Evidence map›Paper›PMID 29895954›Full record

Trial reportLeukemia2018

A phase 3 randomized, placebo-controlled study assessing the efficacy and safety of epoetin-α in anemic patients with low-risk MDS.

Pierre Fenaux, Valeria Santini, Maria Antonietta Aloe Spiriti, Aristoteles Giagounidis, Rudolf Schlag, Atanas Radinoff, Liana Gercheva-Kyuchukova, Achilles Anagnostopoulos, Esther Natalie Oliva, Argiris Symeonidis and 7 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Leukemia, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07539779 (The Efficacy and Safety of Luspatercept in Preventing Poor Erythroid Engraftment After Allo-HSCT for Hematological Malignancies With Moderate to Severe Myelofibrosis), which is not on this map. Cited by 79 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
79citing papers in PubMed, 1 pooled it
10.8field-weighted citation impact, top 1% 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.

NCT07539779 phase2 / phase3not yet recruitingnot on this mapstarted 2026, after this paper: background citation

The Efficacy and Safety of Luspatercept in Preventing Poor Erythroid Engraftment After Allo-HSCT for Hematological Malignancies With Moderate to Severe Myelofibrosis: A Prospective, Multicenter, Randomized Controlled Study

TypeinterventionalSponsorNanfang Hospital, Southern Medical UniversityRan2026 to 2030Enrolled196ConditionsLuspatercept, Poor Erythroid Engraftment, Hematological Malignancies, Myelofibrosis (MF)ArmsLuspatercept, Control
3 · Its place in the literature

Who cites it

79 citing papers in PubMed, 1 synthesis or guideline pooled it, 159 citations in OpenAlex.

  1. Pooled it
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  6. 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
    Trial
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  8. Article
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  11. Molecular and therapeutic frontiers in anemia therapy.The Journal of clinical investigation · 2026
    Review
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  17. Updates in low/intermediate-risk MDS.Hematology. American Society of Hematology. Education Program · 2025
    Review
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  20. Article

19 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

17 authors at 15 institutions in 7 countries.

Pierre FenauxHôpital St. Louis, Assistance Publique Hôpitaux de Paris, Université Paris Diderot, Paris, France. pierre.fenaux@aphp.fr.
Valeria SantiniHematology AOU Careggi, University of Florence, Florence, Italy.
Maria Antonietta Aloe SpiritiSapienza Università di Roma, Rome, Italy.
Aristoteles GiagounidisMarien Hospital, Düsseldorf, Germany.
Rudolf SchlagPraxisklinik Würzburg, Würzburg, Germany.
Atanas RadinoffUniversity Hospital Sveti Ivan Rislki, Sofia, Bulgaria.
Liana Gercheva-KyuchukovaVarna Clinic of Haematology, Varna, Bulgaria.
Achilles AnagnostopoulosGeorge Papanicolaou Hospital, Thessaloniki, Greece.
Esther Natalie OlivaGrande Ospedale Metropolitano Bianchi-Melacrino-Morelli, Calabria, Italy.
Argiris SymeonidisDepartment of Hematology, Medical School, University of Patras, Patras, Greece.
Mathilde Hunault BergerCHU Angers, Angers, France.
Katharina S GötzeTechnische Universität München, Munich, Germany.
Anna PotamianouEMEA Medical Affairs, Janssen-Cilag, Neuss, Germany.
Hari HaralampievEMEA Medical Affairs, Covance CoSource on assignment with Janssen, Sofia, Bulgaria.
Robert WapenaarBiostatistics, Janssen-Cilag BV, Breda, The Netherlands.
Iordanis MilionisEMEA Medical Affairs, Janssen-Cilag Pharmaceutical SACI, Athens, Greece.
Uwe PlatzbeckerMedizinische Klinik und Poliklinik I, Dresden, Germany.
Assistance Publique – Hôpitaux de Paris · FRAthens Medical Center · GRAzienda ospedaliera "Bianchi-Melacrino-Morelli" · ITCentre Hospitalier Universitaire d'Angers · FRCovance (United States) · USG. Papanikolaou General Hospital · GRJanssen (Germany) · DEJanssen (Netherlands) · NLMarien Hospital Düsseldorf · DEMedical University of Varna · BGSapienza University of Rome · ITTechnical University of Munich · DEUniversity Hospital St. Ivan Rilski · BGUniversity of Florence · ITUniversity of Patras · GR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Erythropoiesis-stimulating agents are first choice for treating anemia in low-risk MDS. This double-blind, placebo-controlled study assessed the efficacy and safety of epoetin-α in IPSS low- or intermediate-1 risk (i.e., low-risk) MDS patients with Hb ≤ 10.0 g/dL, with no or moderate RBC transfusion dependence (≤4 RBC units/8 weeks). Patients were randomized, 2:1, to receive epoetin-α 450 IU/kg/week or placebo for 24 weeks, followed by treatment extension in responders. The primary endpoint was erythroid response (ER) through Week 24. Dose adjustments were driven by weekly Hb-levels and included increases, and dose reductions/discontinuation if Hb > 12 g/dL. An independent Response Review Committee (RRC) blindly reviewed all responses, applying IWG-2006 criteria but also considering dose adjustments, drug interruptions and longer periods of observation.A total of 130 patients were randomized (85 to epoetin-α and 45 to placebo). The ER by IWG-2006 criteria was 31.8% for epoetin-α vs 4.4% for placebo (p < 0.001); after RRC review, the ER was 45.9 vs 4.4% (p < 0.001), respectively. Epoetin-α reduced RBC transfusions and increased the time-to-first-transfusion compared with placebo.Thus, epoetin-α significantly improved anemia outcomes in low-risk MDS. IWG-2006 criteria for ER may require amendments to better apply to clinical studies.

Indexed as

AdultAgedAged, 80 and overAnemiaBlood TransfusionDouble-Blind MethodDrug Administration ScheduleEpoetin AlfaErythropoietinFemaleHematinicsHemoglobinsHumansMaleMiddle AgedMyelodysplastic SyndromesEpoetin AlfaErythropoietinHematinicsHemoglobins

Identifiers

PMID29895954
PMCPMC6286328
OpenAlexW2794499016

What OpenQuestion holds

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LicenceCC BY
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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.