Evidence map›Paper›PMID 28626220›Full record

Trial reportLeukemia2017

A phase 3 randomized placebo-controlled trial of darbepoetin alfa in patients with anemia and lower-risk myelodysplastic syndromes.

U Platzbecker, A Symeonidis, E N Oliva, J S Goede, M Delforge, J Mayer, B Slama, S Badre, E Gasal, B Mehta and 1 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Leukemia, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01362140 (A Multicenter, Randomised, Double-blind, Placebo-controlled Study of Darbepoetin Alfa for the Treatment of Anaemic Subjects With Low or Intermediate-1 Risk Myelodysplastic Syndrome), which is not on this map. Cited by 67 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
67citing papers in PubMed, 2 pooled it
7.9field-weighted citation impact, top 2% 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.

NCT01362140 phase3completednot on this map

A Multicenter, Randomised, Double-blind, Placebo-controlled Study of Darbepoetin Alfa for the Treatment of Anaemic Subjects With Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)

TypeinterventionalSponsorAmgenRan2011 to 2017Enrolled147ConditionsMDSArmsDarbepoetin alfa, Placebo
3 · Its place in the literature

Who cites it

67 citing papers in PubMed, 2 syntheses or guidelines pooled it, 126 citations in OpenAlex.

  1. Pooled it
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  7. Phase III, Randomized, Placebo-Controlled Trial of CC-486 (Oral Azacitidine) in Patients With Lower-Risk Myelodysplastic Syndromes.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2021
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  8. Lenalidomide-Epoetin Alfa Versus Lenalidomide Monotherapy in Myelodysplastic Syndromes Refractory to Recombinant Erythropoietin.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2021
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7 more citing papers are in PubMed but not listed here.

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

11 authors at 8 institutions in 8 countries.

U PlatzbeckerUniversity Hospital Carl Gustav Carus Dresden, Medizinische Klinik und Poliklinik I, Dresden, Germany.
A SymeonidisDivision of Hematology, Department of Internal Medicine, University of Patras Medical School, Patras, Greece.
E N OlivaDivision of Hematology, Azienda Ospedaliera Bianchi-Melacrino-Morelli, Reggio Calabria, Italy.
J S GoedeDivision of Hematology, University Hospital and University of Zürich, Zürich, Switzerland.
M DelforgeDepartment of Hematology &Chairman Leuven Cancer Institute, University Hospital Leuven, Leuven, Belgium.
J MayerDepartment of Internal Medicine-Hematology and Oncology, University Hospital Brno and Faculty of Medicine, Masaryk University, Brno, Czech Republic.
B SlamaOncologie Médicale-Hématologie Clinique, Centre Hospitalier Departemental, Avignon, France.
S BadreAmgen Inc., Thousand Oaks, CA, USA.
E GasalAmgen Inc., Thousand Oaks, CA, USA.
B MehtaAmgen Inc., Thousand Oaks, CA, USA.
J FranklinAmgen Inc., Thousand Oaks, CA, USA.
Amgen (United States) · USAzienda ospedaliera "Bianchi-Melacrino-Morelli" · ITHôpital Lyon Sud · FRKU Leuven · BEMasaryk University · CZUniversity Hospital Carl Gustav Carus · DEUniversity of Patras · GRUniversity of Zurich · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The use of darbepoetin alfa to treat anemia in patients with lower-risk myelodysplastic syndromes (MDS) was evaluated in a phase 3 trial. Eligible patients had low/intermediate-1 risk MDS, hemoglobin ⩽10 g/dl, low transfusion burden and serum erythropoietin (EPO) ⩽500 mU/ml. Patients were randomized 2:1 to receive 24 weeks of subcutaneous darbepoetin alfa 500 μg or placebo every 3 weeks (Q3W), followed by 48 weeks of open-label darbepoetin alfa. A total of 147 patients were randomized, with median hemoglobin of 9.3 (Q1:8.8, Q3:9.7) g/dl and median baseline serum EPO of 69 (Q1:36, Q3:158) mU/ml. Transfusion incidence from weeks 5-24 was significantly lower with darbepoetin alfa versus placebo (36.1% (35/97) versus 59.2% (29/49), P=0.008) and erythroid response rates increased significantly with darbepoetin alfa (14.7% (11/75 evaluable) versus 0% (0/35 evaluable), P=0.016). In the 48-week open-label period, dose frequency increased from Q3W to Q2W in 81% (102/126) of patients; this was associated with a higher hematologic improvement-erythroid response rate (34.7% (34/98)). Safety results were consistent with a previous darbepoetin alfa phase 2 MDS trial. In conclusion, 24 weeks of darbepoetin alfa Q3W significantly reduced transfusions and increased rates of erythroid response with no new safety signals in lower-risk MDS (registered as EudraCT#2009-016522-14 and NCT#01362140).

Indexed as

AgedAged, 80 and overAnemiaBlood TransfusionDarbepoetin alfaErythropoietinFemaleHemoglobinsHumansMaleMyelodysplastic SyndromesRiskDarbepoetin alfaEPO protein, humanErythropoietinHemoglobins

Identifiers

PMID28626220
PMCPMC5596208
OpenAlexW2674757831

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

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.