Evidence map›Paper›PMID 38745967›Full record

ArticleEClinicalMedicine2024

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.

Xiaohua Wu, Jianqing Zhu, Rutie Yin, Jiaxin Yang, Jihong Liu, Jing Wang, Lingying Wu, Ziling Liu, Yunong Gao, Danbo Wang and 26 more

Registry-linked trialAbstract read
In one paragraph

Article in EClinicalMedicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03705156 (A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Phase III Clinical Trial Evaluating the Efficacy and Safety of ZL-2306), which is not on this map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03705156 phase3unknown statusnot on this map

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Phase III Clinical Trial Evaluating the Efficacy and Safety of ZL-2306 (Niraparib) for Maintenance Treatment in Patients With Platinum-sensitive Relapsed Ovarian Cancer, Fallopian Tube Carcinoma or Primary Peritoneal Cancer (Collectively Referred to as Ovarian Cancer)

TypeinterventionalSponsorZai Lab (Shanghai) Co., Ltd.Ran2017 to 2024Enrolled265ConditionsPlatinum-sensitive Relapsed Ovarian CancerArmsZL-2306(nirapairb), Placebos
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  4. Clinical and molecular determinants of response to maintenance olaparib for primary and recurrent epithelial ovarian carcinoma.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

36 authors.

Xiaohua WuFudan University Shanghai Cancer Center, Shanghai, China.
Jianqing ZhuZhejiang Cancer Hospital, Hangzhou, China.
Rutie YinDepartment 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.
Jiaxin YangPeking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Jihong LiuSun Yat-sen University Cancer Center, Guangzhou, China.
Jing WangHunan Cancer Hospital, The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China.
Lingying WuNational Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Ziling LiuThe First Hospital of Jilin University, Changchun, China.
Yunong GaoPeking University Cancer Hospital & Institute, Beijing, China.
Danbo WangLiaoning Cancer Hospital & Institute, Shenyang, China.
Ge LouHarbin Medical University Cancer Hospital, Harbin, China.
Hongying YangThe Third Affiliated Hospital of Kunming Medical University (Yunnan Cancer Hospital), Kunming, China.
Qi ZhouChongqing University Cancer Hospital, Chongqing, China.
Beihua KongQilu Hospital of Shandong University, Jinan, China.
Yi HuangHubei Cancer Hospital, Wuhan, China.
Lipai ChenAffiliated Cancer Hospital of Guangzhou Medical University, Guangzhou, China.
Guiling LiCancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Ruifang AnThe First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.
Ke WangTianjin Medical University Cancer Institute and Hospital, Tianjin, China.
Yu ZhangXiangya Hospital, Central South University, Changsha, China.
Xiaojian YanThe First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China.
Xin LuObstetrics & Gynecology Hospital of Fudan University, Shanghai, China.
Weiguo LuWomen's Hospital, School of Medicine, Zhejiang University, Hangzhou, China.
Min HaoThe Second Hospital of Shanxi Medical University, Taiyuan, China.
Li WangAffiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.
Heng CuiPeking University People's Hospital, Beijing, China.
Qionghua ChenThe First Affiliated Hospital of Xiamen University, Xiamen, China.
Guzhalinuer AbuliziThe Affiliated Cancer Hospital of Xinjiang Medical University, Urumqi, China.
Xianghua HuangThe Second Hospital of Hebei Medical University, Shijiazhuang, China.
Xiaofei TianShaanxi Provincial Cancer Hospital, Xi'an, China.
Hao WenFudan University Shanghai Cancer Center, Shanghai, China.
Zhao HuangZai Lab (Shanghai) Co., Ltd, Shanghai, China.
Juan DongZai Lab (Shanghai) Co., Ltd, Shanghai, China.
Charlie ZhangZai Lab (Shanghai) Co., Ltd, Shanghai, China.
Jianmei HouZai Lab (Shanghai) Co., Ltd, Shanghai, China.
Mansoor R MirzaRigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Niraparib significantly prolonged progression-free survival versus placebo in patients with platinum-sensitive, recurrent ovarian cancer (PSROC), regardless of germline Methods: 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 g Findings: 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 g Interpretation: Niraparib maintenance therapy with an individualised starting dose demonstrated a favourable OS trend versus placebo in PSROC patients, regardless of g Funding: Zai Lab (Shanghai) Co., Ltd; National Major Scientific and Technological Special Project for "Significant New Drugs Development" in 2018, China [grant number 2018ZX09736019].

Indexed as

Maintenance therapyOverall survivalPARP inhibitorRecurrent ovarian cancer

Identifiers

PMID38745967
PMCPMC11090914

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.