Evidence map›Paper›PMID 29097499›Full record

Trial reportHaematologica2018

Randomized study of continuous high-dose lenalidomide, sequential azacitidine and lenalidomide, or azacitidine in persons 65 years and over with newly-diagnosed acute myeloid leukemia.

Bruno C Medeiros, Kelly McCaul, Suman Kambhampati, Daniel A Pollyea, Rajat Kumar, Lewis R Silverman, Andrea Kew, Lalit Saini, C L Beach, Ravi Vij and 3 more

Open access · goldAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Haematologica, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 3 pooled it
1.6field-weighted citation impact, top 15% 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

14 citing papers in PubMed, 3 syntheses or guidelines pooled it, 21 citations in OpenAlex.

  1. Pooled it
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  3. Pooled it
  4. Trial
  5. Trial
  6. Review
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  13. Key actors in cancer therapy: epigenetic modifiers.Turkish journal of biology = Turk biyoloji dergisi · 2019
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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

13 authors at 10 institutions in 3 countries.

Bruno C MedeirosStanford University School of Medicine, CA, USA brunom@stanford.edu.
Kelly McCaulAvera Cancer Institute, Sioux Falls, SD, USA.
Suman KambhampatiSarah Cannon Cancer Institute at Research Medical Center, Kansas City, MO, USA.
Daniel A PollyeaUniversity of Colorado School of Medicine Division of Hematology, Aurora, CO, USA.
Rajat KumarCancerCare Manitoba, Winnipeg, MB, Canada.
Lewis R SilvermanMount Sinai Hospital, New York, NY, USA.
Andrea KewQueen Elizabeth II Health Sciences Center, Halifax, NS, Canada.
Lalit SainiUniversity of Alberta Hospital (Adult Hematology Research), Edmonton, AB, Canada.
C L BeachCelgene Corporation, Summit, NJ, USA.
Ravi VijSection of Bone Marrow Transplant and Leukemia, Washington University School of Medicine, St Louis, MO, USA.
Xiwei WangCelgene Corporation, Summit, NJ, USA.
Jim ZhongCelgene Corporation, Summit, NJ, USA.
Robert Peter GaleCelgene Corporation, Summit, NJ, USA.
Avera Health · USCancerCare Manitoba · CAImperial College London · GBMount Sinai Hospital · USQueen Elizabeth II Health Sciences Centre · CAStanford University · USUniversity Hospital and Clinics · USUniversity of Alberta Hospital · CAUniversity of Colorado Denver · USWashington University in St. Louis · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Therapy of acute myeloid leukemia in older persons is associated with poor outcomes because of intolerance to intensive therapy, resistant disease and co-morbidities. This multi-center, randomized, open-label, phase II trial compared safety and efficacy of three therapeutic strategies in patients 65 years or over with newly-diagnosed acute myeloid leukemia: 1) continuous high-dose lenalidomide (n=15); 2) sequential azacitidine and lenalidomide (n=39); and 3) azacitidine only (n=34). The efficacy end point was 1-year survival. Median age was 76 years (range 66-87 years). Thirteen subjects (15%) had prior myelodysplastic syndrome and 41 (47%) had adverse cytogenetics. One-year survival was 21% [95% confidence interval (CI): 0, 43%] with high-dose lenalidomide, 44% (95%CI: 28, 60%) with sequential azacitidine and lenalidomide, and 52% (95%CI: 35, 70%) with azacitidine only. Lenalidomide at a continuous high-dose schedule was poorly-tolerated resulting in a high rate of early therapy discontinuations. Hazard of death in the first four months was greatest in subjects receiving continuous high-dose lenalidomide; hazards of death thereafter were similar. These data do not favor use of continuous high-dose lenalidomide or sequential azacitidine and lenalidomide over the conventional dose and schedule of azacitidine only in patients aged 65 years or over with newly-diagnosed acute myeloid leukemia. (

Indexed as

AgedAged, 80 and overAge FactorsAntineoplastic Combined Chemotherapy ProtocolsAzacitidineFemaleHumansKaplan-Meier EstimateLenalidomideLeukemia, Myeloid, AcuteMaleProportional Hazards ModelsTreatment OutcomeAzacitidineLenalidomide

Identifiers

PMID29097499
PMCPMC5777197
OpenAlexW2766970124

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.