Evidence map›Paper›PMID 27133821›Full record

Trial reportLeukemia2016

Safety and efficacy of the combination of pegylated interferon-α2b and dasatinib in newly diagnosed chronic-phase chronic myeloid leukemia patients.

H Hjorth-Hansen, J Stentoft, J Richter, P Koskenvesa, M Höglund, A Dreimane, K Porkka, T Gedde-Dahl, B T Gjertsen, F X Gruber and 10 more

Registry-linked trialAbstract readClinical Trial, Phase II
PubMed Publisher
In one paragraph

Trial report in Leukemia, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01725204 (A Safety and Efficacy Study of Adding Low Dose Pegylated IFN-alpha 2B to Standard Dose Dasatinib in Patients With Newly Diagnosed Chronic Phase Myeloid Leukemia), which is not on this map. Cited by 33 papers.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed
–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.

NCT01725204 phase2completednot on this map

A Safety and Efficacy Study of Adding Low Dose Pegylated IFN-alpha 2B to Standard Dose Dasatinib in Patients With Newly Diagnosed Chronic Phase Myeloid Leukemia

TypeinterventionalSponsorNorwegian University of Science and TechnologyRan2012 to 2016Enrolled40ConditionsLeukemia, Myeloid, Chronic-PhaseArmsDasatinib + PegIFN
3 · Its place in the literature

Who cites it

33 citing papers in PubMed.

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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

20 authors.

H Hjorth-HansenDepartment of Hematology, St Olavs Hospital, Trondheim, Norway.
J StentoftDepartment of Hematology, Aarhus University Hospital, Aarhus, Denmark.
J RichterDepartment of Hematology and Vascular Disorders, Skåne University Hospital, Lund, Sweden.
P KoskenvesaHematology Research Unit Helsinki, University of Helsinki and Department of Hematology, Helsinki University Hospital Comprehensive Cancer Center, Helsinki, Finland.
M HöglundDepartment of Hematology, Uppsala University Hospital, Uppsala, Sweden.
A DreimaneDepartment of Medical and Health Sciences, Linköping University, Department of Hematology, County Council of Östergötland, Linköping, Sweden.
K PorkkaHematology Research Unit Helsinki, University of Helsinki and Department of Hematology, Helsinki University Hospital Comprehensive Cancer Center, Helsinki, Finland.
T Gedde-DahlDepartment of Hematology, Oslo University Hospital, Rikshospitalet, Oslo, Norway.
B T GjertsenDepartment of Internal Medicine, Hematology Section, Haukeland University Hospital and Department of Clinical Science, University of Bergen, Bergen, Norway.
F X GruberDepartment of Hematology, University Hospital of North Norway, Tromsø, Norway.
L StenkeDepartment of Hematology, Karolinska University Hospital and Karolinska Institutet, Stockholm, Sweden.
K M ErikssonDepartment of Internal Medicine, Sunderbysjukhuset, Luleå, Sweden.
B MarkevärnDepartment of Hematology, Umeå University Hospital, Umeå, Sweden.
A LübkingHematology Research Unit Helsinki, University of Helsinki and Department of Hematology, Helsinki University Hospital Comprehensive Cancer Center, Helsinki, Finland.
H VestergaardDepartment of Hematology, Odense University Hospital, Odense, Denmark.
L UdbyDepartment of Hematology, Roskilde Hospital, Roskilde, Denmark.
O W BjerrumDepartment of Hematology, Rigshospitalet, University Hospital of Copenhagen, Copenhagen, Denmark.
I PerssonDepartment of Statistics, Uppsala University, Uppsala, Sweden.
S MustjokiHematology Research Unit Helsinki, University of Helsinki and Department of Hematology, Helsinki University Hospital Comprehensive Cancer Center, Helsinki, Finland.
U Olsson-StrömbergDepartment of Hematology, Uppsala University Hospital, Uppsala, Sweden.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Dasatinib (DAS) and interferon-α have antileukemic and immunostimulatory effects and induce deep responses in chronic myeloid leukemia (CML). We assigned 40 newly diagnosed chronic-phase CML patients to receive DAS 100 mg o.d. followed by addition of pegylated interferon-α2b (PegIFN) after 3 months (M3). The starting dose of PegIFN was 15 μg/week and it increased to 25 μg/week at M6 until M15. The combination was well tolerated with manageable toxicity. Of the patients, 84% remained on PegIFN at M12 and 91% (DAS) and 73% (PegIFN) of assigned dose was given. Only one patient had a pleural effusion during first year, and three more during the second year. After introduction of PegIFN we observed a steep increase in response rates. Major molecular response was achieved in 10%, 57%, 84% and 89% of patients at M3, M6, M12 and M18, respectively. At M12, MR(4) was achieved by 46% and MR(4.5) by 27% of patients. No patients progressed to advanced phase. In conclusion, the combination treatment appeared safe with very promising efficacy. A randomized comparison of DAS±PegIFN is warranted.

Indexed as

AdolescentAdultAgedAntineoplastic Combined Chemotherapy ProtocolsDasatinibFemaleHumansInterferon-alphaInterferon alpha-2Leukemia, Myeloid, Chronic-PhaseMaleMiddle AgedPleural EffusionPolyethylene GlycolsRecombinant ProteinsRemission InductionDasatinibInterferon-alphaInterferon alpha-2peginterferon alfa-2bPolyethylene GlycolsRecombinant Proteins

Identifiers

PMID27133821

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.