Evidence map›Paper›PMID 23065514›Full record

ArticleHaematologica2013

The quantitative level of T315I mutated BCR-ABL predicts for major molecular response to second-line nilotinib or dasatinib treatment in patients with chronic myeloid leukemia.

Thoralf Lange, Thomas Ernst, Franz X Gruber, Jacqueline Maier, Michael Cross, Martin C Müller, Dietger Niederwieser, Andreas Hochhaus, Markus Pfirrmann

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Haematologica, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00384228 (A Phase I/II Multicenter, Dose-escalation Study of Oral Nilotinib on a Continuous Daily Dosing Schedule in Adult Patients With Imatinib-resistant or Imatinib-intolerant CML, or Relapse/Refractory Ph+ALL), which is not on this map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
2.3field-weighted citation impact, top 12% 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.

NCT00384228 phase1 / phase2completednot on this map

A Phase I/II Multicenter, Dose-escalation Study of Oral Nilotinib on a Continuous Daily Dosing Schedule in Adult Patients With Imatinib-resistant or Imatinib-intolerant CML, or Relapse/Refractory Ph+ALL

TypeinterventionalSponsorNovartis PharmaceuticalsRan2005Enrolled42ConditionsChronic Myelogenous Leukemia, Acute Lymphoblastic Leukemia (Philadelphia Chromosome Positive)ArmsNilotinib
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 20 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 6 institutions in 2 countries.

Thoralf LangeAbteilung für Hämatologie, Onkologie, Hämostaseologie, Universitätsklinikum Leipzig, Leipzig, Germany. langet@medizin.uni-leipzig.de
Thomas Ernst
Franz X Gruber
Jacqueline Maier
Michael Cross
Martin C Müller
Dietger Niederwieser
Andreas Hochhaus
Markus Pfirrmann
University Hospital Leipzig · DEJena University Hospital · DELeipzig University · DEUiT The Arctic University of Norway · NOUniversity Hospital Heidelberg · DEZimmer Biomet (Germany) · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The BCR-ABL T315I mutation causes resistance to imatinib, nilotinib and dasatinib in chronic myeloid leukemia. Forty BCR-ABL positive patients with imatinib resistance were analyzed for T315I mutated clones after six months on nilotinib or dasatinib treatment by quantitative allele-specific ligation polymerase chain reaction with a sensitivity of 0.05%. Ligation polymerase chain reaction revealed 10 patients with more than 10(-5) BCR-ABL(T315I%)/GUS (high levels), none of whom achieved major molecular response after 12 months, and a further 8 patients with 10(-5) or below BCR-ABL(T315I%)/GUS (low levels) who all achieved major molecular response (P<0.001). A second independent group showed molecular response in one of 12 patients with high levels and 5 of 8 patients with low levels (P=0.018). Combining the groups resulted in a sensitivity and specificity of 92.9% and 87.5%, respectively. We conclude that the quantitative level of mutant T315I allele is predictive of major molecular response at 12 months on second-line nilotinib or dasatinib treatment. www.clinicaltrials.gov: CT00109707, NCT00384228, CA180013, CA180005 CA180006.

Indexed as

MutationAdultAgedAllelesAntineoplastic AgentsDasatinibDrug Resistance, NeoplasmFemaleFusion Proteins, bcr-ablHumansLeukemia, Myelogenous, Chronic, BCR-ABL PositiveMaleMiddle AgedPrognosisProtein Kinase InhibitorsPyrimidinesAntineoplastic AgentsDasatinibFusion Proteins, bcr-ablnilotinibProtein Kinase InhibitorsPyrimidinesThiazoles

Identifiers

PMID23065514
PMCPMC3640114
OpenAlexW1996264047

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.