Evidence map›Paper›PMID 22763385›Full record

Trial reportLeukemia2013

Nilotinib in imatinib-resistant or imatinib-intolerant patients with chronic myeloid leukemia in chronic phase: 48-month follow-up results of a phase II study.

F J Giles, P D le Coutre, J Pinilla-Ibarz, R A Larson, N Gattermann, O G Ottmann, A Hochhaus, J P Radich, G Saglio, T P Hughes and 8 more

Abstract readClinical Trial, Phase IIComparative StudyMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Leukemia, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 100 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
100citing papers in PubMed, 3 pooled it
13.1field-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

100 citing papers in PubMed, 3 syntheses or guidelines pooled it, 246 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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  20. Observational

40 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

18 authors at 13 institutions in 7 countries.

F J GilesHRB Clinical Research Facilities, National University of Ireland Galway and Trinity College, Dublin, Ireland. frankgiles@aol.com
P D le Coutre
J Pinilla-Ibarz
R A Larson
N Gattermann
O G Ottmann
A Hochhaus
J P Radich
G Saglio
T P Hughes
G Martinelli
D-W Kim
S Novick
K Gillis
X Fan
J Cortes
M Baccarani
H M Kantarjian
Novartis (Switzerland) · CHThe University of Texas MD Anderson Cancer Center · USUniversity of Bologna · ITFred Hutch Cancer Center · USFriedrich Schiller University Jena · DEGoethe University Frankfurt · DEHeinrich Heine University Düsseldorf · DEHumboldt-Universität zu Berlin · DENational University of Ireland · IESeoul St. Mary's Hospital · KRSouth Australia Pathology · AUUniversity of Chicago · USUniversity of South Florida · US

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

Nilotinib (Tasigna) is a BCR-ABL1 tyrosine kinase inhibitor approved for the treatment of patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (CML-CP) who are newly diagnosed or intolerant of or resistant to imatinib. The 48-month follow-up data for patients with CML-CP treated with nilotinib after imatinib resistance or intolerance on an international phase II study were analyzed. Overall, 59% of patients achieved major cytogenetic response; 45% achieved complete cytogenetic response while on study. The estimated rate of overall survival (OS) and progression-free survival (PFS) at 48 months was 78% and 57%, respectively. Deeper levels of molecular responses at 3 and 6 months were highly positively correlated with long-term outcomes, including PFS and OS at 48 months. Of the 321 patients initially enrolled in the study, 98 (31%) were treated for at least 48 months. Discontinuations were primarily due to disease progression (30%) or adverse events (21%). Nilotinib is safe and effective for long-term use in responding patients with CML-CP who are intolerant of or resistant to imatinib. Further significant improvements in therapy are required for patients who are resistant or intolerant to imatinib.

Indexed as

Salvage TherapyAdolescentAdultAgedAged, 80 and overBenzamidesDrug Resistance, NeoplasmFemaleFollow-Up StudiesHumansImatinib MesylateInternational AgenciesLeukemia, Myeloid, Chronic-PhaseMaleMaximum Tolerated DoseMiddle AgedBenzamidesImatinib MesylatenilotinibPiperazinesProtein Kinase InhibitorsPyrimidines

Identifiers

PMID22763385
OpenAlexW2076720738

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.