Evidence map›Paper›PMID 24711212›Full record

Trial reportAmerican journal of hematology2014

Bosutinib efficacy and safety in chronic phase chronic myeloid leukemia after imatinib resistance or intolerance: Minimum 24-month follow-up.

Carlo Gambacorti-Passerini, Tim H Brümmendorf, Dong-Wook Kim, Anna G Turkina, Tamas Masszi, Sarit Assouline, Simon Durrant, Hagop M Kantarjian, H Jean Khoury, Andrey Zaritskey and 11 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in American journal of hematology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00261846 (A Phase 1/2 Study Of Bosutinib), which is not on this map. Cited by 54 papers.

0numbers the graph read from it
0cells of the map it votes in
54citing papers in PubMed
9.7field-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.

NCT00261846 phase2completednot on this map

A Phase 1/2 Study Of Bosutinib (Ski-606) In Philadelphia Chromosome Positive Leukemias

TypeinterventionalSponsorPfizerRan2006 to 2015Enrolled571ConditionsChronic Myeloid LeukemiaArmsBosutinib
3 · Its place in the literature

Who cites it

54 citing papers in PubMed, 116 citations in OpenAlex.

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  8. 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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  9. Bosutinib versus Placebo for Autosomal Dominant Polycystic Kidney Disease.Journal of the American Society of Nephrology : JASN · 2017
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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

21 authors at 18 institutions in 14 countries.

Carlo Gambacorti-PasseriniUniversity of Milano-Bicocca, San Gerardo Hospital, Monza, Italy.
Tim H Brümmendorf
Dong-Wook Kim
Anna G Turkina
Tamas Masszi
Sarit Assouline
Simon Durrant
Hagop M Kantarjian
H Jean Khoury
Andrey Zaritskey
Zhi-Xiang Shen
Jie Jin
Edo Vellenga
Ricardo Pasquini
Vikram Mathews
Francisco Cervantes
Nadine Besson
Kathleen Turnbull
Eric Leip
Virginia Kelly
Jorge E Cortes
Pfizer (United States) · USThe University of Texas MD Anderson Cancer Center · USChristian Medical College & Hospital · INEmory University · USEndocrinology Research Center · RUFederal Almazov North-West Medical Research Centre · RUFirst Affiliated Hospital Zhejiang University · CNHospital Clínic de Barcelona · ESHospital de Clínicas Universidade Federal do Paraná · BRMcGill University · CAPfizer (France) · FRRoyal Brisbane and Women's Hospital · AURuijin Hospital · CNSeoul St. Mary's Hospital · KRUnified Szent István and Szent László Hospital · HUUniversitätsklinikum Aachen · DEUniversity of Groningen · NLUniversity 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 orally active, dual Src/Abl tyrosine kinase inhibitor for treatment of chronic myeloid leukemia (CML) following resistance/intolerance to prior therapy. Here, we report the data from the 2-year follow-up of a phase 1/2 open-label study evaluating the efficacy and safety of bosutinib as second-line therapy in 288 patients with chronic phase CML resistant (n = 200) or intolerant (n = 88) to imatinib. The cumulative response rates to bosutinib were as follows: 85% achieved/maintained complete hematologic response, 59% achieved/maintained major cytogenetic response (including 48% with complete cytogenetic response), and 35% achieved major molecular response. Responses were durable, with 2-year estimates of retaining response >70%. Two-year probabilities of progression-free survival and overall survival were 81% and 91%, respectively. The most common toxicities were primarily gastrointestinal adverse events (diarrhea [84%], nausea [45%], vomiting [37%]), which were primarily mild to moderate, typically transient, and first occurred early during treatment. Thrombocytopenia was the most common grade 3/4 hematologic laboratory abnormality (24%). Outcomes were generally similar among imatinib-resistant and imatinib-intolerant patients and did not differ with age. The longer-term results of the present analysis confirm that bosutinib is an effective and tolerable second-line therapy for patients with imatinib-resistant or imatinib-intolerant chronic phase CML. ClinicalTrials.gov Identifier: NCT00261846.

Indexed as

AdolescentAdultAgedAged, 80 and overAniline CompoundsAntineoplastic AgentsBenzamidesDisease-Free SurvivalDose-Response Relationship, DrugDrug Resistance, NeoplasmFemaleFollow-Up StudiesHumansImatinib MesylateLeukemia, Myeloid, Chronic-PhaseMaleAniline CompoundsAntineoplastic AgentsBenzamidesbosutinibImatinib MesylateNitrilesPiperazinesProtein Kinase InhibitorsPyrimidinesQuinolines

Identifiers

PMID24711212
PMCPMC4173127
OpenAlexW2150604072

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.