Evidence map›Paper›PMID 27359058›Full record

Trial reportOncotarget2016

Fulvestrant 500 mg vs 250 mg in postmenopausal women with estrogen receptor-positive advanced breast cancer: a randomized, double-blind registrational trial in China.

Qingyuan Zhang, Zhimin Shao, Kunwei Shen, Li Li, Jifeng Feng, Zhongsheng Tong, Kangsheng Gu, Xiaojia Wang, Binghe Xu, Guofang Sun and 3 more

Abstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Oncotarget, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Article
  6. Observational
  7. Article
  8. Article
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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

13 authors.

Qingyuan ZhangHarbin Medical University Cancer Hospital, Harbin, Heilongjiang, China.
Zhimin ShaoFudan University Shanghai Cancer Center, Shanghai, China.
Kunwei ShenShanghai Ruijin Hospital, Shanghai, China.
Li LiThe First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning, China.
Jifeng FengJiangsu Cancer Hospital, Nanjing, Jiangsu, China.
Zhongsheng TongTianjin Cancer Hospital, Tianjin, China.
Kangsheng GuThe First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China.
Xiaojia WangZhejiang Cancer Hospital, Hangzhou, Zhejiang, China.
Binghe XuCancer Hospital and Institute, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Guofang SunAstraZeneca, Shanghai, China.
Huifang ChenAstraZeneca, Shanghai, China.
Yuri RukazenkovAstraZeneca, Macclesfield, UK.
Zefei JiangHospital of Chinese People's Liberation Army, Beijing, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The international CONFIRM study showed that fulvestrant 500 mg improved progression-free survival (PFS) vs fulvestrant 250 mg in postmenopausal women with estrogen receptor (ER)-positive locally advanced/metastatic breast cancer (LA/MBC). In this randomized, double-blind study, postmenopausal Chinese women with ER-positive LA/MBC and progression after endocrine therapy received fulvestrant 500 mg (days 0, 14, 28, and every 28 days thereafter) or fulvestrant 250 mg (every 28 days). Consistency with the international study was assumed if the hazard ratio (HR) for comparison of PFS (primary endpoint) was < 1 (stratified log-rank test). The study was not powered to assess between-group differences.In total, 221 patients were randomized (fulvestrant 500 mg: n = 111; fulvestrant 250 mg: n = 110). Baseline characteristics were balanced. Median PFS was 8.0 months with fulvestrant 500 mg vs 4.0 months with 250 mg (HR = 0.75; 95% confidence interval [CI] 0.54-1.03; P = 0.078). PFS (HR; 95% CI) favored fulvestrant 500 mg in post-antiestrogen (0.86; 0.54-1.37) and post-aromatase inhibitor (0.65; 0.42-1.03) settings. No new safety considerations were observed. These results are consistent with the international CONFIRM study, supporting the superior clinical benefit of fulvestrant 500 mg in women with ER-positive LA/MBC experiencing progression following prior endocrine therapy.

Indexed as

Drug Administration ScheduleAdultAgedAged, 80 and overAntineoplastic Agents, HormonalAromatase InhibitorsBreast NeoplasmsChinaDisease-Free SurvivalDouble-Blind MethodEstradiolEstrogen AntagonistsEstrogen Receptor alphaEstrogen Receptor ModulatorsFemaleFulvestrantAntineoplastic Agents, HormonalAromatase InhibitorsESR1 protein, humanEstradiolEstrogen AntagonistsEstrogen Receptor alphaEstrogen Receptor ModulatorsFulvestrantadvanced breast cancerendocrine therapyfulvestranthormone receptor-positive breast cancer

Identifiers

PMID27359058
PMCPMC5302990

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

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.