Evidence map›Paper›PMID 21959870›Full record

Trial reportBritish journal of cancer2011

Randomised, phase III trial of epoetin-β to treat chemotherapy-induced anaemia according to the EU regulation.

Y Fujisaka, T Sugiyama, H Saito, S Nagase, S Kudoh, M Endo, H Sakai, Y Ohashi, N Saijo

Open access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in British journal of cancer, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 5 pooled it
3.1field-weighted citation impact, top 8% of its field
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

17 citing papers in PubMed, 5 syntheses or guidelines pooled it, 35 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Venous thromboembolism risk and erythropoiesis-stimulating agents for the treatment of cancer-associated anemia: a meta-analysis.Tumour biology : the journal of the International Society for Oncodevelopmental Biology and Medicine · 2014
    Pooled it
  4. Pooled it
  5. Erythropoietin or darbepoetin for patients with cancer.The Cochrane database of systematic reviews · 2012
    Pooled it
  6. Trial
  7. Trial
  8. Review
  9. Article
  10. Article
  11. Review
  12. Review
  13. Article
  14. Review
  15. Erythropoiesis-stimulating agents in the management of cancer patients with anemia: a meta-analysis.Chinese journal of cancer research = Chung-kuo yen cheng yen chiu · 2014
    Article
  16. Review
  17. Questionnaire-based survey on chemotherapy-induced anemia.International journal of clinical oncology · 2014
    Article
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

9 authors at 9 institutions in 1 country.

Y FujisakaRespiratory Medicine, Osaka Medical College Hospital, Osaka, Japan. fujisaka_y@dotd.med.kindai.ac.jp
T Sugiyama
H Saito
S Nagase
S Kudoh
M Endo
H Sakai
Y Ohashi
N Saijo
Aichi Cancer Center · JPIwate Medical University · JPKindai University · JPOsaka City University Hospital · JPOsaka Medical and Pharmaceutical University · JPSaitama Cancer Center · JPShizuoka Cancer Center · JPThe University of Tokyo · JPTokyo Medical University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundErythropoietin-stimulating agents (ESAs) effectively decrease the transfusion requirements of patients with chemotherapy-induced anaemia (CIA). Recent studies indicate that ESAs increase mortality and accelerate tumour progression. The studies also identify a 1.6-fold increased risk of venous thromboembolism. The ESA labelling was thus revised in Europe and the United States in 2008. This is the first randomised, phase III trial evaluating the efficacy and safety of epoetin-β (EPO), an ESA, dosed in accordance with the revised labelling, which specifies that ESAs should be administered to CIA patients with a haemoglobin level of ≤ 10 g dl⁻¹ and that a sustained haemoglobin level of > 12 g dl⁻¹ should be avoided.

methodsA total of 186 CIA patients (8.0 g dl⁻¹ ≤ haemoglobin ≤ 10.0 g dl⁻¹) with lung or gynaecological cancer were randomised to receive EPO 36,000 IU or placebo weekly for 12 weeks.

resultsThe proportion of patients receiving transfusions or with haemoglobin < 8.0 g dl⁻¹ between week 5 and the end of the treatment period as the primary end point was significantly lower in the EPO group (n=89) than in the placebo group (n=92; 10.0% vs 56.4%, P < 0.001). The proportion receiving transfusions was significantly lower in the EPO group (4.5% vs 19.6%, P=0.002). Changes in quality of life were not different. No significant differences in adverse events - for example, the incidence of thromboembolic events was 1.1% for each group - or the 1-year overall survival were observed between groups.

conclusionWeekly EPO administered according to the revised labelling approved by the European Medicines Agency is effective and well tolerated for CIA treatment. Further investigations are needed on the effect of ESAs on mortality.

Indexed as

AdultAgedAnemiaAntineoplastic Combined Chemotherapy ProtocolsBlood TransfusionErythropoietinFemaleGenital Neoplasms, FemaleHemoglobinsHumansLung NeoplasmsMaleMiddle AgedPlacebosQuality of LifeRecombinant Proteinsepoetin betaErythropoietinHemoglobinsPlacebosRecombinant Proteins

Identifiers

PMID21959870
PMCPMC3241560
OpenAlexW1997666518

What OpenQuestion holds

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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.