Evidence map›Paper›PMID 31553487›Full record

Trial reportCancer2020

Long-term follow-up of lower dose dasatinib (50 mg daily) as frontline therapy in newly diagnosed chronic-phase chronic myeloid leukemia.

Kiran Naqvi, Elias Jabbour, Jeffrey Skinner, Kristin Anderson, Sara Dellasala, Musa Yilmaz, Alessandra Ferrajoli, Prithviraj Bose, Philip Thompson, Yesid Alvarado and 9 more

Registry-linked trialAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Cancer, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05638763 (Cytochrome P450 Inhibition With Ketoconazole to Decrease Dosage and Costs of Dasatinib for Chronic Myelogenous Leukemia), which is not on this map. Cited by 61 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
61citing 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.

NCT05638763 phase2unknown statusnot on this mapstarted 2024, after this paper: background citation

Cytochrome P450 Inhibition With Ketoconazole to Decrease Dosage and Costs of Dasatinib for Chronic Myelogenous Leukemia

TypeinterventionalSponsorHospital Universitario Dr. Jose E. GonzalezRan2024 to 2024Enrolled15ConditionsChronic Myeloid Leukemia, Chronic PhaseArmsDasatinib Pill, Ketoconazole Pill
3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Trial
  3. Trial
  4. Review
  5. Review
  6. Observational
  7. Review
  8. Article
  9. Article
  10. Review
  11. Article
  12. Chronic Myeloid Leukemia and the T315IInternational journal of molecular sciences · 2025
    Review
  13. Article
  14. Article
  15. Article
  16. Review
  17. Dose Optimization of Tyrosine Kinase Inhibitors for Chronic Myeloid Leukemia.Clinical pharmacology : advances and applications · 2025
    Review
  18. Article
  19. Article
  20. Tumor biomarkers for diagnosis, prognosis and targeted therapy.Signal transduction and targeted therapy · 2024
    Review

1 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

19 authors.

Kiran NaqviThe University of Texas MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0002-5511-6153
Elias JabbourThe University of Texas MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0003-4465-6119
Jeffrey SkinnerThe University of Texas MD Anderson Cancer Center, Houston, Texas.
Kristin AndersonThe University of Texas MD Anderson Cancer Center, Houston, Texas.
Sara DellasalaThe University of Texas MD Anderson Cancer Center, Houston, Texas.
Musa YilmazThe University of Texas MD Anderson Cancer Center, Houston, Texas.
Alessandra FerrajoliThe University of Texas MD Anderson Cancer Center, Houston, Texas.
Prithviraj BoseThe University of Texas MD Anderson Cancer Center, Houston, Texas.
Philip ThompsonThe University of Texas MD Anderson Cancer Center, Houston, Texas.
Yesid AlvaradoThe University of Texas MD Anderson Cancer Center, Houston, Texas.
Nitin JainThe University of Texas MD Anderson Cancer Center, Houston, Texas.
Koichi TakahashiThe University of Texas MD Anderson Cancer Center, Houston, Texas.
Jan BurgerThe University of Texas MD Anderson Cancer Center, Houston, Texas.
Zeev EstrovThe University of Texas MD Anderson Cancer Center, Houston, Texas.
Gautam BorthakurThe University of Texas MD Anderson Cancer Center, Houston, Texas.
Naveen PemmarajuThe University of Texas MD Anderson Cancer Center, Houston, Texas.
Shilpa PaulThe University of Texas MD Anderson Cancer Center, Houston, Texas.
Jorge CortesThe University of Texas MD Anderson Cancer Center, Houston, Texas.
Hagop M KantarjianThe University of Texas MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0002-1908-3307

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Fabien Delerue · 1985 to 2026
$290.8M
University of Texas M.D. Anderson Cancer SPORE-LeukemiaP50CA100632 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI SHPALL, ELIZABETH J · 2003 to 2023
$43.7M
NCI NIH HHS P30 CA016672NCI NIH HHS P50 CA100632NIH HHS P30 CA016672
6 · The paper itself

Abstract

backgroundDasatinib, a potent Bcr-Abl tyrosine kinase inhibitor, is approved for the treatment of chronic-phase chronic myeloid leukemia (CML-CP) in the frontline and salvage settings. Notable side effects include pleural effusions and myelosuppression. Dasatinib at 50 mg daily has previously been reported to be active and better tolerated than the approved 100-mg daily dose. The aim of this study was to update the long-term follow-up results of dasatinib at 50 mg daily as frontline therapy for CML-CP.

methodsEighty-three patients with newly diagnosed CML-CP received dasatinib at 50 mg daily. Eligibility and response criteria were standards used in previous protocols.

resultsAfter a minimum follow-up of 12 months, 81 patients were evaluable. Two patients came off the study in less than 3 months. The rates of BCR-ABL1 transcript levels (International Standard) at ≤10% and ≤1% at 3 months were 96% and 77%, respectively. The cumulative rates for a complete cytogenetic response by 6 and 12 months were 77% and 95%, respectively. The cumulative rates for a major molecular response, a molecular response with a 4.0-log reduction, and a molecular response with a 4.5-log reduction by 12 months were 81%, 55%, and 49%, respectively. Twenty-one patients (25%) had treatment interruptions for a median of 13 days (range, 4-64 days). Five patients (6%) developed pleural effusions; 4 of these patients (80%) required a dose reduction. Two patients (2%) failed to achieve any cytogenetic or molecular response and were taken off the study. At a median follow-up of 24 months, none of the patients had disease transformation to an accelerated or blastic phase. The 2-year event-free and overall survival rates were 100%.

conclusionsThese updated results continue to support 50 mg of dasatinib daily as an effective and safe dose for early CML-CP.

Indexed as

AdultAgedAged, 80 and overBridged Bicyclo Compounds, HeterocyclicDasatinibDisease-Free SurvivalDose-Response Relationship, DrugFemaleFollow-Up StudiesFusion Proteins, bcr-ablHumansImatinib MesylateLeukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, Myeloid, Chronic-PhaseMaleMiddle AgedBridged Bicyclo Compounds, HeterocyclicDasatinibFusion Proteins, bcr-ablImatinib MesylateProtein Kinase InhibitorsSulfonamidesvenetoclaxchronic myeloid leukemiacomplete cytogenetic responsedasatinibmajor molecular response

Identifiers

PMID31553487
PMCPMC8529949

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.