Evidence map›Paper›PMID 27217448›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2016

Final 5-Year Study Results of DASISION: The Dasatinib Versus Imatinib Study in Treatment-Naïve Chronic Myeloid Leukemia Patients Trial.

Jorge E Cortes, Giuseppe Saglio, Hagop M Kantarjian, Michele Baccarani, Jiří Mayer, Concepción Boqué, Neil P Shah, Charles Chuah, Luis Casanova, Brigid Bradley-Garelik and 2 more

Registry-linked trialAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04150471 (An Open Label, Observational Clinical Study to Assess Long-term Feasibility of Reduced Dose Dasatinib in Chronic Phase Chronic Myeloid Leukemia Patients Who Have Any Grade of Adverse Events and Early Molecular Response Within 3 Months of Frontline Dasatinib Therapy), which is not on this map. Cited by 514 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
514citing papers in PubMed, 4 pooled it
68.0field-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.

NCT04150471 unknown statusnot on this mapstarted 2018, after this paper: background citation

An Open Label, Observational Clinical Study to Assess Long-term Feasibility of Reduced Dose Dasatinib in Chronic Phase Chronic Myeloid Leukemia Patients Who Have Any Grade of Adverse Events and Early Molecular Response Within 3 Months of Frontline Dasatinib Therapy

TypeobservationalSponsorSeoul St. Mary's HospitalRan2018 to 2023Enrolled79ConditionsChronic Myelocytic LeukemiaArmsRQ-PCR(Real-time Quantitative Polymerase chain reaction) RNA Analysis
3 · Its place in the literature

Who cites it

514 citing papers in PubMed, 4 syntheses or guidelines pooled it, 927 citations in OpenAlex.

  1. Pooled it
  2. [Guideline for the diagnosis and treatment of chronic myeloid leukemia in China (2025)].Zhonghua xue ye xue za zhi = Zhonghua xueyexue zazhi · 2025
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454 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 1 institution in 1 country.

