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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.

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机构： [1]National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College Cancer Hospital Chinese Academy of Medical Sciences, Beijing, China [2]Qilu Hospital of Shandong University, Jinan, China [3]The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University (Hunan Cancer Hospital), Changsha, China [4]Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Hangzhou, China [5]Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China [6]Fudan University Shanghai Cancer Center, Shanghai, China [7]Guangxi Medical University Cancer Hospital, Nanning, China [8]Jiangsu Cancer Hospital, Nanjing, China [9]Sun Yat-Sen University Cancer Center, Guangzhou, China [10]The First Affiliated Hospital of Chongqing Medical University, Chongqing, China [11]West China Second University Hospital, Sichuan University, Chengdu, China/Key Laboratory of Obstetrics & Gynecologic and Pediatric Diseases and Birth Defects of Ministry of Education, West China Second University Hospital, Sichuan University, Chengdu, China [12]Harbin Medical University Cancer Hospital, Harbin, China [13]The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China [14]Sichuan Cancer Hospital, Chengdu, China [15]Anhui Provincial Cancer Hospital, Hefei, China [16]Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, China [17]Shanghai General Hospital, Shanghai, China [18]Beijing Cancer Hospital, Beijing, China [19]Jiangxi Cancer Hospital, Nanchang, China [20]Tianjin Central Hospital of Gynecology Obstetrics, Tianjin, China [21]Liaoning Cancer Hospital & Institute, Shenyang, China [22]The Second Hospital of Shanxi Medical University, Taiyuan, China [23]Hubei Cancer Hospital, Wuhan, China [24]Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China [25]Chongqing University Cancer Hospital, Chongqing, China [26]Shanghai First Maternity and Infant Hospital, Shanghai, China [27]The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China [28]Woman's Hospital School of Medicine Zhejiang University, Hangzhou, China [29]Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, Nanjing, China [30]Obstetrics & Gynecology Hospital of Fudan University, Shanghai, China [31]Yunnan Cancer Hospital, Yunnan, China [32]Peking University People's Hospital, Beijing, China [33]PLA General Hospital, Beijing, China [34]The First Bethune Hospital of Jilin University, Changchun, China [35]Jiangsu Hengrui Pharmaceuticals Co, Ltd, Shanghai, China

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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 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.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).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.

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大类 | 1 区

医学

小类 | 1 区肿瘤学

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大类 | 1 区

医学

小类 | 1 区肿瘤学

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出版当年[2022]版：

Q1 ONCOLOGY

最新[2023]版：

Q1 ONCOLOGY

影响因子： 42.1 最新[2023版] 37.4 最新五年平均 45.4 出版当年[2022版] 37.7 出版当年五年平均 50.739 出版前一年[2021版] 42.1 出版后一年[2023版]

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第一作者机构： [1]National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College Cancer Hospital Chinese Academy of Medical Sciences, Beijing, China

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