Evidence map›Paper›PMID 26437782›Full record

Trial reportLeukemia2016

Frontline nilotinib in patients with chronic myeloid leukemia in chronic phase: results from the European ENEST1st study.

A Hochhaus, G Rosti, N C P Cross, J L Steegmann, P le Coutre, G Ossenkoppele, L Petrov, T Masszi, A Hellmann, L Griskevicius and 15 more

Abstract readClinical Trial, Phase IIIMulticenter Study
PubMed Full text at PMC 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. Cited by 56 papers.

0numbers the graph read from it
0cells of the map it votes in
56citing 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.

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

56 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

25 authors.

A HochhausAbteilung Hämatologie/Onkologie, Klinik für Innere Medizin II, Universitätsklinikum Jena, Jena, Germany.
G RostiDepartment of Hematology and Oncology, University of Bologna, Bologna, Italy.
N C P CrossFaculty of Medicine, University of Southampton, Southampton, UK.
J L SteegmannHospital Universitario de la Princesa, IIS-IP, Madrid, Spain.
P le CoutreCharité-Universitätsmedizin Berlin, Berlin, Germany.
G OssenkoppeleVU University Medical Center, Amsterdam, The Netherlands.
L PetrovIon Chiricuta Institute of Oncology, Cluj, Romania.
T MassziDepartment of Haematology and Stem Cell Transplantation, St István and St László Hospital, Budapest, Hungary.
A HellmannMedical University of Gdańsk, Gdańsk, Poland.
L GriskeviciusVilnius University Hospital Santariskiu Klinikos, Vilnius University, Vilnius, Lithuania.
W Wiktor-JedrzejczakDepartment of Hematology, Medical University of Warsaw, Warsaw, Poland.
D ReaService d'Hématologie Adulte et INSERM UMR1160, Hôpital Saint-Louis, Paris, France.
D CoriuFundeni Clinical Institute, Bucharest, Romania.
T H BrümmendorfUniversitätsklinikum RWTH Aachen, Aachen, Germany.
K PorkkaDepartment of Hematology, Helsinki University Hospital Comprehensive Cancer Center, Helsinki, Finland.
G SaglioDivision of Internal Medicine & Hematology, University of Turin, Orbassano, Italy.
G GastlInnere Medizin, Medizinische Universität Innsbruck, Innsbruck, Austria.
M C MüllerUniversitätsmedizin Mannheim, University of Heidelberg, Mannheim, Germany.
P SchuldNovartis Pharma AG, Basel, Switzerland.
P Di MatteoNovartis Oncology Region Europe, Origgio, Italy.
A PellegrinoNovartis Oncology Region Europe, Origgio, Italy.
L DezzaniNovartis Oncology Region Europe, Origgio, Italy.ORCID http://orcid.org/0000-0003-2047-2526
F-X MahonLaboratoire Hématopoïèse Leucémique et Cible Thérapeutique, Université Victor Ségalen, Bordeaux, France.
M BaccaraniDepartment of Hematology and Oncology, University of Bologna, Bologna, Italy.
F J GilesNorthwestern Medicine Developmental Therapeutics Institute, Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, IL, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The Evaluating Nilotinib Efficacy and Safety in Clinical Trials as First-Line Treatment (ENEST1st) study included 1089 patients with newly diagnosed chronic myeloid leukemia in chronic phase. The rate of deep molecular response (MR(4) (BCR-ABL1⩽0.01% on the International Scale or undetectable BCR-ABL1 with ⩾10,000 ABL1 transcripts)) at 18 months was evaluated as the primary end point, with molecular responses monitored by the European Treatment and Outcome Study network of standardized laboratories. This analysis was conducted after all patients had completed 24 months of study treatment (80.9% of patients) or discontinued early. In patients with typical BCR-ABL1 transcripts and ⩽3 months of prior imatinib therapy, 38.4% (404/1052) achieved MR(4) at 18 months. Six patients (0.6%) developed accelerated or blastic phase, and 13 (1.2%) died. The safety profile of nilotinib was consistent with that of previous studies, although the frequencies of some nilotinib-associated adverse events were lower (for example, rash, 21.4%). Ischemic cardiovascular events occurred in 6.0% of patients. Routine monitoring of lipid and glucose levels was not mandated in the protocol. These results support the use of frontline nilotinib, particularly when achievement of a deep molecular response (a prerequisite for attempting treatment-free remission in clinical trials) is a treatment goal.

Indexed as

AdolescentAdultAgedAged, 80 and overFemaleFusion Proteins, bcr-ablHumansLeukemia, Myelogenous, Chronic, BCR-ABL PositiveMaleMiddle AgedProtein Kinase InhibitorsProtein-Tyrosine KinasesPyrimidinesBCR-ABL1 fusion protein, humanFusion Proteins, bcr-ablnilotinibProtein Kinase InhibitorsProtein-Tyrosine KinasesPyrimidines

Identifiers

PMID26437782
PMCPMC4705425

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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.