Evidence map›Paper›PMID 37246588›Full record

ArticleBritish journal of haematology2023

Treatment-free remission after dasatinib in patients with chronic myeloid leukaemia in chronic phase with deep molecular response: Final 5-year analysis of DASFREE.

Neil P Shah, Valentín García-Gutiérrez, Antonio Jiménez-Velasco, Sarah M Larson, Susanne Saussele, Delphine Rea, François-Xavier Mahon, Moshe Yair Levy, María Teresa Gómez-Casares, Michael J Mauro and 3 more

Registry-linked trialOpen access · bronzeAbstract read
In one paragraph

Article in British journal of haematology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01850004 (Open-Label Single Arm Phase 2 Study Evaluating Dasatinib Therapy Discontinuation In Patients With Chronic Phase Chronic Myeloid Leukemia), which is not on this map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
6.1field-weighted citation impact, top 3% 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.

NCT01850004 phase2completednot on this map

Open-Label Single Arm Phase 2 Study Evaluating Dasatinib Therapy Discontinuation In Patients With Chronic Phase Chronic Myeloid Leukemia (CP-CML) With Stable Complete Molecular Response (CMR) DASFREE

TypeinterventionalSponsorBristol-Myers SquibbRan2014 to 2021Enrolled84ConditionsChronic Phase Chronic Myeloid LeukemiaArmsDasatinib
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 1 synthesis or guideline pooled it, 21 citations in OpenAlex.

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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

13 authors at 12 institutions in 5 countries.

Neil P ShahUCSF School of Medicine, San Francisco, California, USA.ORCID 0000-0003-4398-3388
Valentín García-GutiérrezServicio Hematología y Hemoterapia, Hospital Universitario Ramón y Cajal, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS), Madrid, Spain.
Antonio Jiménez-VelascoServicio de Hematología y Hemoterapia, Hospital Regional Universitario de Málaga, IBIMA, Málaga, Spain.
Sarah M LarsonDavid Geffen School of Medicine at UCLA, Los Angeles, California, USA.
Susanne SausseleMedizinische Fakultät Mannheim der Universität Heidelberg, Mannheim, Germany.
Delphine ReaAdult Hematology Department, Hôpital Saint-Louis, Paris, France.ORCID 0000-0001-5379-7461
François-Xavier MahonInstitut Bergonié Cancer Center, Université Bordeaux, Bordeaux, France.
Moshe Yair LevyBaylor Charles A. Sammons Cancer Center, Dallas, Texas, USA.
María Teresa Gómez-CasaresHospital Universitario de Gran Canaria Dr. Negrín, Las Palmas de Gran Canaria, Spain.
Michael J MauroMemorial Sloan Kettering Cancer Center, New York, New York, USA.
Oumar SyBristol Myers Squibb, Princeton, New Jersey, USA.
Patricia Martin-RegueiraBristol Myers Squibb, Princeton, New Jersey, USA.
Jeffrey H LiptonPrincess Margaret Cancer Centre, University of Toronto, Toronto, Ontario, Canada.
Bristol-Myers Squibb (United States) · USHeidelberg University · DEHôpital Saint-Louis · FRHospital Regional Universitario de Málaga · ESHospital Universitario de Gran Canaria Doctor Negrín · ESInstitut Bergonié · FRInstituto Ramón y Cajal de Investigación Sanitaria · ESMemorial Sloan Kettering Cancer Center · USTexas Oncology · USUniversity of California, Los Angeles · USUniversity of California, San Francisco · USUniversity of Toronto · CA

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
Translational InformaticsP30CA082103 · NCI · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI Kate Taylor Shumate · 1999 to 2026
$209.7M
NCI NIH HHS P30 CA008748NCI NIH HHS P30 CA082103
6 · The paper itself

Abstract

Patients with chronic myeloid leukaemia in chronic phase (CML-CP) who have a sustained deep molecular response (DMR) are eligible to discontinue treatment and attempt treatment-free remission (TFR). In the DASFREE study (ClinicalTrials.gov; NCT01850004), the 2-year TFR rate after dasatinib discontinuation was 46%; here we present the 5-year update. Patients with a stable DMR after ≥2 years of dasatinib therapy discontinued treatment and were followed for 5 years. At a minimum follow-up of 60 months, in 84 patients discontinuing dasatinib, the 5-year TFR rate was 44% (n = 37). No relapses occurred after month 39 and all evaluable patients who relapsed and restarted dasatinib (n = 46) regained a major molecular response in a median of 1.9 months. The most common adverse event during the off-treatment period was arthralgia (18%, 15/84); a total of 15 withdrawal events were reported in nine patients (11%). At the 5-year final follow-up, almost half of the patients who discontinued dasatinib after a sustained DMR maintained TFR. All evaluable patients who experienced a relapse quickly regained a DMR after restarting dasatinib, demonstrating that dasatinib discontinuation is a viable and potentially long-term option in patients with CML-CP. The safety profile is consistent with the previous report.

Indexed as

Leukemia, Myelogenous, Chronic, BCR-ABL PositiveProtein Kinase InhibitorsDasatinibHumansNeoplasm Recurrence, LocalTreatment OutcomeDasatinibProtein Kinase Inhibitorschronic phase chronic myeloid leukaemiadasatinibdeep molecular responsemajor molecular responsetreatment-free remission

Identifiers

PMID37246588
PMCPMC10524617
OpenAlexW4378640330

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.