAL
WOS研究方向	Oncology
语种	英语
出版者	LIPPINCOTT WILLIAMS & WILKINS
WOS记录号	WOS:000855692200008
资助机构	Jiangsu Hengrui Pharmaceuticals Co, Ltd.
内容类型	期刊论文
源URL	[http://ir.hfcas.ac.cn:8080/handle/334002/128974]
专题	中国科学院合肥物质科学研究院
通讯作者	Wu, Lingying
作者单位	1.Sichuan Canc Hosp, Chengdu, Peoples R China 2.Shandong Univ, Qilu Hosp, Jinan, Peoples R China 3.Cent South Univ, Xiangya Sch Med, Affiliated Canc Hosp, Hunan Canc Hosp, Changsha, Peoples R China 4.Univ Chinese Acad Sci, Zhejiang Canc Hosp, Canc Hosp, Hangzhou, Peoples R China 5.Zhengzhou Univ, Henan Canc Hosp, Affiliated Canc Hosp, Zhengzhou, Peoples R China 6.Fudan Univ, Shanghai Canc Ctr, Shanghai, Peoples R China 7.Guangxi Med Univ Canc Hosp, Nanning, Peoples R China 8.Jiangsu Canc Hosp, Nanjing, Peoples R China 9.Sun Yat Sen Univ Canc Ctr, Guangzhou, Peoples R China 10.Chongqing Med Univ, Affiliated Hosp 1, Chongqing, Peoples R China
推荐引用方式 GB/T 7714	Li, Ning,Zhang, Youzhong,Wang, Jing,et al. Fuzuloparib Maintenance Therapy in Patients With Platinum-Sensitive, Recurrent Ovarian Carcinoma (FZOCUS-2): A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Trial[J]. JOURNAL OF CLINICAL ONCOLOGY,2022,40.
APA	Li, Ning.,Zhang, Youzhong.,Wang, Jing.,Zhu, Jianqing.,Wang, Li.,...&Wu, Lingying.(2022).Fuzuloparib Maintenance Therapy in Patients With Platinum-Sensitive, Recurrent Ovarian Carcinoma (FZOCUS-2): A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Trial.JOURNAL OF CLINICAL ONCOLOGY,40.
MLA	Li, Ning,et al."Fuzuloparib Maintenance Therapy in Patients With Platinum-Sensitive, Recurrent Ovarian Carcinoma (FZOCUS-2): A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Trial".JOURNAL OF CLINICAL ONCOLOGY 40(2022).