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Niraparib maintenance therapy using an individualised starting dose in patients with platinum-sensitive recurrent ovarian cancer (NORA): final overall survival analysis of a phase 3 randomised, placebo-controlled trial

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收录情况： ◇ SCIE

作者：
Wu Xiaohua[1] ; Zhu Jianqing[2] ; Yin Rutie[3] ; Yang Jiaxin[4] ; Liu Jihong[5] ; Wang Jing[6] ; Wu Lingying[7] ; Liu Ziling[8] ; Gao Yunong[9] ; Wang Danbo[10] ; Lou Ge[11] ; Yang Hongying[12] ; Zhou Qi[13] ; Kong Beihua[14] ; Huang Yi[15] ; Chen Lipai[16] ; Li Guiling[17] ; An Ruifang[18] ; Wang Ke[19] ; Zhang Yu[20] ; Yan Xiaojian[21] ; Lu Xin[22] ; Lu Weiguo[23] ; Hao Min[24] ; Wang Li[25] ; Cui Heng[26] ; Chen Qionghua[27] ; Abulizi Guzhalinuer[28] ; Huang Xianghua[29] ; Tian Xiaofei[30] ; Wen Hao[1] ; Huang Zhao[31] ; Dong Juan[31] ; Zhang Charlie[31] ; Hou Jianmei[31] ; Mirza Mansoor R[32] ;
机构： [1]Fudan University Shanghai Cancer Center, Shanghai, China. [2]Zhejiang Cancer Hospital, Hangzhou, China. [3]Department of Obstetrics and Gynecology, Key Laboratory of Birth Defects and Related Diseases of Women and Children, Ministry of Education, West China Second University Hospital, Sichuan University, Chengdu, China. [4]Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. [5]Sun Yat-sen University Cancer Center, Guangzhou, China. [6]Hunan Cancer Hospital, The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China. [7]National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. [8]The First Hospital of Jilin University, Changchun, China. [9]Peking University Cancer Hospital &amp [10] Institute, Beijing, China. [10]Liaoning Cancer Hospital &amp [12] Institute, Shenyang, China. [11]Harbin Medical University Cancer Hospital, Harbin, China. [12]The Third Affiliated Hospital of Kunming Medical University (Yunnan Cancer Hospital), Kunming, China. [13]Chongqing University Cancer Hospital, Chongqing, China. [14]Qilu Hospital of Shandong University, Jinan, China. [15]Hubei Cancer Hospital, Wuhan, China. [16]Affiliated Cancer Hospital of Guangzhou Medical University, Guangzhou, China. [17]Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. [18]The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China. [19]Tianjin Medical University Cancer Institute and Hospital, Tianjin, China. [20]Xiangya Hospital, Central South University, Changsha, China. [21]The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China. [22]Obstetrics &amp [25] Gynecology Hospital of Fudan University, Shanghai, China. [23]Women's Hospital, School of Medicine, Zhejiang University, Hangzhou, China. [24]The Second Hospital of Shanxi Medical University, Taiyuan, China. [25]Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China. [26]Peking University People's Hospital, Beijing, China. [27]The First Affiliated Hospital of Xiamen University, Xiamen, China. [28]The Affiliated Cancer Hospital of Xinjiang Medical University, Urumqi, China. [29]The Second Hospital of Hebei Medical University, Shijiazhuang, China. [30]Shaanxi Provincial Cancer Hospital, Xi'an, China. [31]Zai Lab (Shanghai) Co., Ltd, Shanghai, China. [32]Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
出处：
DOI： 10.1016/j.eclinm.2024.102629
ISSN：

关键词： PARP inhibitor Recurrent ovarian cancer Maintenance therapy Overall survival

