Evidence map›Paper›PMID 27192969›Full record

Trial reportAmerican journal of hematology2016

Dasatinib in imatinib-resistant or -intolerant chronic-phase, chronic myeloid leukemia patients: 7-year follow-up of study CA180-034.

Neil P Shah, Philippe Rousselot, Charles Schiffer, Delphine Rea, Jorge E Cortes, Jorge Milone, Hesham Mohamed, Diane Healey, Hagop Kantarjian, Andreas Hochhaus and 1 more

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

Trial report in American journal of hematology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00123474 (A Randomized Two-by-Two, Multicenter, Open-Label Phase III Study of BMS-354825 Administered Orally at a Dose of 50 mg or 70 mg Twice Daily or 100 mg or 140 mg Once Daily in Subjects With Chronic Phase Philadelphia Chromosome or BCR-ABL Positive Chronic Myelogenous Leukemia Who Are Resistant or Intolerant to Imatinib Mesylate), which is not on this map. Cited by 91 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
91citing 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.

NCT00123474 phase3completednot on this map

A Randomized Two-by-Two, Multicenter, Open-Label Phase III Study of BMS-354825 Administered Orally at a Dose of 50 mg or 70 mg Twice Daily or 100 mg or 140 mg Once Daily in Subjects With Chronic Phase Philadelphia Chromosome or BCR-ABL Positive Chronic Myelogenous Leukemia Who Are Resistant or Intolerant to Imatinib Mesylate (Gleevec)

TypeinterventionalSponsorBristol-Myers SquibbRan2005 to 2014Enrolled724ConditionsMyeloid Leukemia, Chronic, Chronic-PhaseArmsdasatinib
3 · Its place in the literature

Who cites it

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

  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. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. 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
    Trial
  10. Article
  11. Review
  12. Observational
  13. Article
  14. Article
  15. Article
  16. Review
  17. Article
  18. Article
  19. Review
  20. Dose Optimization of Tyrosine Kinase Inhibitors for Chronic Myeloid Leukemia.Clinical pharmacology : advances and applications · 2025
    Review

31 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

11 authors.

Neil P ShahUCSF School of Medicine, San Francisco, California.
Philippe RousselotHôpital André Mignot and Université Versailles Saint-Quentin-en-Yvelines, Versailles, France.
Charles SchifferWayne State University School of Medicine, Detroit, Michigan.
Delphine ReaSaint Louis Hospital, Paris, France.
Jorge E CortesUniversity of Texas M.D. Anderson Cancer Center, Houston, Texas.
Jorge MiloneHospital Italiano De La Plata, La Plata, Argentina.
Hesham MohamedBristol-Myers Squibb, Princeton, New Jersey.
Diane HealeyBristol-Myers Squibb, Princeton, New Jersey.
Hagop KantarjianUniversity of Texas M.D. Anderson Cancer Center, Houston, Texas.
Andreas HochhausUniversitätsklinikum Jena, Jena, Germany.
Giuseppe SaglioUniversity of Turin, Turin, Italy.

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
NCI NIH HHS P30 CA016672
6 · The paper itself

Abstract

Dasatinib was approved at 100 mg once daily for imatinib-resistant or -intolerant patients with chronic myeloid leukemia (CML) in chronic phase, based on results of the phase 3 CA180-034 (NCT00123474) study. Here we present the final 7-year analysis of this pivotal study, the longest follow-up to date of any second-generation BCR-ABL1 tyrosine kinase inhibitor (TKI). Patients (n = 670) with imatinib-resistant or -intolerant CML in chronic phase received dasatinib. Nineteen percent of patients continued on study treatment, with a greater proportion in the 100 mg once daily arm remaining on therapy. Seven-year rates for major molecular response (MMR), progression-free survival (PFS), and overall survival (OS) were similar across doses; MMR, PFS, and OS results were 46, 42, and 65% at 100 mg once daily, respectively. Improved PFS and OS rates were reported in patients who achieved BCR-ABL1 ≤10% at 3 and 6 months. No new safety signals were identified. The incidence of drug-related pleural effusion was 28% at 100 mg once daily and 35% at the other three dose groups. Incidence of drug-related pulmonary hypertension and pulmonary arterial hypertension remained low (≤3% across all doses). Arterial ischemic events occurred in ≤4% of patients across all doses. These data support the long-term efficacy and well-established safety profile of dasatinib for patients with imatinib-resistant or -intolerant CML in chronic phase. Am. J. Hematol. 91:869-874, 2016. © 2016 Wiley Periodicals, Inc.

Indexed as

Antineoplastic AgentsDasatinibDisease-Free SurvivalDrug Resistance, NeoplasmFollow-Up StudiesHumansImatinib MesylateLeukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, Myeloid, Chronic-PhasePancytopeniaPatient SafetyPleural EffusionProtein Kinase InhibitorsTreatment OutcomeAntineoplastic AgentsDasatinibImatinib MesylateProtein Kinase Inhibitors

Identifiers

PMID27192969
PMCPMC5094534

What OpenQuestion holds

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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.