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

文献类型：期刊论文

作者Li, Ning22; Zhang, Youzhong23; Wang, Jing24; Zhu, Jianqing25; Wang, Li26; Wu, Xiaohua27; Yao, Desheng33; Wu, Qiang28; Liu, Jihong29; Tang, Junying30
刊名JOURNAL OF CLINICAL ONCOLOGY
出版日期2022-08-01
卷号40
ISSN号0732-183X
DOI10.1200/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.
WOS关键词CANCER ; PROGRESSION ; INHIBITOR ; SURVIVAL
资助项目Jiangsu Hengrui Pharmaceuticals Co, Ltd.
WOS研究方向Oncology
语种英语
WOS记录号WOS:000855692200008
出版者LIPPINCOTT WILLIAMS & WILKINS
资助机构Jiangsu Hengrui Pharmaceuticals Co, Ltd.
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.Chongqing Univ Canc Hosp, Chongqing, Peoples R China
2.Harbin Med Univ Canc Hosp, Harbin, Peoples R China
3.Shandong First Med Univ & Shandong Acad Med Sci, Shandong Canc Hosp & Inst, Jinan, Peoples R China
4.Shanghai Gen Hosp, Shanghai, Peoples R China
5.Beijing Canc Hosp, Beijing, Peoples R China
6.Jiangxi Canc Hosp, Nanchang, Jiangxi, Peoples R China
7.Tianjin Cent Hosp Gynecol Obstet, Tianjin, Peoples R China
8.Liaoning Canc Hosp & Inst, Shenyang, Peoples R China
9.Shanxi Med Univ, Hosp 2, Taiyuan, Peoples R China
10.Hubei Canc Hosp, Wuhan, 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).

入库方式： OAI收割

来源：合肥物质科学研究院

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