Evidence map›Paper›PMID 32572189›Full record

Trial reportLeukemia2020

Bosutinib for pretreated patients with chronic phase chronic myeloid leukemia: primary results of the phase 4 BYOND study.

Andreas Hochhaus, Carlo Gambacorti-Passerini, Camille Abboud, Bjørn Tore Gjertsen, Tim H Brümmendorf, B Douglas Smith, Thomas Ernst, Pilar Giraldo-Castellano, Ulla Olsson-Strömberg, Susanne Saussele and 9 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IV
In one paragraph

Trial report in Leukemia, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02228382 (A PHASE 4 SAFETY AND EFFICACY STUDY OF BOSUTINIB), which is not on this map. Cited by 49 papers.

0numbers the graph read from it
0cells of the map it votes in
49citing papers in PubMed
6.2field-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.

NCT02228382 phase4terminatednot on this map

A phase 4 safety and efficacy study of bosutinib (bosulif (registered)) in patients with philadelphia chromosome positive chronic myeloid leukemia previously treated with one or more tyrosine kinase inhibitors

TypeinterventionalSponsorPfizerRan2014 to 2020Enrolled163ConditionsPreviously Treated PH + CMLArmsBosutinib
3 · Its place in the literature

Who cites it

49 citing papers in PubMed, 82 citations in OpenAlex.

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  11. Vascular Toxicities of Cancer Therapies: 2025 Update.Arteriosclerosis, thrombosis, and vascular biology · 2026
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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

19 authors at 20 institutions in 8 countries.

Andreas HochhausKlinik für Innere Medizin II, Universitätsklinikum Jena, Jena, Germany. andreas.hochhaus@med.uni-jena.de.
Carlo Gambacorti-PasseriniUniversity of Milano-Bicocca, Monza, Italy.
Camille AbboudWashington University School of Medicine, St. Louis, MO, USA.
Bjørn Tore GjertsenHaukeland University Hospital, Helse Bergen, and University of Bergen, Bergen, Norway.
Tim H BrümmendorfUniversitätsklinikum RWTH Aachen, Aachen, Germany.
B Douglas SmithJohns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD, USA.
Thomas ErnstKlinik für Innere Medizin II, Universitätsklinikum Jena, Jena, Germany.
Pilar Giraldo-CastellanoCIBER Enfermedades Raras, Miguel Servet University Hospital, Zaragoza, Spain.
Ulla Olsson-StrömbergUniversity of Uppsala and Department of Hematology, University Hospital, Uppsala, Sweden.
Susanne SausseleUniversitätsmedizin Mannheim, Heidelberg University, Mannheim, Germany.
Nathalie Bardy-BouxinPfizer International Operation-Oncology, Paris, France.
Andrea ViqueiraPfizer SLU, Madrid, Spain.
Eric LeipPfizer Inc, Cambridge, MA, USA.
T Alexander Russell-SmithPfizer Inc, New York, NY, USA.
Jocelyn LeonePfizer Inc, Cambridge, MA, USA.
Gianantonio RostiUniversity Hospital, University of Bologna, Bologna, Italy.
Justin WattsUniversity of Miami, Sylvester Comprehensive Cancer Center, Miami, FL, USA.
Francis J GilesDevelopmental Therapeutics Consortium, Chicago, IL, USA.
BYOND Study Investigators
Pfizer (United States) · USAzienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda · ITCentre Hospitalier Régional et Universitaire de Nancy · FRHospital Clínic de Barcelona · ESIndiana Cancer Consortium · USInnsbruck Medical University · ATInstitut Bergonié · FRJena University Hospital · DENewYork–Presbyterian Hospital · USSeattle Cancer Care Alliance · USUniversität Hamburg · DEUniversity of Southern California · USAzienda Universitaria Ospedaliera Consorziale - Policlinico Bari · ITCentre de Recherche en Cancérologie de Marseille · FRCentre for Palaeogenetics · SECentro de Investigación Biomédica en Red · ESComplejo Hospitalario de Salamanca · ESHaukeland University Hospital · NOHeidelberg University · DEHospital Universitari i Politècnic La Fe · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Bosutinib is approved for newly diagnosed Philadelphia chromosome-positive (Ph+) chronic phase (CP) chronic myeloid leukemia (CML) and for Ph+ CP, accelerated (AP), or blast (BP) phase CML after prior treatment with tyrosine kinase inhibitors (TKIs). In the ongoing phase 4 BYOND study (NCT02228382), 163 CML patients resistant/intolerant to prior TKIs (n = 156 Ph+ CP CML, n = 4 Ph+ AP CML, n = 3 Ph-negative/BCR-ABL1+ CML) received bosutinib 500 mg once daily (starting dose). As of ≥1 year after last enrolled patient (median treatment duration 23.7 months), 56.4% of Ph+ CP CML patients remained on bosutinib. Primary endpoint of cumulative confirmed major cytogenetic response (MCyR) rate by 1 year was 75.8% in Ph+ CP CML patients after one or two prior TKIs and 62.2% after three prior TKIs. Cumulative complete cytogenetic response (CCyR) and major molecular response (MMR) rates by 1 year were 80.6% and 70.5%, respectively, in Ph+ CP CML patients overall. No patient progressed to AP/BP on treatment. Across all patients, the most common treatment-emergent adverse events were diarrhea (87.7%), nausea (39.9%), and vomiting (32.5%). The majority of patients had confirmed MCyR by 1 year and MMR by 1 year, further supporting bosutinib use for Ph+ CP CML patients resistant/intolerant to prior TKIs.

Indexed as

AdultAgedAged, 80 and overAniline CompoundsFemaleHumansLeukemia, Myeloid, Chronic-PhaseMaleMiddle AgedNitrilesPhiladelphia ChromosomeProtein Kinase InhibitorsProtein-Tyrosine KinasesQuality of LifeQuinolinesAniline CompoundsbosutinibNitrilesProtein Kinase InhibitorsProtein-Tyrosine KinasesQuinolines

Identifiers

PMID32572189
PMCPMC7387243
OpenAlexW3036304464

What OpenQuestion holds

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LicenceCC BY
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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.