Evidence map›Paper›PMID 24345751›Full record

Trial reportBlood2014

Bosutinib safety and management of toxicity in leukemia patients with resistance or intolerance to imatinib and other tyrosine kinase inhibitors.

Hagop M Kantarjian, Jorge E Cortes, Dong-Wook Kim, H Jean Khoury, Tim H Brümmendorf, Kimmo Porkka, Giovanni Martinelli, Simon Durrant, Eric Leip, Virginia Kelly and 3 more

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

Trial report in Blood, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT00261846 (A Phase 1/2 Study Of Bosutinib), which is not on this map. Cited by 71 papers.

0numbers the graph read from it
0cells of the map it votes in
71citing papers in PubMed
9.3field-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

71 citing papers in PubMed, 149 citations in OpenAlex.

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11 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 10 institutions in 7 countries.

Hagop M KantarjianDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX;
Jorge E Cortes
Dong-Wook Kim
H Jean Khoury
Tim H Brümmendorf
Kimmo Porkka
Giovanni Martinelli
Simon Durrant
Eric Leip
Virginia Kelly
Kathleen Turnbull
Nadine Besson
Carlo Gambacorti-Passerini
The University of Texas MD Anderson Cancer Center · USEmory University · USHelsinki University Hospital · FIPfizer (France) · FRPfizer (United States) · USRoyal Brisbane and Women's Hospital · AUSeoul St. Mary's Hospital · KRUniversitätsklinikum Aachen · DEUniversity of Bologna · ITUniversity 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/ABL tyrosine kinase inhibitor (TKI) with clinical activity in Philadelphia chromosome-positive (Ph(+)) leukemia. We assessed the safety and tolerability of bosutinib 500 mg per day in a phase 1/2 study in chronic-phase (CP) chronic myeloid leukemia (CML) or advanced Ph(+) leukemia following resistance/intolerance to imatinib and possibly other TKIs. Patient cohorts included second-line CP CML (n = 286), third-/fourth-line CP CML (n = 118), and advanced leukemia (n = 166). Median bosutinib duration was 11.1 (range, 0.03-83.4) months. Treatment-emergent adverse events (TEAEs) in each cohort were primarily gastrointestinal (diarrhea [86%/83%/74%], nausea [46%/48%/48%], and vomiting [37%/38%/43%]). Diarrhea presented early, with few (8%) patients experiencing grade 3/4 events; dose reduction due to diarrhea occurred in 6% of affected patients. Grade 3/4 myelosuppression TEAEs were reported in 41% of patients; among affected patients, 46% were managed with bosutinib interruption and 32% with dose reduction. Alanine aminotransferase elevation TEAEs occurred in 17% of patients (grade 3/4, 7%); among patients managed with dose interruption, bosutinib rechallenge was successful in 74%. Bosutinib demonstrated acceptable safety with manageable toxicities in Ph(+) leukemia. This trial (NCT00261846) was registered at www.ClinicalTrials.gov (this manuscript is based on a different data snapshot from that in ClinicalTrials.gov).

Indexed as

AdolescentAdultAgedAged, 80 and overAniline CompoundsBenzamidesDose-Response Relationship, DrugDrug-Related Side Effects and Adverse ReactionsDrug Resistance, NeoplasmFemaleHumansImatinib MesylateLeukemia, Myelogenous, Chronic, BCR-ABL PositiveMaleMiddle AgedNitrilesAniline CompoundsBenzamidesbosutinibImatinib MesylateNitrilesPiperazinesProtein Kinase InhibitorsProtein-Tyrosine KinasesPyrimidinesQuinolines

Identifiers

PMID24345751
PMCPMC4467890
OpenAlexW2059705970

What OpenQuestion holds

Textmetadata
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.