Evidence map›Paper›PMID 22699418›Full record

Trial reportLeukemia2012

Nilotinib vs imatinib in patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase: ENESTnd 3-year follow-up.

R A Larson, A Hochhaus, T P Hughes, R E Clark, G Etienne, D-W Kim, I W Flinn, M Kurokawa, B Moiraghi, R Yu and 4 more

Registry-linked trialAbstract readComparative StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Leukemia, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03117816 (Efficacy and Safety of Pegylated Proline Interferon Alpha 2b), which is not on this map. Cited by 172 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
172citing papers in PubMed, 3 pooled it
37.0field-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.

NCT03117816 phase3completednot on this mapstarted 2017, after this paper: background citation

Efficacy and Safety of Pegylated Proline Interferon Alpha 2b (AOP2014) in Maintaining Deep Molecular Remissions in Patients With Chronic Myeloid Leukemia (CML) Who Discontinue ABL-Kinase Inhibitor Therapy - a Randomized Phase III, Multicenter Trial With Post-study Follow-up

TypeinterventionalSponsorPhilipps University MarburgRan2017 to 2022Enrolled214ConditionsChronic Myeloid Leukemia in RemissionArmsAOP2014 / Pegylated-Proline-interferon alpha-2b, Surveillance
3 · Its place in the literature

Who cites it

172 citing papers in PubMed, 3 syntheses or guidelines pooled it, 437 citations in OpenAlex.

  1. [Guideline for the diagnosis and treatment of chronic myeloid leukemia in China (2025)].Zhonghua xue ye xue za zhi = Zhonghua xueyexue zazhi · 2025
    Guideline
  2. Pooled it
  3. Chronic Myelogenous Leukemia, Version 1.2014.Journal of the National Comprehensive Cancer Network : JNCCN · 2013
    Guideline
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112 more citing papers are in PubMed but not listed here.

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

14 authors at 12 institutions in 10 countries.

R A LarsonUniversity of Chicago, Chicago, IL, USA. rlarson@medicine.bsd.uchicago.edu
A Hochhaus
T P Hughes
R E Clark
G Etienne
D-W Kim
I W Flinn
M Kurokawa
B Moiraghi
R Yu
R E Blakesley
N J Gallagher
G Saglio
H M Kantarjian
Novartis (Switzerland) · CHCatholic University of Korea · KRFriedrich Schiller University Jena · DEHospital Ramos Mejía · ARInstitut Bergonié · FRRoyal Adelaide Hospital · AURoyal Liverpool and Broadgreen University Hospital NHS Trust · GBSarah Cannon Research Institute · GBThe University of Texas MD Anderson Cancer Center · USThe University of Tokyo · JPUniversity of Chicago · USUniversity of Turin · IT

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
6 · The paper itself

Abstract

Evaluating Nilotinib Efficacy and Safety in Clinical Trials Newly Diagnosed Patients compares nilotinib and imatinib in patients with newly diagnosed chronic myeloid leukemia in chronic phase (CML-CP). With a minimum follow-up of 3 years, major molecular response, molecular response of BCR-ABL≤ 0.01% expressed on the international scale (BCR-ABL(IS); MR(4)) and BCR-ABL(IS)≤ 0.0032% (MR(4.5)) rates were significantly higher with nilotinib compared with imatinib, and differences in the depth of molecular response between nilotinib and imatinib have increased over time. No new progressions occurred on treatment since the 2-year analysis. Nilotinib was associated with a significantly lower probability of progression to accelerated phase/blast crisis vs imatinib (two (0.7%) progressions on nilotinib 300 mg twice daily, three (1.1%) on nilotinib 400 mg twice daily and 12 (4.2%) on imatinib). When considering progressions occurring after study treatment discontinuation, the advantage of nilotinib over imatinib in preventing progression remained significant (nine (3.2%) progressions on nilotinib 300 mg twice daily, six (2.1%) on nilotinib 400 mg twice daily and 19 (6.7%) on imatinib). Both nilotinib and imatinib were well tolerated, with minimal changes in safety over time. Nilotinib continues to demonstrate superior efficacy in all key response and outcome parameters compared with imatinib for the treatment of patients with newly diagnosed CML-CP.

Indexed as

BenzamidesFollow-Up StudiesHumansImatinib MesylateLeukemia, Myelogenous, Chronic, BCR-ABL PositivePiperazinesProtein Kinase InhibitorsPyrimidinesBenzamidesImatinib MesylatenilotinibPiperazinesProtein Kinase InhibitorsPyrimidines

Identifiers

PMID22699418
OpenAlexW2072834954

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.