Jorge E CortesJorge E. Cortes and Hagop M. Kantarjian The University of Texas MD Anderson Cancer Center, Houston, TX; Neil P. Shah, University of California San Francisco School of Medicine, San Francisco, CA; Brigid Bradley-Garelik and George Manos, Bristol-Myers Squibb, Princeton, NJ; Giuseppe Saglio, University of Turin, Turin; Michele Baccarani, S. Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy; Jiří Mayer, University Hospital Brno and Central European Institute of Technology, Masaryk University, Brno, Czech Republic; Concepción Boqué, Institut Català d'Oncologia, Hospital Duran i Reynals, L'Hospitalet, Barcelona, Spain; Charles Chuah, Singapore General Hospital, Duke-National University of Singapore Medical School, Singapore; Luis Casanova, Instituto Nacional de Enfermedades Neoplásicas, Lima, Perú;and Andreas Hochhaus, Universitätsklinikum Jena, Jena, Germany. jcortes@mdanderson.org.
Giuseppe SaglioJorge E. Cortes and Hagop M. Kantarjian The University of Texas MD Anderson Cancer Center, Houston, TX; Neil P. Shah, University of California San Francisco School of Medicine, San Francisco, CA; Brigid Bradley-Garelik and George Manos, Bristol-Myers Squibb, Princeton, NJ; Giuseppe Saglio, University of Turin, Turin; Michele Baccarani, S. Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy; Jiří Mayer, University Hospital Brno and Central European Institute of Technology, Masaryk University, Brno, Czech Republic; Concepción Boqué, Institut Català d'Oncologia, Hospital Duran i Reynals, L'Hospitalet, Barcelona, Spain; Charles Chuah, Singapore General Hospital, Duke-National University of Singapore Medical School, Singapore; Luis Casanova, Instituto Nacional de Enfermedades Neoplásicas, Lima, Perú;and Andreas Hochhaus, Universitätsklinikum Jena, Jena, Germany.
Hagop M KantarjianJorge E. Cortes and Hagop M. Kantarjian The University of Texas MD Anderson Cancer Center, Houston, TX; Neil P. Shah, University of California San Francisco School of Medicine, San Francisco, CA; Brigid Bradley-Garelik and George Manos, Bristol-Myers Squibb, Princeton, NJ; Giuseppe Saglio, University of Turin, Turin; Michele Baccarani, S. Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy; Jiří Mayer, University Hospital Brno and Central European Institute of Technology, Masaryk University, Brno, Czech Republic; Concepción Boqué, Institut Català d'Oncologia, Hospital Duran i Reynals, L'Hospitalet, Barcelona, Spain; Charles Chuah, Singapore General Hospital, Duke-National University of Singapore Medical School, Singapore; Luis Casanova, Instituto Nacional de Enfermedades Neoplásicas, Lima, Perú;and Andreas Hochhaus, Universitätsklinikum Jena, Jena, Germany.
Michele BaccaraniJorge E. Cortes and Hagop M. Kantarjian The University of Texas MD Anderson Cancer Center, Houston, TX; Neil P. Shah, University of California San Francisco School of Medicine, San Francisco, CA; Brigid Bradley-Garelik and George Manos, Bristol-Myers Squibb, Princeton, NJ; Giuseppe Saglio, University of Turin, Turin; Michele Baccarani, S. Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy; Jiří Mayer, University Hospital Brno and Central European Institute of Technology, Masaryk University, Brno, Czech Republic; Concepción Boqué, Institut Català d'Oncologia, Hospital Duran i Reynals, L'Hospitalet, Barcelona, Spain; Charles Chuah, Singapore General Hospital, Duke-National University of Singapore Medical School, Singapore; Luis Casanova, Instituto Nacional de Enfermedades Neoplásicas, Lima, Perú;and Andreas Hochhaus, Universitätsklinikum Jena, Jena, Germany.
Jiří MayerJorge E. Cortes and Hagop M. Kantarjian The University of Texas MD Anderson Cancer Center, Houston, TX; Neil P. Shah, University of California San Francisco School of Medicine, San Francisco, CA; Brigid Bradley-Garelik and George Manos, Bristol-Myers Squibb, Princeton, NJ; Giuseppe Saglio, University of Turin, Turin; Michele Baccarani, S. Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy; Jiří Mayer, University Hospital Brno and Central European Institute of Technology, Masaryk University, Brno, Czech Republic; Concepción Boqué, Institut Català d'Oncologia, Hospital Duran i Reynals, L'Hospitalet, Barcelona, Spain; Charles Chuah, Singapore General Hospital, Duke-National University of Singapore Medical School, Singapore; Luis Casanova, Instituto Nacional de Enfermedades Neoplásicas, Lima, Perú;and Andreas Hochhaus, Universitätsklinikum Jena, Jena, Germany.
Concepción BoquéJorge E. Cortes and Hagop M. Kantarjian The University of Texas MD Anderson Cancer Center, Houston, TX; Neil P. Shah, University of California San Francisco School of Medicine, San Francisco, CA; Brigid Bradley-Garelik and George Manos, Bristol-Myers Squibb, Princeton, NJ; Giuseppe Saglio, University of Turin, Turin; Michele Baccarani, S. Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy; Jiří Mayer, University Hospital Brno and Central European Institute of Technology, Masaryk University, Brno, Czech Republic; Concepción Boqué, Institut Català d'Oncologia, Hospital Duran i Reynals, L'Hospitalet, Barcelona, Spain; Charles Chuah, Singapore General Hospital, Duke-National University of Singapore Medical School, Singapore; Luis Casanova, Instituto Nacional de Enfermedades Neoplásicas, Lima, Perú;and Andreas Hochhaus, Universitätsklinikum Jena, Jena, Germany.
