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Niraparib maintenance therapy in patients with platinum-sensitive recurrent ovarian cancer using an individualized starting dose (NORA): a randomized, double-blind, placebo-controlled phase 3 trial.

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作者：
Wu X H[1,*1] * ; Zhu J Q[2] * ; Yin R T[3] * ; Yang J X[4] ; Liu J H[5] ; Wang J[6] ; Wu L Y[7] ; Liu Z L[8] ; Gao Y N[9] ; Wang D B[10] ; Lou G[11] ; Yang H Y[12] ; Zhou Q[13] ; Kong B H[14] ; Huang Y[15] ; Chen L P[16] ; Li G L[17] ; An R F[18] ; Wang K[19] ; Zhang Y[20] ; Yan X J[21] ; Lu X[22] ; Lu W G[23] ; Hao M[24] ; Wang L[25] ; Cui H[26] ; Chen Q H[27] ; Abulizi G[28] ; Huang X H[29] ; Tian X F[30] ; Wen H[1] ; Zhang C[31] ; Hou J M[31] ; Mirza M R[32] ;
机构： [1]Department of Gynecologic Oncology, Fudan University Shanghai Cancer Center,Shanghai, China [2]Department of Gynecologic Oncology, Cancer hospital of the University of ChineseAcademy of Sciences (Zhejiang Cancer Hospital), Zhejiang, China [3]Department of Obstetrics and Gynecology, West China Second University Hospital,Key Laboratory of Birth Defects and Related Diseases of Women and Children,Ministry of Education, Sichuan University, Chengdu, China [4]Department of Gynecologic Oncology, Peking Union Medical College Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing,China [5]Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center,Guangzhou, China [6]Department of Gynecologic Oncology, Hunan Cancer Hospital, the Affiliated CancerHospital of Xiangya School of Medicine, Central South University, Changsha, China [7]Department of Gynecologic Oncology, National Cancer Center/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing,China [8]Department of Oncology, The First Hospital of Jilin University, Changchun, China [9]Department of Gynecology, Peking University Cancer Hospital & Institute, Beijing,China [10]Department of Gynecology, Cancer Hospital of China Medical University, LiaoningCancer Hospital and Institute, Shenyang, China [11]Department of Gynecology, Harbin Medical University Cancer Hospital, Harbin,China [12]Department of Gynecologic Oncology, The Third Affiliated Hospital of KunmingMedical University/Yunnan Cancer Hospital, Yunnan, China [13]Gynecological Oncology Center, Chongqing University Cancer Hospital, Chongqing,China [14]Department of Obstetrics and Gynecology, Qilu Hospital of Shandong University,Ji’nan, China [15]Department of Gynecologic Oncology, Hubei Cancer Hospital, Wuhan, China [16]Department of Gynecological Oncology, Affiliated Cancer Hospital of GuangzhouMedical University, Guangzhou, China [17]Cancer Center, Union Hospital, Tongji Medical College, Huazhong University ofScience and Technology, Wuhan, China [18]Department of Obstetrics and Gynecology, The First Affiliated Hospital of Xi'anJiaotong University, Xi’an, China [19]Department of Gynecologic Oncology, Tianjin Medical University Cancer Instituteand Hospital, Tianjin, China [20]Department of Obstetrics and Gynecology, Xiangya Hospital, Central SouthUniversity, Changsha, China [21]Department of Gynecology, The First Affiliated Hospital of Wenzhou MedicalUniversity, Wenzhou, China [22]Department of Gynecology Oncology, Obstetrics & Gynecology Hospital of FudanUniversity [23]Department of Gynecology and Obstetrics, Women’s Hospital, School of Medicine,Zhejiang University, Hangzhou, China [24]Department of Obstetrics and Gynecology, The Second Hospital of Shanxi MedicalUniversity, Taiyuan, China [25]Department of Gynecological Oncology, Affiliated Cancer Hospital of ZhengzhouUniversity, Zhengzhou, China [26]Department of Obstetrics and Gynecology, Center of Gynecologic Oncology, PekingUniversity People's Hospital, Beijing, China [27]Department of Gynecology, The First Affiliated Hospital of Xiamen University,Xiamen, China [28]Department of Gynecology, The Affiliated Cancer Hospital of Xinjiang MedicalUniversity, Ürümqi, China [29]Department of Obstetrics and Gynecology, The Second Hospital of Hebei MedicalUniversity, Shijiazhuang, China [30]Department of Gynecology Oncology, Shanxi Provincial Tumor Hospital, Xi’an,China [31]R&D department, Zai Lab (Shanghai) Co., Ltd, Shanghai, China [32]Department of Oncology, Rigshospitalet, Copenhagen University Hospital, Denmark
出处：
DOI： 10.1016/j.annonc.2020.12.018
ISSN：

