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

作者全名："Li, Ning; Zhang, Youzhong; Wang, Jing; Zhu, Jianqing; Wang, Li; Wu, Xiaohua; Yao, Desheng; Wu, Qiang; Liu, Jihong; Tang, Junying; Yin, Rutie; Lou, Ge; An, Ruifang; Zhang, Guonan; Xia, Xiaoping; Li, Qingshui; Zhu, Yaping; Zheng, Hong; Yang, Xinfeng; Hu, Yuanjing; Zhang, Xin; Hao, Min; Huang, Yi; Lin, Zhongqiu; Wang, Dong; Guo, Xiaoqing; Yao, Shuzhong; Wan, Xiaoyun; Zhou, Huaijun; Yao, Liangqing; Yang, Xielan; Cui, Heng; Meng, Yuanguang; Zhang, Songling; Qu, Jing; Zhang, Ben; Zou, Jianjun; Wu, Lingying"

作者地址："[Li, Ning; Wu, Lingying] Chinese Acad Med Sci, Chinese Acad Med Sci & Peking Union Med Coll, Canc Hosp, Natl Canc Ctr,Natl Clin Res Ctr Canc, Beijing, Peoples R China; [Zhang, Youzhong] Shandong Univ, Qilu Hosp, Jinan, Peoples R China; [Wang, Jing] Cent South Univ, Xiangya Sch Med, Affiliated Canc Hosp, Hunan Canc Hosp, Changsha, Peoples R China; [Zhu, Jianqing] Univ Chinese Acad Sci, Zhejiang Canc Hosp, Canc Hosp, Hangzhou, Peoples R China; [Wang, Li] Zhengzhou Univ, Henan Canc Hosp, Affiliated Canc Hosp, Zhengzhou, Peoples R China; [Wu, Xiaohua] Fudan Univ, Shanghai Canc Ctr, Shanghai, Peoples R China; [Yao, Desheng] Guangxi Med Univ Canc Hosp, Nanning, Peoples R China; [Wu, Qiang] Jiangsu Canc Hosp, Nanjing, Peoples R China; [Liu, Jihong] Sun Yat Sen Univ Canc Ctr, Guangzhou, Peoples R China; [Tang, Junying] Chongqing Med Univ, Affiliated Hosp 1, Chongqing, Peoples R China; [Yin, Rutie] Sichuan Univ, West China Second Univ Hosp, Chengdu, Peoples R China; [Yin, Rutie] Sichuan Univ, West China Univ Hosp 2, Minist Educ, Key Lab Obstet & Gynecol & Pediat Dis & Birth Def, Chengdu, Peoples R China; [Lou, Ge] Harbin Med Univ Canc Hosp, Harbin, Peoples R China; [An, Ruifang] Xi An Jiao Tong Univ, Affiliated Hosp 1, Xian, Peoples R China; [Zhang, Guonan] Sichuan Canc Hosp, Chengdu, Peoples R China; [Xia, Xiaoping] Anhui Prov Canc Hosp, Hefei, Peoples R China; [Li, Qingshui] Shandong First Med Univ & Shandong Acad Med Sci, Shandong Canc Hosp & Inst, Jinan, Peoples R China; [Zhu, Yaping] Shanghai Gen Hosp, Shanghai, Peoples R China; [Zheng, Hong] Beijing Canc Hosp, Beijing, Peoples R China; [Yang, Xinfeng] Jiangxi Canc Hosp, Nanchang, Jiangxi, Peoples R China; [Hu, Yuanjing] Tianjin Cent Hosp Gynecol Obstet, Tianjin, Peoples R China; [Zhang, Xin] Liaoning Canc Hosp & Inst, Shenyang, Peoples R China; [Hao, Min] Shanxi Med Univ, Hosp 2, Taiyuan, Peoples R China; [Huang, Yi] Hubei Canc Hosp, Wuhan, Peoples R China; [Lin, Zhongqiu] Sun Yat Sen Univ, Sun Yat Sen Mem Hosp, Guangzhou, Peoples R China; [Wang, Dong] Chongqing Univ Canc Hosp, Chongqing, Peoples R China; [Guo, Xiaoqing] Shanghai First Matern & Infant Hosp, Shanghai, Peoples R China; [Yao, Shuzhong] Sun Yat Sen Univ, Affiliated Hosp 1, Guangzhou, Peoples R China; [Wan, Xiaoyun] Zhejiang Univ, Womans Hosp, Sch Med, Hangzhou, Peoples R China; [Zhou, Huaijun] Nanjing Univ Med Sch, Affiliated Hosp, Nanjing Drum Tower Hosp, Nanjing, Peoples R China; [Yao, Liangqing] Fudan Univ, Obstet & Gynecol Hosp, Shanghai, Peoples R China; [Yang, Xielan] Yunnan Canc Hosp, Kunming, Yunnan, Peoples R China; [Cui, Heng] Peking Univ Peoples Hosp, Beijing, Peoples R China; [Meng, Yuanguang] Peoples Liberat Army Gen Hosp, Beijing, Peoples R China; [Zhang, Songling] Jilin Univ, Bethune Hosp 1, Changchun, Peoples R China; [Qu, Jing; Zhang, Ben; Zou, Jianjun] Jiangsu Hengrui Pharmaceut Co Ltd, Shanghai, Peoples R China"

通信作者："Wu, LY (通讯作者)，Chinese Acad Med Sci, Canc Hosp, Chinese Acad Med Sci & Peking Union Med Coll, Dept Gynecol,Natl Canc Ctr,Natl Clin Res Ctr Canc, Beijing 100021, Peoples R China."

来源：JOURNAL OF CLINICAL ONCOLOGY

ESI学科分类：CLINICAL MEDICINE

WOS号：WOS:000855692200008

JCR分区：Q1

影响因子：45.3

年份：2022

卷号：40

期号：22

开始页：2436

结束页：+

文献类型：Article

关键词：　

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."

基金机构："Jiangsu Hengrui Pharmaceuticals Co, Ltd."

基金资助正文："Supported by Jiangsu Hengrui Pharmaceuticals Co, Ltd."