Neil P ShahJorge E. Cortes and Hagop M. Kantarjian The University of Texas MD Anderson Cancer Center, Houston, TX; Neil P. Shah, University of California San Francisco School of Medicine, San Francisco, CA; Brigid Bradley-Garelik and George Manos, Bristol-Myers Squibb, Princeton, NJ; Giuseppe Saglio, University of Turin, Turin; Michele Baccarani, S. Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy; Jiří Mayer, University Hospital Brno and Central European Institute of Technology, Masaryk University, Brno, Czech Republic; Concepción Boqué, Institut Català d'Oncologia, Hospital Duran i Reynals, L'Hospitalet, Barcelona, Spain; Charles Chuah, Singapore General Hospital, Duke-National University of Singapore Medical School, Singapore; Luis Casanova, Instituto Nacional de Enfermedades Neoplásicas, Lima, Perú;and Andreas Hochhaus, Universitätsklinikum Jena, Jena, Germany.
Charles ChuahJorge E. Cortes and Hagop M. Kantarjian The University of Texas MD Anderson Cancer Center, Houston, TX; Neil P. Shah, University of California San Francisco School of Medicine, San Francisco, CA; Brigid Bradley-Garelik and George Manos, Bristol-Myers Squibb, Princeton, NJ; Giuseppe Saglio, University of Turin, Turin; Michele Baccarani, S. Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy; Jiří Mayer, University Hospital Brno and Central European Institute of Technology, Masaryk University, Brno, Czech Republic; Concepción Boqué, Institut Català d'Oncologia, Hospital Duran i Reynals, L'Hospitalet, Barcelona, Spain; Charles Chuah, Singapore General Hospital, Duke-National University of Singapore Medical School, Singapore; Luis Casanova, Instituto Nacional de Enfermedades Neoplásicas, Lima, Perú;and Andreas Hochhaus, Universitätsklinikum Jena, Jena, Germany.
Luis CasanovaJorge E. Cortes and Hagop M. Kantarjian The University of Texas MD Anderson Cancer Center, Houston, TX; Neil P. Shah, University of California San Francisco School of Medicine, San Francisco, CA; Brigid Bradley-Garelik and George Manos, Bristol-Myers Squibb, Princeton, NJ; Giuseppe Saglio, University of Turin, Turin; Michele Baccarani, S. Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy; Jiří Mayer, University Hospital Brno and Central European Institute of Technology, Masaryk University, Brno, Czech Republic; Concepción Boqué, Institut Català d'Oncologia, Hospital Duran i Reynals, L'Hospitalet, Barcelona, Spain; Charles Chuah, Singapore General Hospital, Duke-National University of Singapore Medical School, Singapore; Luis Casanova, Instituto Nacional de Enfermedades Neoplásicas, Lima, Perú;and Andreas Hochhaus, Universitätsklinikum Jena, Jena, Germany.
Brigid Bradley-GarelikJorge E. Cortes and Hagop M. Kantarjian The University of Texas MD Anderson Cancer Center, Houston, TX; Neil P. Shah, University of California San Francisco School of Medicine, San Francisco, CA; Brigid Bradley-Garelik and George Manos, Bristol-Myers Squibb, Princeton, NJ; Giuseppe Saglio, University of Turin, Turin; Michele Baccarani, S. Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy; Jiří Mayer, University Hospital Brno and Central European Institute of Technology, Masaryk University, Brno, Czech Republic; Concepción Boqué, Institut Català d'Oncologia, Hospital Duran i Reynals, L'Hospitalet, Barcelona, Spain; Charles Chuah, Singapore General Hospital, Duke-National University of Singapore Medical School, Singapore; Luis Casanova, Instituto Nacional de Enfermedades Neoplásicas, Lima, Perú;and Andreas Hochhaus, Universitätsklinikum Jena, Jena, Germany.
George ManosJorge E. Cortes and Hagop M. Kantarjian The University of Texas MD Anderson Cancer Center, Houston, TX; Neil P. Shah, University of California San Francisco School of Medicine, San Francisco, CA; Brigid Bradley-Garelik and George Manos, Bristol-Myers Squibb, Princeton, NJ; Giuseppe Saglio, University of Turin, Turin; Michele Baccarani, S. Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy; Jiří Mayer, University Hospital Brno and Central European Institute of Technology, Masaryk University, Brno, Czech Republic; Concepción Boqué, Institut Català d'Oncologia, Hospital Duran i Reynals, L'Hospitalet, Barcelona, Spain; Charles Chuah, Singapore General Hospital, Duke-National University of Singapore Medical School, Singapore; Luis Casanova, Instituto Nacional de Enfermedades Neoplásicas, Lima, Perú;and Andreas Hochhaus, Universitätsklinikum Jena, Jena, Germany.
Andreas HochhausJorge E. Cortes and Hagop M. Kantarjian The University of Texas MD Anderson Cancer Center, Houston, TX; Neil P. Shah, University of California San Francisco School of Medicine, San Francisco, CA; Brigid Bradley-Garelik and George Manos, Bristol-Myers Squibb, Princeton, NJ; Giuseppe Saglio, University of Turin, Turin; Michele Baccarani, S. Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy; Jiří Mayer, University Hospital Brno and Central European Institute of Technology, Masaryk University, Brno, Czech Republic; Concepción Boqué, Institut Català d'Oncologia, Hospital Duran i Reynals, L'Hospitalet, Barcelona, Spain; Charles Chuah, Singapore General Hospital, Duke-National University of Singapore Medical School, Singapore; Luis Casanova, Instituto Nacional de Enfermedades Neoplásicas, Lima, Perú;and Andreas Hochhaus, Universitätsklinikum Jena, Jena, Germany.
IRCCS Azienda Ospedliero-Universitaria di Bologna Policlinico di Sant'Orsola · IT

