Evidence map›Paper›PMID 33439748›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2021

Lenalidomide-Epoetin Alfa Versus Lenalidomide Monotherapy in Myelodysplastic Syndromes Refractory to Recombinant Erythropoietin.

Alan F List, Zhuoxin Sun, Amit Verma, John M Bennett, Rami S Komrokji, Kathy McGraw, Jaroslaw Maciejewski, Jessica K Altman, Puneet S Cheema, David F Claxton and 7 more

Registry-linked trialAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02048813 (A Randomized Phase III Study of Ibrutinib), which is not on this map. Cited by 18 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 3 pooled it
–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.

NCT02048813 phase3active not recruitingnot on this map

A Randomized Phase III Study of Ibrutinib (PCI-32765)-Based Therapy vs Standard Fludarabine, Cyclophosphamide, and Rituximab (FCR) Chemoimmunotherapy in Untreated Younger Patients With Chronic Lymphocytic Leukemia (CLL)

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2014 to 2026Enrolled529ConditionsAnemia, Chronic Lymphocytic Leukemia, Small Lymphocytic LymphomaArmsCyclophosphamide, Fludarabine Phosphate, Ibrutinib, Laboratory Biomarker Analysis, Pharmacogenomic Study
3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 3 syntheses or guidelines pooled it.

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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

17 authors.

Alan F ListH. Lee Moffitt Cancer Center and Research Institute, Tampa, FL.
Zhuoxin SunDana Farber Cancer Institute-ECOG-ACRIN Biostatistics Center, Boston, MA.
Amit VermaAlbert Einstein College of Medicine, Montefiore Medical Center, Bronx, NY.ORCID 0000-0001-7592-7693
John M BennettUniversity of Rochester, New York, NY.
Rami S KomrokjiH. Lee Moffitt Cancer Center and Research Institute, Tampa, FL.ORCID 0000-0002-1876-5269
Kathy McGrawH. Lee Moffitt Cancer Center and Research Institute, Tampa, FL.
Jaroslaw MaciejewskiCleveland Clinic, Taussig Cancer Institute, Cleveland, OH.
Jessica K AltmanNorthwestern University, Chicago, IL.
Puneet S CheemaSaint John's Hospital, Maplewood, MN.ORCID 0000-0001-9024-9616
David F ClaxtonPenn State Cancer Center, Hershey, PA.ORCID 0000-0001-9209-2405
Selina M LugerUniversity of Pennsylvania, Philadelphia, PA.ORCID 0000-0003-3364-4366
Ryan J MattisonUniversity of Wisconsin, Madison, WI.
Timothy R WassenaarWaukesha Memorial Hospital, Waukesha, WI.
Andrew S ArtzCity of Hope National Medical Center, Duarte, CA.ORCID 0000-0003-0803-9607
Charles A SchifferKarmanos Cancer Institute, Wayne State University, Detroit, MI.
Mark R LitzowMayo Clinic, Rochester, MN.
Martin S TallmanLeukemia Service, Memorial Sloan Kettering Cancer Center, Weill Cornell Medical College, New York, NY.

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
Project-006U10CA180820 · NCI · ECOG-ACRIN MEDICAL RESEARCH FOUNDATION · PI Peter J ODwyer, MITCHELL D. SCHNALL · 2014 to 2026
$167.6M
SWOG Network Group Operations Center of the NCTNU10CA180888 · NCI · UNIVERSITY OF CALIFORNIA AT DAVIS · PI PRIMO N. LARA · 2014 to 2026
$152.1M
Statistics CoreU10CA180794 · NCI · DANA-FARBER CANCER INST · PI PAUL J CATALANO, CONSTANTINE A. GATSONIS · 2014 to 2026
$111.2M
ECOG-ACRIN Biospecimen Bank to Support NCTNU24CA196172 · NCI · ECOG-ACRIN MEDICAL RESEARCH FOUNDATION · PI STANLEY R. HAMILTON, Scott D Jewell · 2015 to 2026
$41.1M
Network Lead Academic Participating Site: Memorial Sloan Kettering Cancer CenterUG1CA233290 · NCI · SLOAN-KETTERING INST CAN RESEARCH · PI CAROL AGHAJANIAN, Darren Feldman · 2019 to 2026
$10.2M
National Clinical Trials Network Research at the University of WisconsinUG1CA233277 · NCI · UNIVERSITY OF WISCONSIN-MADISON · PI Lisa M Barroilhet, Andrew M. Baschnagel · 2019 to 2026
$4.9M
Phosphatase Targets of Lenalidomide in Myelodysplastic SyndromeR01CA131076 · NCI · H. LEE MOFFITT CANCER CTR & RES INST · PI LIST, ALAN F · 2008 to 2012
$2.2M
NCI NIH HHS P30 CA008748NCI NIH HHS R01 CA131076NCI NIH HHS U10 CA180794NCI NIH HHS U10 CA180820NCI NIH HHS U10 CA180888NCI NIH HHS U24 CA196172NCI NIH HHS UG1 CA233277NCI NIH HHS UG1 CA233290
6 · The paper itself

Abstract

purposeImpaired response to erythropoietin underlies ineffective erythropoiesis and anemia in myelodysplastic syndromes (MDS). We investigated whether treatment with lenalidomide (LEN), which augments erythropoietin receptor signaling in vitro, can restore and improve hemoglobin response to epoetin (EPO) alfa in patients with lower-risk, non-del(5q) MDS who have anemia that is refractory to or have low probability of benefit from treatment with recombinant erythropoietin.

methodsIn a phase III, US intergroup trial, we randomly assigned patients to receive either LEN and EPO alfa or LEN alone following stratification by serum erythropoietin concentration and prior erythropoietin treatment.

resultsA total of 195 evaluable patients were randomly assigned: 99 patients to the LEN-EPO alfa cohort and 96 to LEN alone. After four cycles of treatment, the primary end point of major erythroid response (MER) was significantly higher (28.3%) with the combination compared with LEN alone (11.5%) (

conclusionLEN restores sensitivity to recombinant erythropoietin in growth factor-insensitive, lower-risk, non-del(5q) MDS, to yield a significantly higher rate and duration of MER compared with LEN alone (funded by the National Cancer Institute; E2905 ClinicalTrials.gov identifier: NCT02048813).

Indexed as

AgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsDrug Resistance, NeoplasmEpoetin AlfaFemaleFollow-Up StudiesHumansLenalidomideMaleMiddle AgedMyelodysplastic SyndromesNeoplasm Recurrence, LocalPrognosisRecombinant ProteinsSurvival RateEpoetin AlfaLenalidomideRecombinant Proteins

Identifiers

PMID33439748
PMCPMC8274743

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.