Evidence map›Paper›PMID 28224300›Full record

Trial reportJournal of cancer research and clinical oncology2017

Nilotinib first-line therapy in patients with Philadelphia chromosome-negative/BCR-ABL-positive chronic myeloid leukemia in chronic phase: ENEST1st sub-analysis.

Andreas Hochhaus, Franҫois-Xavier Mahon, Philipp le Coutre, Ljubomir Petrov, Jeroen J W M Janssen, Nicholas C P Cross, Delphine Rea, Fausto Castagnetti, Andrzej Hellmann, Gianantonio Rosti and 7 more

Open access · hybridAbstract readClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in Journal of cancer research and clinical oncology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.1field-weighted citation impact, top 23% 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

5 citing papers in PubMed, 10 citations in OpenAlex.

  1. Review
  2. Article
  3. 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

17 authors at 13 institutions in 9 countries.

Andreas HochhausAbteilung Hämatologie/Onkologie, Klinik für Innere Medizin II, Universitätsklinikum Jena, Am Klinikum 1, 07740, Jena, Germany. andreas.hochhaus@med.uni-jena.de.
Franҫois-Xavier MahonLaboratoire Hématopoïèse Leucémique et Cible Thérapeutique, Université Victor Ségalen, Bordeaux, France.
Philipp le CoutreCharité-Universitätsmedizin Berlin Campus Virchow, Berlin, Germany.
Ljubomir PetrovIon Chiricuta Institute of Oncology, Cluj-Napoca, Romania.
Jeroen J W M JanssenDepartment of Hematology, VU University Medical Center, Amsterdam, The Netherlands.
Nicholas C P CrossFaculty of Medicine, University of Southampton, Southampton, UK.
Delphine ReaAdult Hematology Department, Hôpital Saint-Louis, APHP, Paris, France.
Fausto CastagnettiDepartment of Experimental, Diagnostic and Specialty Medicine, Institute of Hematology "L. & A. Seràgnoli", "S Orsola-Malpighi" University Hospital, University of Bologna, Bologna, Italy.
Andrzej HellmannDepartment of Hematology, Medical University of Gdańsk, Gdańsk, Poland.
Gianantonio RostiDepartment of Experimental, Diagnostic and Specialty Medicine, Institute of Hematology "L. & A. Seràgnoli", "S Orsola-Malpighi" University Hospital, University of Bologna, Bologna, Italy.
Norbert GattermannDepartment of Hematology, Oncology, and Clinical Immunology, Universitätsklinikum Düsseldorf, Düsseldorf, Germany.
Maria Liz Paciello CoronelServicio de Hematología y Hemoterapia, IRYCIS, Hospital Universitario Ramón y Cajal, Madrid, Spain.
Maria Asuncion Echeveste GutierrezHospital de Donostia, San Sebastian, Spain.
Valentin Garcia-GutierrezServicio de Hematología y Hemoterapia, IRYCIS, Hospital Universitario Ramón y Cajal, Madrid, Spain.
Beatrice VincenziNovartis Oncology Region Europe, Origgio, Italy.
Luca DezzaniNovartis Oncology Region Europe, Origgio, Italy.
Francis J GilesDivision of Hematology Oncology, Developmental Therapeutics Program, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
Instituto Ramón y Cajal de Investigación Sanitaria · ESNovartis (Italy) · ITUniversity of Bologna · ITAmsterdam UMC Location VUmc · NLBiogipuzkoa Health Research Institute · ESCharité - Universitätsmedizin Berlin · DEGdańsk Medical University · PLHeinrich Heine University Düsseldorf · DEHôpital Saint-Louis · FRInstitute of Oncology Prof. Dr. Ion Chiricuta · ROJena University Hospital · DENorthwestern University · USUniversity of Southampton · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe ENEST1st sub-analysis presents data based on Philadelphia chromosome (Ph) status, i.e., Ph+ and Ph-/BCR-ABL1 + chronic myeloid leukemia.

methodsPatients received nilotinib 300 mg twice daily, up to 24 months.

resultsAt screening, 983 patients were identified as Ph+ and 30 patients as Ph-/BCR-ABL + based on cytogenetic and RT-PCR assessment; 76 patients had unknown karyotype (excluded from this sub-analysis). In the Ph-/BCR-ABL1 + subgroup, no additional chromosomal aberrations were reported. In the Ph+ subgroup, 952 patients had safety and molecular assessments. In the Ph-/BCR-ABL1 + subgroup, 30 patients had safety assessments and 28 were followed up for molecular assessments. At 18 months, the molecular response (MR) 4 rate [MR

conclusionBased on similar molecular response and safety results in both subgroups, we conclude that Ph-/BCR-ABL1 + patients benefit from nilotinib in the same way as Ph+ patients.

Indexed as

AdolescentAdultAgedAntineoplastic AgentsFemaleFusion Proteins, bcr-ablHumansLeukemia, Myeloid, Chronic, Atypical, BCR-ABL NegativeMaleMiddle AgedMultiplex Polymerase Chain ReactionPhiladelphia ChromosomeProtein Kinase InhibitorsPyrimidinesReal-Time Polymerase Chain ReactionYoung AdultAntineoplastic AgentsFusion Proteins, bcr-ablnilotinibProtein Kinase InhibitorsPyrimidinesChronic myeloid leukemiaENEST1stNilotinibPhiladelphia chromosome negative/BCR-ABL positive

Identifiers

PMID28224300
PMCPMC5486575
OpenAlexW2590158197

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Registered trials

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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.