Evidence map›Paper›PMID 26500139›Full record

Trial reportLeukemia2016

Lenalidomide with or without erythropoietin in transfusion-dependent erythropoiesis-stimulating agent-refractory lower-risk MDS without 5q deletion.

A Toma, O Kosmider, S Chevret, J Delaunay, A Stamatoullas, C Rose, O Beyne-Rauzy, A Banos, A Guerci-Bresler, S Wickenhauser and 32 more

Open access · bronzeAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Leukemia, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 56 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
56citing papers in PubMed, 2 pooled it
8.8field-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.

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

56 citing papers in PubMed, 2 syntheses or guidelines pooled it, 120 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. 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
    Trial
  5. A variant erythroferrone disrupts iron homeostasis inScience translational medicine · 2019
    Trial
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  7. Trial
  8. Article
  9. Review
  10. Article
  11. Review
  12. Article
  13. Treatment of Anemia in Lower-Risk Myelodysplastic Syndrome.Current treatment options in oncology · 2024
    Review
  14. Role of reactive oxygen species in myelodysplastic syndromes.Cellular & molecular biology letters · 2024
    Review
  15. Review
  16. Review
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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

42 authors at 20 institutions in 1 country.

A TomaDepartment of Hematology, Hopital Universitaire Henri Mondor, Assistance Publique-Hôpitaux de Paris (APHP) and Paris 12 University, Creteil, France.
O KosmiderAssistance Publique-Hopitaux de Paris, Hopital Cochin, Laboratory of Hematology and Paris Descartes University, Paris, France.
S ChevretBiostatistics Team (ECSTRA), UMR1153, Inserm, Hopital Saint Louis, APHP and Paris 7 University, Paris, France.
J DelaunayDepartment of Hematology, Centre Hospitalier Universitaire, Nantes, France.
A StamatoullasDepartment of Hematology, Centre Henri Becquerel, Rouen, France.
C RoseDepartment of Hematology, Hopital Saint Vincent de Paul, Lomme, France.
O Beyne-RauzyDepartment of Hematology, Centre Hospitalier Universitaire, Purpan, France.
A BanosDepartment of Hematology, Centre Hospitalier Universitaire, Strasbourg, France.
A Guerci-BreslerDepartment of Hematology, Centre Hospitalier Universitaire, Nancy, France.
S WickenhauserDepartment of Hematology, Centre Hospitalier Universitaire, Nimes, France.
D CaillotDepartment of Hematology, Centre Hospitalier Universitaire, Dijon, France.
K LaribiDepartment of Hematology, Centre Hospitalier, Le Mans, France.
B De RenzisDepartment of Hematology, Centre Hospitalier Universitaire, Clermont Ferrand, France.
D BordessouleDepartment of Hematology, Centre Hospitalier Universitaire, Limoges, France.
C GardinDepartment of Hematology, Hopital Avicenne, APHP, and Paris 13 University Bobigny, Bobigny, France.
B SlamaDepartment of Hematology, Centre Hospitalier, Avignon, France.
L SanhesDepartment of Hematology, Centre Hospitalier, Perpignan, France.
B GrusonDepartment of Hematology, Hopital Universitaire Amiens, Amiens, France.
P Cony-MakhoulDepartment of Hematology, Centre Hospitalier Annecy-Genevois, Prigny, France.
B ChouffiDepartment of Hematology, Centre Hospitalier, Boulogne sur Mer, France.
C SalanoubatDepartment of Hematology, Centre Hospitalier, Corbeil, France.
R BenramdaneDepartment of Hematology, Centre Hospitalier, Pontoise, France.
L LegrosDepartment of Hematology, Centre Hospitalier Universitaire, Nice, France.
E WattelDepartment of Hematology, Centre Hospitalier Edouard Herriot, Lyon, France.
G TertianDepartment of Hematology, Hopital Kremlin Bicetre, APHP, Kremlin Bicetre, France.
K BouabdallahDepartment of Hematology, Centre Hospitalier Universitaire, Bordeaux, France.
F GuilhotDepartment of Hematology, Centre Hospitalier Jean Bernard, Poitiers, France.
A L TaksinDepartment of Hematology, Centre Hospitalier, Versailles, France.
S ChezeDepartment of Hematology, Centre Hospitalier Universitaire, Caen, France.
K MaloumDepartment of Hematology, Hopital Pitie Salpetriere, APHP and Paris 6 University Paris, Paris, France.
S NimubomaDepartment of Hematology, Centre Hospitalier Universitaire, Rennes, France.
C SoussainDepartment of Oncology, Centre Rene Huguenin, Saint Cloud, France.
F IsnardDepartment of Hematology, Hopital Saint Antoine, APHP, and Paris 6 University Paris, Paris, France.
E GyanDepartment of Hematology, Centre Hospitalier Universitaire, Tours, France.
R PetitDepartement de Recherche Clinique, Hopital Saint Louis, APHP, Paris, France.
J LejeuneBiostatistics Team (ECSTRA), UMR1153, Inserm, Hopital Saint Louis, APHP and Paris 7 University, Paris, France.
V SardnalAssistance Publique-Hopitaux de Paris, Hopital Cochin, Laboratory of Hematology and Paris Descartes University, Paris, France.
A RennevilleDepartment of Biology, Centre Hospitalier Universitaire, Lille, France.
C PreudhommeDepartment of Biology, Centre Hospitalier Universitaire, Lille, France.
M FontenayAssistance Publique-Hopitaux de Paris, Hopital Cochin, Laboratory of Hematology and Paris Descartes University, Paris, France.
P FenauxDepartment of Hematology, Service Hematologie Seniors, Hopital Saint Louis, APHP, and Paris 7 University Paris, Paris, France.
F DreyfusDepartment of Hematology, Hopital Cochin, APHP, and Paris 5 University Paris, Paris, France.
Assistance Publique – Hôpitaux de Paris · FRCentre Hospitalier Universitaire de Lille · FRUniversité Paris Cité · FRBicêtre Hospital · FRCentre Hospitalier Annecy Genevois · FRCentre Hospitalier de Perpignan · FRCentre Hospitalier de Versailles · FRCentre Hospitalier du Mans · FRCentre Hospitalier Laennec · FRCentre Hospitalier Régional et Universitaire de Nancy · FRCentre Hospitalier René-Dubos · FRCentre Hospitalier Universitaire Amiens-Picardie · FRCentre Hospitalier Universitaire de Bordeaux · FRCentre Hospitalier Universitaire de Caen Normandie · FRCentre Hospitalier Universitaire de Clermont-Ferrand · FRCentre Hospitalier Universitaire de Limoges · FRCentre Hospitalier Universitaire de Nantes · FRCentre Hospitalier Universitaire de Nice · FRCentre Hospitalier Universitaire de Nîmes · FRCentre Hospitalier Universitaire de Rennes · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

