Evidence map›Paper›PMID 25082346›Full record

Trial reportEuropean journal of haematology2015

Dasatinib induces fast and deep responses in newly diagnosed chronic myeloid leukaemia patients in chronic phase: clinical results from a randomised phase-2 study (NordCML006).

Henrik Hjorth-Hansen, Leif Stenke, Stina Söderlund, Arta Dreimane, Hans Ehrencrona, Tobias Gedde-Dahl, Bjørn Tore Gjertsen, Martin Höglund, Perttu Koskenvesa, Kourosh Lotfi and 11 more

Registry-linked trialAbstract readClinical Trial, Phase IIComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in European journal of haematology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00852566 (An Open-Label, Randomized, Multicenter Phase II Trial Comparing the Depletion of Malignant Stem Cells With Dasatinib vs. Imatinib in Patients With Newly Diagnosed Chronic Phase Chronic Myeloid), which is not on this map. Cited by 40 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
40citing 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.

NCT00852566 phase2completednot on this map

An Open-Label, Randomized, Multicenter Phase II Trial Comparing the Depletion of Malignant Stem Cells With Dasatinib vs. Imatinib in Patients With Newly Diagnosed Chronic Phase Chronic Myeloid

TypeinterventionalSponsorNorwegian University of Science and TechnologyRan2009 to 2015Enrolled46ConditionsChronic Myeloid LeukemiaArmsImatinib, Dasatinib
3 · Its place in the literature

Who cites it

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

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  10. Final 5-Year Study Results of DASISION: The Dasatinib Versus Imatinib Study in Treatment-Naïve Chronic Myeloid Leukemia Patients Trial.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2016
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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

21 authors.

Henrik Hjorth-HansenDepartment of Hematology, St Olavs Hospital, Trondheim, Norway; Department of Cancer Research and Molecular Medicine, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.
Leif Stenke
Stina Söderlund
Arta Dreimane
Hans Ehrencrona
Tobias Gedde-Dahl
Bjørn Tore Gjertsen
Martin Höglund
Perttu Koskenvesa
Kourosh Lotfi
Waleed Majeed
Berit Markevärn
Lotta Ohm
Ulla Olsson-Strömberg
Kari Remes
Merja Suominen
Bengt Simonsson
Kimmo Porkka
Satu Mustjoki
Johan Richter
Nordic CML Study Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

We randomised 46 newly diagnosed patients with chronic myeloid leukaemia (median age 56) to receive dasatinib 100 mg QD or imatinib 400 mg QD and report outcome as an intention-to-treat analysis with 36 months follow-up. Early cytogenetic and molecular responses were superior in the dasatinib group, with a tendency that imatinib patients caught up with time. For instance, MR(3.0) was reached at 3 months in 36% vs. 8% (P = 0.02), at 12 months in 81% vs. 46% (P = 0.02) and at 18 months in 73% vs. 65% (n.s.) of the patients in the two groups. In contrast, MR(4.5) was consistently superior in the dasatinib group at all time points from 6 months onwards, reaching 61% vs. 21% (P < 0.05) at 36 months. Sixty-four vs. 71% of the patients in the dasatinib and imatinib arms, respectively, remained on assigned drug. Dasatinib dose was frequently reduced, but with maintained excellent effect. One imatinib patient progressed to blastic phase, but no CML-related deaths occurred. In conclusion, our data compare favourably with those of the dasatinib registration study, DASISION. The fast and deep molecular responses induced by dasatinib compared with imatinib may be exploited to increase the proportion of patients who can achieve a treatment-free remission after treatment discontinuation.

Indexed as

AdultAgedAntineoplastic AgentsBenzamidesDasatinibDrug Administration ScheduleFemaleFollow-Up StudiesFusion Proteins, bcr-ablGene ExpressionHumansHydroxyureaImatinib MesylateLeukemia, Myelogenous, Chronic, BCR-ABL PositiveMaleMiddle AgedAntineoplastic AgentsBCR-ABL1 fusion protein, humanBenzamidesDasatinibFusion Proteins, bcr-ablHydroxyureaImatinib MesylatePiperazinesProtein Kinase InhibitorsPyrimidinesThiazolesdasatinibdeep responseimatinibrandomized controlled trialtoxicity

Identifiers

PMID25082346
PMCPMC4365700

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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.