Evidence map›Paper›PMID 28651604›Full record

Trial reportJournal of hematology & oncology2017

Clinical characteristics and outcomes according to age in lenalidomide-treated patients with RBC transfusion-dependent lower-risk MDS and del(5q).

Pierre Fenaux, Aristoteles Giagounidis, Dominik Selleslag, Odile Beyne-Rauzy, Moshe Mittelman, Petra Muus, Stephen D Nimer, Eva Hellström-Lindberg, Bayard L Powell, Agnes Guerci-Bresler and 8 more

2 registry-linked trialsAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in Journal of hematology & oncology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–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.

NCT00065156 phase2completednot on this map

A Multicenter, Single-arm, Open-label Study of the Efficacy and Safety of Lenalidomide Monotherapy in Red Blood Cell Transfusion-dependent Subjects With Myelodysplastic Syndromes Associated With a Del(5q) Cytogenetic Abnormality.

TypeinterventionalSponsorCelgeneRan2003 to 2008Enrolled148ConditionsMyelodysplastic SyndromesArmslenalidomide
NCT00179621 phase3completednot on this map

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, 3-Arm Study of the Efficacy and Safety of 2 Doses of Lenalidomide Versus Placebo in Red Blood Cell (RBC) Transfusion-Dependent Subjects With Low- or Intermediate-1-Risk Myelodysplastic Syndromes Associated With a Deletion (Del) 5q[31] Cytogenetic Abnormality

TypeinterventionalSponsorCelgene CorporationRan2005 to 2010Enrolled205ConditionsMyelodysplastic SyndromesArmsLenalidomide 5 mg, Lenalidomide 10 mg, Placebo
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Infections in Myelodysplastic Syndrome in Relation to Stage and Therapy.Mediterranean journal of hematology and infectious diseases · 2018
    Review
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

18 authors.

Pierre FenauxService d'Hématologie Séniors, Hôpital Saint-Louis, Université Paris 7, 1 Avenue Claude Vellefaux, 75475, Paris, France. pierre.fenaux@aphp.fr.
Aristoteles GiagounidisMarien Hospital Düsseldorf, Düsseldorf, Germany.
Dominik SelleslagAZ St-Jan BruggeAV, Brugge, Belgium.
Odile Beyne-RauzyPurpan Pavillion de Medecines, Centre Hospitalier Universitaire, Toulouse, France.
Moshe MittelmanTel Aviv Sourasky Medical Center, Tel Aviv, Israel.
Petra MuusRadboud University Medical Centre, Nijmegen, The Netherlands.
Stephen D NimerSylvester Comprehensive Cancer Center, University of Miami, Miami, FL, USA.
Eva Hellström-LindbergKarolinska University Hospital, Stockholm, Sweden.
Bayard L PowellComprehensive Cancer Center of Wake Forest University, Winston-Salem, NC, USA.
Agnes Guerci-BreslerCHU Brabois, University Center of Medicine, Vandoeuvre, France.
Mikkael A SekeresCleveland Clinic, Cleveland, OH, USA.
H Joachim DeegFred Hutchinson Cancer Research Center, Seattle, WA, USA.
Consuelo Del CañizoHospital Universitario de Salamanca, Salamanca, Spain.
Peter L GreenbergStanford Cancer Institute, Stanford, CA, USA.
Jamile M ShammoRush University Medical Center, Chicago, IL, USA.
Barry SkikneCelgene Corporation, Summit, NJ, USA.
Xujie YuCelgene Corporation, Summit, NJ, USA.
Alan F ListH. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundParticularly since the advent of lenalidomide, lower-risk myelodysplastic syndromes (MDS) patients with del(5q) have been the focus of many studies; however, the impact of age on disease characteristics and response to lenalidomide has not been analyzed.

methodsWe assessed the effect of age on clinical characteristics and outcomes in 286 lenalidomide-treated MDS patients with del(5q) from two multicenter trials.

resultsA total of 33.9, 34.3, and 31.8% patients were aged <65 years, ≥65 to <75 years, and ≥75 years, respectively. Age <65 years was associated with less favorable International Prognostic Scoring System (IPSS) risk and additional cytopenias at baseline versus older age groups, significantly lower cytogenetic response rates (p = 0.022 vs. ≥65 to <75 years; p = 0.047 vs. ≥75 years), and higher rates of acute myeloid leukemia (AML) progression (Gray's test, p = 0.013). Lenalidomide was equally well tolerated across age groups, producing consistently high rates of red blood cell transfusion independence ≥26 weeks.

conclusionsBaseline disease characteristics and AML progression appear to be more severe in younger lower-risk MDS patients with del(5q), whereas older age does not seem to compromise the response to lenalidomide.

trial registrationClinicalTrials.gov NCT00065156 and NCT00179621.

Indexed as

AdultAgedAged, 80 and overAge FactorsChromosomes, Human, Pair 5CytogeneticsDisease ProgressionErythrocyte TransfusionFemaleHumansImmunologic FactorsLenalidomideLeukemia, Myeloid, AcuteMaleMiddle AgedMyelodysplastic SyndromesImmunologic FactorsLenalidomideThalidomideAcute myeloid leukemiaAgedel(5q)LenalidomideMyelodysplastic syndromes

Identifiers

PMID28651604
PMCPMC5485496

What OpenQuestion holds

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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.