Evidence map›Paper›PMID 25196702›Full record

Trial reportBritish journal of haematology2015

Bosutinib versus imatinib in newly diagnosed chronic-phase chronic myeloid leukaemia: results from the 24-month follow-up of the BELA trial.

Tim H Brümmendorf, Jorge E Cortes, Cármino Antonio de Souza, Francois Guilhot, Ladan Duvillié, Dmitri Pavlov, Karïn Gogat, Athena M Countouriotis, Carlo Gambacorti-Passerini

Open access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in British journal of haematology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 90 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
90citing papers in PubMed, 3 pooled it
13.0field-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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

90 citing papers in PubMed, 3 syntheses or guidelines pooled it, 191 citations in OpenAlex.

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  12. Bosutinib Versus Imatinib for Newly Diagnosed Chronic Myeloid Leukemia: Results From the Randomized BFORE Trial.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2018
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30 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

9 authors at 7 institutions in 5 countries.

Tim H BrümmendorfUniversitätsklinikum Aachen, RWTH Aachen, Aachen, Germany; Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany.
Jorge E Cortes
Cármino Antonio de Souza
Francois Guilhot
Ladan Duvillié
Dmitri Pavlov
Karïn Gogat
Athena M Countouriotis
Carlo Gambacorti-Passerini
Pfizer (France) · FRPfizer (United States) · USCentre Hospitalier Universitaire de Poitiers · FRThe University of Texas MD Anderson Cancer Center · USUniversidade Estadual de Campinas (UNICAMP) · BRUniversitätsklinikum Aachen · DEUniversity of Milano-Bicocca · IT

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

Bosutinib is an oral, dual SRC/ABL1 tyrosine kinase inhibitor for resistant/intolerant chronic myeloid leukaemia (CML). We assessed the efficacy and safety of bosutinib 500 mg/d (n = 250) versus imatinib 400 mg/d (n = 252) after >24 months from accrual completion in newly diagnosed chronic phase (CP)-CML (Bosutinib Efficacy and Safety in Newly Diagnosed CML trial [BELA]). Cumulative complete cytogenetic response (CCyR) rates by 24 months were similar (bosutinib, 79%; imatinib, 80%); cumulative major molecular response (MMR) rates were 59% for bosutinib and 49% for imatinib. Responses were durable; 151/197 vs. 172/204 and 125/153 vs. 117/131 responders remained on treatment and maintained CCyR and MMR, respectively. Since the 12-month primary analysis, no new accelerated-/blast-phase transformations occurred with bosutinib; four occurred with imatinib. Early response (BCR-ABL1/ABL1 ≤ 10%, 3 months) was associated with better CCyR and MMR rates by 12 and 24 months (both arms). Gastrointestinal events and liver function test elevations were more common, and neutropenia, musculoskeletal events and oedema were less common with bosutinib. Discontinuations due to adverse events were more common with bosutinib versus imatinib (most commonly alanine aminotransferase elevation: 4% vs. <1%); most occurred within the first 12 months. Cardiovascular adverse events were similar in both arms. Bosutinib continues to demonstrate good efficacy and manageable tolerability in newly diagnosed CP-CML patients.

Indexed as

AgedAged, 80 and overAniline CompoundsAntineoplastic AgentsBenzamidesFemaleFollow-Up StudiesFusion Proteins, bcr-ablHumansImatinib MesylateLeukemia, Myeloid, Chronic-PhaseMaleMiddle AgedMutationNitrilesOdds RatioAniline CompoundsAntineoplastic AgentsBenzamidesbosutinibFusion Proteins, bcr-ablImatinib MesylateNitrilesPiperazinesProtein Kinase InhibitorsPyrimidinesQuinolinesBCR-ABL1bosutinibchronic myeloid leukaemiaCMLtyrosine kinase inhibitor

Identifiers

PMID25196702
PMCPMC4274978
OpenAlexW2052923507

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.