After failure of erythropoiesis-stimulating agents (ESAs), lenalidomide (LEN) yields red blood cell (RBC) transfusion independence (TI) in 20-30% of lower-risk non-del5q myelodysplastic syndrome (MDS). Several observations suggest an additive effect of ESA and LEN in this situation. We performed a randomized phase III study in 131 RBC transfusion-dependent (TD, median transfusion requirement six RBC units per 8 weeks) lower-risk ESA-refractory non-del5q MDS. Patients received LEN alone, 10 mg per day, 21 days per 4 weeks (L arm) or LEN (same schedule) + erythropoietin (EPO) beta, 60,000 U per week (LE arm). In an intent-to-treat (ITT) analysis, erythroid response (HI-E, IWG 2006 criteria) after four treatment cycles (primary end point) was 23.1% (95% CI 13.5-35.2) in the L arm and 39.4% (95% CI 27.6-52.2) in the LE arm (P=0.044), while RBC-TI was reached in 13.8 and 24.2% of the patients in the L and LE arms, respectively (P=0.13). Median response duration was 18.1 and 15.1 months in the L and LE arms, respectively (P=0.47). Side effects were moderate and similar in the two arms. Low baseline serum EPO level and a G polymorphism of CRBN gene predicted HI-E. Combining LEN and EPO significantly improves erythroid response over LEN alone in lower-risk non-del5q MDS patients with anemia resistant to ESA.

Indexed as

Blood TransfusionChromosome DeletionAgedAnemiaAngiogenesis InhibitorsChromosomes, Human, Pair 5Drug Therapy, CombinationErythropoietinFemaleFollow-Up StudiesHumansLenalidomideMaleMiddle AgedMyelodysplastic SyndromesNeoplasm StagingAngiogenesis InhibitorsErythropoietinLenalidomideThalidomide

Identifiers

PMID26500139
OpenAlexW2236991441

What OpenQuestion holds

Textmetadata
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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.