获取途径

作者

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

作者单位

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

刊名

Journal of Clinical Oncology

年份

2022

卷号

Vol.40 No.22

页码

2436-2446

ISSN

0732-183X

摘要

PURPOSEThis phase III trial aimed to explore the efficacy and safety of fuzuloparib 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 METHODSPatients with platinum-sensitive, recurrent ovarian cancer previously treated with at least two platinum-based regimens were assigned to receive fuzuloparib or matching placebo for 28-day cycles. The primary en...更多

PURPOSEThis phase III trial aimed to explore the efficacy and safety of fuzuloparib 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 METHODSPatients with platinum-sensitive, recurrent ovarian cancer previously treated with at least two platinum-based regimens were assigned to receive fuzuloparib or matching placebo for 28-day cycles. The primary end points were progression-free survival assessed by blinded independent review committee in the overall population and PFS by BIRC in the subpopulation with germline BRCA 1/2 mutation.RESULTSBetween April 30, 2019, and January 10, 2020, 252 patients were randomly assigned to the fuzuloparib or placebo . As of July 1, 2020, the median PFS per BIRC assessment in the overall population was significantly improved with fuzuloparib treatment 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 or in those without mutations . The most common grade ≥ 3 treatment-emergent adverse events reported in the fuzuloparib group were anemia , decreased platelet count , and decreased neutrophil count . Only one patient discontinued fuzuloparib because of treatment-related toxicity .CONCLUSIONFuzuloparib 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. © American Society of Clinical Oncology.收起

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