摘要：
This study evaluated maintenance treatment with niraparib, a potent inhibitor of poly(ADP-ribose) polymerase 1/2, in patients with platinum-sensitive recurrent ovarian cancer. In this phase 3, double-blind, placebo-controlled study conducted at 30 centers in China, adults with platinum-sensitive recurrent ovarian cancer who had responded to their most recent platinum-containing chemotherapy were randomized 2:1 to oral niraparib (300 mg/day) or matched placebo until disease progression or unacceptable toxicity (NCT03705156). Following a protocol amendment, patients with bodyweight <77 kg or platelet count <150×103/μL received 200 mg/day, and all other patients 300 mg/day, as an individualized starting dose (ISD). Randomization was by interactive web response system and stratified by BRCA mutation, time-to-recurrence following penultimate chemotherapy and response to most recent chemotherapy. The primary endpoint was progression-free survival (PFS) assessed by blinded independent central review. Between September 26, 2017 and February 2, 2019, 265 patients were randomized to niraparib (n=177) or placebo (n=88); 249 patients received an ISD (300 mg, n=14; 200 mg, n=235) per protocol. In the ITT population, median PFS was significantly longer for patients receiving niraparib versus placebo: 18.3 (95% CI, 10.9-not evaluable) versus 5.4 (95% CI, 3.7-5.7) months (HR=0.32; 95% CI, 0.23-0.45; p <0.0001), and a similar PFS benefit was observed in patients receiving an ISD, regardless of BRCA mutation status. Grade ≥3 treatment-emergent adverse events occurred in 50.8% and 19.3% of patients who received niraparib and placebo, respectively; the most common were neutrophil count decreased (20.3 vs. 8.0%), and anemia (14.7 vs. 2.3%). Niraparib maintenance treatment reduced the risk of disease progression or death by 68% and prolonged PFS compared to placebo in patients with platinum-sensitive recurrent ovarian cancer. Individualized niraparib dosing is effective and safe and should be considered standard practice in this setting. Copyright © 2021 The Author(s). Published by Elsevier Ltd.. All rights reserved.

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出版当年[2021]版：
大类 | 1 区 医学
小类 | 1 区 肿瘤学
最新[2023]版：
大类 | 1 区 医学
小类 | 1 区 肿瘤学
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出版当年[2020]版：
Q1 ONCOLOGY
最新[2023]版：
Q1 ONCOLOGY

影响因子： 最新[2023版] 最新五年平均 出版当年[2020版] 出版当年五年平均 出版前一年[2019版] 出版后一年[2021版]

第一作者：
第一作者机构： [1]Department of Gynecologic Oncology, Fudan University Shanghai Cancer Center,Shanghai, China [*1]Fudan University Shanghai Cancer Center, No.255, Dong' An Road, Shanghai 200032,China
共同第一作者：
通讯作者：
通讯机构： [1]Department of Gynecologic Oncology, Fudan University Shanghai Cancer Center,Shanghai, China [*1]Fudan University Shanghai Cancer Center, No.255, Dong' An Road, Shanghai 200032,China
推荐引用方式(GB/T 7714)：
Wu X H,Zhu J Q,Yin R T,et al.Niraparib maintenance therapy in patients with platinum-sensitive recurrent ovarian cancer using an individualized starting dose (NORA): a randomized, double-blind, placebo-controlled phase 3 trial.[J].ANNALS OF ONCOLOGY.2021,32(4):512-521.doi:10.1016/j.annonc.2020.12.018.
APA：
Wu X H,Zhu J Q,Yin R T,Yang J X,Liu J H...&Mirza M R.(2021).Niraparib maintenance therapy in patients with platinum-sensitive recurrent ovarian cancer using an individualized starting dose (NORA): a randomized, double-blind, placebo-controlled phase 3 trial..ANNALS OF ONCOLOGY,32,(4)
MLA：
Wu X H,et al."Niraparib maintenance therapy in patients with platinum-sensitive recurrent ovarian cancer using an individualized starting dose (NORA): a randomized, double-blind, placebo-controlled phase 3 trial.".ANNALS OF ONCOLOGY 32..4(2021):512-521

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