Evidence map›Paper›PMID 20679528›Full record

Trial reportBlood2010

Long-term prognostic significance of early molecular response to imatinib in newly diagnosed chronic myeloid leukemia: an analysis from the International Randomized Study of Interferon and STI571 (IRIS).

Timothy P Hughes, Andreas Hochhaus, Susan Branford, Martin C Müller, Jaspal S Kaeda, Letizia Foroni, Brian J Druker, François Guilhot, Richard A Larson, Stephen G O'Brien and 7 more

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Blood, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00006343 (A Phase III Study of STI571 Versus Interferon-a), which is not on this map. Cited by 188 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
188citing papers in PubMed, 1 pooled it
–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.

NCT00006343 phase3completednot on this map

A Phase III Study of STI571 Versus Interferon-a (IFN-a) Combined With Cytarabine (Ara-C) in Patients With Newly Diagnosed Previously Untreated Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)

TypeinterventionalSponsorNovartisRan2000 to 2007ConditionsLeukemiaArmsrecombinant interferon alfa, cytarabine, imatinib mesylate
3 · Its place in the literature

Who cites it

188 citing papers in PubMed, 1 synthesis or guideline pooled it.

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  14. Final 5-Year Study Results of DASISION: The Dasatinib Versus Imatinib Study in Treatment-Naïve Chronic Myeloid Leukemia Patients Trial.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2016
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128 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

17 authors.

Timothy P HughesDepartment of Haematology, SA Pathology, Royal Adelaide Hospital, Adelaide, Australia. timothy.hughes@health.sa.gov.au
Andreas Hochhaus
Susan Branford
Martin C Müller
Jaspal S Kaeda
Letizia Foroni
Brian J Druker
François Guilhot
Richard A Larson
Stephen G O'Brien
Marc S Rudoltz
Manisha Mone
Elisabeth Wehrle
Vijay Modur
John M Goldman
Jerald P Radich
IRIS investigators

Funding

VIRUS-MEDIATED MYELOSUPPRESSIONP01CA018029 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Geoffrey Roger HILL · 1985 to 2026
$128.4M
NCI NIH HHS CA 18 029NCI NIH HHS P01 CA018029
6 · The paper itself

Abstract

This study examines the prognostic significance of early molecular response using an expanded dataset in chronic myeloid leukemia patients enrolled in the International Randomized Study of Interferon and STI571 (IRIS). Serial molecular studies demonstrate decreases in BCR-ABL transcripts over time. Analyses of event-free survival (EFS) and time to progression to accelerated phase/blast crisis (AP/BC) at 7 years were based on molecular responses using the international scale (IS) at 6-, 12-, and 18-month landmarks. Patients with BCR-ABL transcripts > 10% at 6 months and > 1% at 12 months had inferior EFS and higher rate of progression to AP/BC compared with all other molecular response groups. Conversely, patients who achieved major molecular response [MMR: BCR-ABL (IS) ≤ 0.1%] by 18 months enjoyed remarkably durable responses, with no progression to AP/BC and 95% EFS at 7 years. The probability of loss of complete cytogenetic response by 7 years was only 3% for patients in MMR at 18 months versus 26% for patients with complete cytogenetic response but not MMR (P < .001). This study shows a strong association between the degree to which BCR-ABL transcript numbers are reduced by therapy and long-term clinical outcome, supporting the use of time-dependent molecular measures to determine optimal response to therapy. This study is registered at www.clinicaltrials.gov as NCT00006343.

Indexed as

AdolescentAdultAgedAntineoplastic AgentsBenzamidesDisease-Free SurvivalFemaleGenes, ablHumansImatinib MesylateInterferonsLeukemia, Myelogenous, Chronic, BCR-ABL PositiveMaleMiddle AgedPiperazinesPrognosisAntineoplastic AgentsBenzamidesImatinib MesylateInterferonsPiperazinesPyrimidines

Identifiers

PMID20679528
PMCPMC3266053

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.