Funding

TOLERANCE INDUCTION BY MEGADOSE STEM CELL TRANSPLANTS IN CML--GVHD AND GVLP01CA049639 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI THALL, PETER F · 1990 to 2014
$41.8M
NCI NIH HHS P01 CA049639
6 · The paper itself

Abstract

purposeWe report the 5-year analysis from the phase III Dasatinib Versus Imatinib Study in Treatment-Naïve Chronic Myeloid Leukemia Patients (DASISION) trial, evaluating long-term efficacy and safety outcomes of patients with chronic myeloid leukemia (CML) in chronic phase (CP) treated with dasatinib or imatinib. PATIENTS AND

methodsPatients with newly diagnosed CML-CP were randomly assigned to receive dasatinib 100 mg once daily (n = 259) or imatinib 400 mg once daily (n = 260).

resultsAt the time of study closure, 61% and 63% of dasatinib- and imatinib-treated patients remained on initial therapy, respectively. Cumulative rates of major molecular response and molecular responses with a 4.0- or 4.5-log reduction in BCR-ABL1 transcripts from baseline by 5 years remained statistically significantly higher for dasatinib compared with imatinib. Rates for progression-free and overall survival at 5 years remained high and similar across treatment arms. In patients who achieved BCR-ABL1 ≤ 10% at 3 months (dasatinib, 84%; imatinib, 64%), improvements in progression-free and overall survival and lower rates of transformation to accelerated/blast phase were reported compared with patients with BCR-ABL1 greater than 10% at 3 months. Transformation to accelerated/blast phase occurred in 5% and 7% of patients in the dasatinib and imatinib arms, respectively. Fifteen dasatinib-treated and 19 imatinib-treated patients had BCR-ABL1 mutations identified at discontinuation. There were no new or unexpected adverse events identified in either treatment arm, and pleural effusion was the only drug-related, nonhematologic adverse event reported more frequently with dasatinib (28% v 0.8% with imatinib). First occurrences of pleural effusion were reported with dasatinib, with the highest incidence in year 1. Arterial ischemic events were uncommon in both treatment arms.

conclusionThese final results from the DASISION trial continue to support dasatinib 100 mg once daily as a safe and effective first-line therapy for the long-term treatment of CML-CP.

Indexed as

AdultAgedDasatinibFusion Proteins, bcr-ablHumansImatinib MesylateLeukemia, Myeloid, Chronic-PhaseMiddle AgedMutationBCR-ABL1 fusion protein, humanDasatinibFusion Proteins, bcr-ablImatinib Mesylate

Identifiers

PMID27217448
PMCPMC5118045
OpenAlexW2397234997

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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.