摘要：
Niraparib significantly prolonged progression-free survival versus placebo in patients with platinum-sensitive, recurrent ovarian cancer (PSROC), regardless of germline BRCA mutation (gBRCAm) status, in NORA. This analysis reports final data on overall survival (OS).This randomised, double-blind, placebo-controlled, phase 3 trial enrolled patients across 30 centres in China between 26 September 2017 and 2 February 2019 (clinicaltrials.gov, NCT03705156). Eligible patients had histologically confirmed, recurrent, (predominantly) high-grade serous epithelial ovarian cancer, fallopian tube carcinoma, or primary peritoneal carcinoma (no histological restrictions for those with gBRCAm) and had received ≥2 prior lines of platinum-based chemotherapy. Patients were randomised (2:1) to receive niraparib or placebo, with stratification by gBRCAm status, time to recurrence following penultimate platinum-based chemotherapy, and response to last platinum-based chemotherapy. Following a protocol amendment, the starting dose was individualised: 200 mg/day for patients with bodyweight <77 kg and/or platelet count <150 × 103/μL at baseline and 300 mg/day otherwise. OS was a secondary endpoint.Totally, 265 patients were randomised to receive niraparib (n = 177) or placebo (n = 88), and 249 (94.0%) received an individualised starting dose. As of 14 August 2023, median follow-up for OS was 57.9 months (IQR, 54.8-61.6). Median OS (95% CI) with niraparib versus placebo was 51.5 (41.4-58.9) versus 47.6 (33.3-not evaluable [NE]) months, with hazard ratio [HR] of 0.86 (95% CI, 0.60-1.23), in the overall population; 56.0 (36.1-NE) versus 47.6 (31.6-NE) months, with HR of 0.86 (95% CI, 0.46-1.58), in patients with gBRCAm; and 46.5 (41.0-NE) versus 46.9 (31.8-NE) months, with HR of 0.87 (95% CI, 0.56-1.35), in those without. No new safety signals were identified, and myelodysplastic syndromes/acute myeloid leukaemia occurred in three (1.7%) niraparib-treated patients.Niraparib maintenance therapy with an individualised starting dose demonstrated a favourable OS trend versus placebo in PSROC patients, regardless of gBRCAm status.Zai Lab (Shanghai) Co., Ltd; National Major Scientific and Technological Special Project for "Significant New Drugs Development" in 2018, China [grant number 2018ZX09736019].© 2024 The Authors.

基金：
National Major Scientific and Technological Special Project for “Significant New Drugs Development” in 2018, China [grant number 2018ZX09736019]
语种：
外文
WOS：
PubmedID：
中科院(CAS)分区：
出版当年[2023]版：
大类 | 1 区 医学
小类 | 1 区 医学：内科
最新[2023]版：
大类 | 1 区 医学
小类 | 1 区 医学：内科
JCR分区：
出版当年[2023]版：
Q1 MEDICINE, GENERAL & INTERNAL
最新[2023]版：
Q1 MEDICINE, GENERAL & INTERNAL

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

第一作者：
第一作者机构： [1]Fudan University Shanghai Cancer Center, Shanghai, China.
通讯作者：
推荐引用方式(GB/T 7714)：
Wu Xiaohua,Zhu Jianqing,Yin Rutie,et al.Niraparib maintenance therapy using an individualised starting dose in patients with platinum-sensitive recurrent ovarian cancer (NORA): final overall survival analysis of a phase 3 randomised, placebo-controlled trial[J].ECLINICALMEDICINE.2024,72:102629.doi:10.1016/j.eclinm.2024.102629.
APA：
Wu Xiaohua,Zhu Jianqing,Yin Rutie,Yang Jiaxin,Liu Jihong...&Mirza Mansoor R.(2024).Niraparib maintenance therapy using an individualised starting dose in patients with platinum-sensitive recurrent ovarian cancer (NORA): final overall survival analysis of a phase 3 randomised, placebo-controlled trial.ECLINICALMEDICINE,72,
MLA：
Wu Xiaohua,et al."Niraparib maintenance therapy using an individualised starting dose in patients with platinum-sensitive recurrent ovarian cancer (NORA): final overall survival analysis of a phase 3 randomised, placebo-controlled trial".ECLINICALMEDICINE 72.(2024):102629

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