Evidence map›Paper›PMID 22160483›Full record

Trial reportBlood2012

Dasatinib or imatinib in newly diagnosed chronic-phase chronic myeloid leukemia: 2-year follow-up from a randomized phase 3 trial (DASISION).

Hagop M Kantarjian, Neil P Shah, Jorge E Cortes, Michele Baccarani, Mohan B Agarwal, María Soledad Undurraga, Jianxiang Wang, Juan Julio Kassack Ipiña, Dong-Wook Kim, Michinori Ogura and 10 more

Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Blood, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00481247 (An Open-Label, Randomized, Multicenter Phase III Trial of Dasatinib), which is not on this map. Cited by 248 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
248citing papers in PubMed, 4 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.

NCT00481247 phase3completednot on this map

An Open-Label, Randomized, Multicenter Phase III Trial of Dasatinib (SPRYCEL®) vs. Standard Dose Imatinib (400 mg) in the Treatment of Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive Chronic Myeloid Leukemia

TypeinterventionalSponsorBristol-Myers SquibbRan2007 to 2015Enrolled547ConditionsMyeloid Leukemia, ChronicArmsDasatinib, Imatinib
3 · Its place in the literature

Who cites it

248 citing papers in PubMed, 4 syntheses or guidelines pooled it.

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  10. Dasatinib in Pediatric Patients With Chronic Myeloid Leukemia in Chronic Phase: Results From a Phase II Trial.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2018
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  15. 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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188 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

20 authors.

Hagop M KantarjianThe University of Texas M. D. Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX 77030, USA. hkantarj@mdanderson.org
Neil P Shah
Jorge E Cortes
Michele Baccarani
Mohan B Agarwal
María Soledad Undurraga
Jianxiang Wang
Juan Julio Kassack Ipiña
Dong-Wook Kim
Michinori Ogura
Carolina Pavlovsky
Christian Junghanss
Jorge H Milone
Franck E Nicolini
Tadeusz Robak
Jan Van Droogenbroeck
Edo Vellenga
M Brigid Bradley-Garelik
Chao Zhu
Andreas Hochhaus

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

Dasatinib is a highly potent BCR-ABL inhibitor with established efficacy and safety in imatinib-resistant/-intolerant patients with chronic myeloid leukemia (CML). In the phase 3 DASISION trial, patients with newly diagnosed chronic-phase (CP) CML were randomized to receive dasatinib 100 mg (n = 259) or imatinib 400 mg (n = 260) once daily. Primary data showed superior efficacy for dasatinib compared with imatinib after 12 months, including significantly higher rates of complete cytogenetic response (CCyR), confirmed CCyR (primary end point), and major molecular response (MMR). Here, 24-month data are presented. Cumulative response rates by 24 months in dasatinib and imatinib arms were: CCyR in 86% versus 82%, MMR in 64% versus 46%, and BCR-ABL reduction to ≤ 0.0032% (4.5-log reduction) in 17% versus 8%. Transformation to accelerated-/ blast-phase CML on study occurred in 2.3% with dasatinib versus 5.0% with imatinib. BCR-ABL mutations, assessed after discontinuation, were detected in 10 patients in each arm. In safety analyses, fluid retention, superficial edema, myalgia, vomiting, and rash were less frequent with dasatinib compared with imatinib, whereas pleural effusion and grade 3/4 thrombocytopenia were more frequent with dasatinib. Overall, dasatinib continues to show faster and deeper responses compared with imatinib, supporting first-line use of dasatinib in patients with newly diagnosed CML-CP. This study was registered at ClinicalTrials.gov: NCT00481247.

Indexed as

Age of OnsetAlgorithmsAntineoplastic AgentsBenzamidesCytogenetic AnalysisDasatinibDNA Mutational AnalysisFollow-Up StudiesFusion Proteins, bcr-ablHumansImatinib MesylateLeukemia, Myeloid, Chronic-PhaseMiddle AgedNeoadjuvant TherapyPiperazinesPyrimidinesAntineoplastic AgentsBenzamidesDasatinibFusion Proteins, bcr-ablImatinib MesylatePiperazinesPyrimidinesThiazoles

Identifiers

PMID22160483
PMCPMC4916556

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.