Evidence map›Paper›PMID 25676422›Full record

Trial reportLeukemia2015

Safety and efficacy of imatinib in CML over a period of 10 years: data from the randomized CML-study IV.

L Kalmanti, S Saussele, M Lauseker, M C Müller, C T Dietz, L Heinrich, B Hanfstein, U Proetel, A Fabarius, S W Krause and 15 more

Abstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Leukemia, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 152 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
152citing papers in PubMed, 1 pooled it
22.7field-weighted citation impact, top 1% 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

152 citing papers in PubMed, 1 synthesis or guideline pooled it, 273 citations in OpenAlex.

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92 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

25 authors at 13 institutions in 2 countries.

L KalmantiIII. Medizinische Klinik, Medizinische Fakultät Mannheim, Universität Heidelberg, Mannheim, Germany.
S SausseleIII. Medizinische Klinik, Medizinische Fakultät Mannheim, Universität Heidelberg, Mannheim, Germany.
M LausekerInstitut für Medizinische Informationsverarbeitung, Biometrie und Epidemiologie, Ludwig-Maximilians-Universität, München, Germany.
M C MüllerIII. Medizinische Klinik, Medizinische Fakultät Mannheim, Universität Heidelberg, Mannheim, Germany.
C T DietzIII. Medizinische Klinik, Medizinische Fakultät Mannheim, Universität Heidelberg, Mannheim, Germany.
L HeinrichIII. Medizinische Klinik, Medizinische Fakultät Mannheim, Universität Heidelberg, Mannheim, Germany.
B HanfsteinIII. Medizinische Klinik, Medizinische Fakultät Mannheim, Universität Heidelberg, Mannheim, Germany.
U ProetelIII. Medizinische Klinik, Medizinische Fakultät Mannheim, Universität Heidelberg, Mannheim, Germany.
A FabariusIII. Medizinische Klinik, Medizinische Fakultät Mannheim, Universität Heidelberg, Mannheim, Germany.
S W KrauseMedizinische Klinik 5, Universitätsklinikum, Erlangen, Germany.
S RinaldettiIII. Medizinische Klinik, Medizinische Fakultät Mannheim, Universität Heidelberg, Mannheim, Germany.
J DenglerMedizinische Klinik V, Universitätsklinikum, Heidelberg, Germany.
C FalgeMedizinische Klinik 5, Klinikum Nürnberg Nord, Nürnberg, Germany.
E Oppliger-LeibundgutUniversitätsklinik für Hämatologie, Inselspital, Bern, Switzerland.
A BurchertKlinik für Innere Medizin, Universitätsklinikum, Marburg, Germany.
A NeubauerKlinik für Innere Medizin, Universitätsklinikum, Marburg, Germany.
L KanzMedizinische Klinik II, Universitätsklinikum, Tübingen, Germany.
F StegelmannKlinik für Innere Medizin III, Universitätsklinikum, Ulm, Germany.
M PfreundschuhInnere Medizin I, Universitätsklinikum des Saarlandes, Homburg/Saar, Germany.
K SpiekermannMedizinische Klinik und Poliklinik III, Ludwig-Maximilians-Universität, München, Germany.
C ScheidKlinik I für Innere Medizin, Universitätsklinikum, Köln, Germany.
M PfirrmannInstitut für Medizinische Informationsverarbeitung, Biometrie und Epidemiologie, Ludwig-Maximilians-Universität, München, Germany.
A HochhausKlinik für Innere Medizin II, Universitätsklinikum, Jena, Germany.
J HasfordInstitut für Medizinische Informationsverarbeitung, Biometrie und Epidemiologie, Ludwig-Maximilians-Universität, München, Germany.
R HehlmannIII. Medizinische Klinik, Medizinische Fakultät Mannheim, Universität Heidelberg, Mannheim, Germany.
Heidelberg University · DELudwig-Maximilians-Universität München · DEMedizinische Fakultät MannheimJena University Hospital · DENuremberg Hospital · DEUniversitätsklinikum des Saarlandes · DEUniversitätsklinikum Erlangen · DEUniversitätsklinikum Tübingen · DEUniversity Hospital Cologne · DEUniversity Hospital Heidelberg · DEUniversity Hospital of Bern · CHUniversity Hospital Ulm · DEZimmer Biomet (Germany) · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Tyrosine kinase inhibitors (TKI) have changed the natural course of chronic myeloid leukemia (CML). With the advent of second-generation TKI safety and efficacy issues have gained interest. The randomized CML - Study IV was used for a long-term evaluation of imatinib (IM). 1503 patients have received IM, 1379 IM monotherapy. After a median observation of 7.1 years, 965 patients (64%) still received IM. At 10 years, progression-free survival was 82%, overall survival 84%, 59% achieved MR(5), 72% MR(4.5), 81% MR(4), 89% major molecular remission and 92% MR(2) (molecular equivalent to complete cytogenetic remission). All response levels were reached faster with IM800 mg except MR(5). Eight-year probabilities of adverse drug reactions (ADR) were 76%, of grades 3-4 22%, of non-hematologic 73%, and of hematologic 28%. More ADR were observed with IM800 mg and IM400 mg plus interferon α (IFN). Most patients had their first ADR early with decreasing frequency later on. No new late toxicity was observed. ADR to IM are frequent, but mostly mild and manageable, also with IM 800 mg and IM 400 mg+IFN. The deep molecular response rates indicate that most patients are candidates for IM discontinuation. After 10 years, IM continues to be an excellent initial choice for most patients with CML.

Indexed as

AgedAntineoplastic AgentsBenzamidesDisease-Free SurvivalDisease ProgressionFemaleFollow-Up StudiesFusion Proteins, bcr-ablHumansImatinib MesylateInterferon-alphaLeukemia, Myelogenous, Chronic, BCR-ABL PositiveMaleMiddle AgedPilot ProjectsPiperazinesAntineoplastic AgentsBenzamidesFusion Proteins, bcr-ablImatinib MesylateInterferon-alphaPiperazinesProtein Kinase InhibitorsPyrimidines

Identifiers

PMID25676422
OpenAlexW1998406030

What OpenQuestion holds

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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.