Evidence map›Paper›PMID 22371878›Full record

Trial reportBlood2012

Bosutinib is active in chronic phase chronic myeloid leukemia after imatinib and dasatinib and/or nilotinib therapy failure.

H Jean Khoury, Jorge E Cortes, Hagop M Kantarjian, Carlo Gambacorti-Passerini, Michele Baccarani, Dong-Wook Kim, Andrey Zaritskey, Athena Countouriotis, Nadine Besson, Eric Leip and 2 more

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

Trial report in Blood, 2012. 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 132 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
132citing papers in PubMed, 2 pooled it
23.7field-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

132 citing papers in PubMed, 2 syntheses or guidelines pooled it, 315 citations in OpenAlex.

  1. Pooled it
  2. Chronic Myelogenous Leukemia, Version 1.2014.Journal of the National Comprehensive Cancer Network : JNCCN · 2013
    Guideline
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72 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

12 authors at 9 institutions in 6 countries.

H Jean KhouryWinship Cancer Institute of Emory University, Atlanta, GA 30322, USA. hkhoury@emory.edu
Jorge E Cortes
Hagop M Kantarjian
Carlo Gambacorti-Passerini
Michele Baccarani
Dong-Wook Kim
Andrey Zaritskey
Athena Countouriotis
Nadine Besson
Eric Leip
Virginia Kelly
Tim H Brümmendorf
Pfizer (United States) · USThe University of Texas MD Anderson Cancer Center · USEmory University · USFirst Pavlov State Medical University of St. Petersburg · RUPfizer (France) · FRSeoul St. Mary's Hospital · KRUniversität Hamburg · 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
6 · The paper itself

Abstract

Bosutinib, a dual Src/Abl tyrosine kinase inhibitor (TKI), has shown potent activity against chronic myeloid leukemia (CML). This phase 1/2 study evaluated the efficacy and safety of once-daily bosutinib 500 mg in leukemia patients after resistance/intolerance to imatinib. The current analysis included 118 patients with chronic-phase CML who had been pretreated with imatinib followed by dasatinib and/or nilotinib, with a median follow-up of 28.5 months. In this subpopulation, major cytogenetic response was attained by 32% of patients; complete cytogenetic response was attained by 24%, including in one of 3 patients treated with 3 prior TKIs. Complete hematologic response was achieved/maintained in 73% of patients. On-treatment transformation to accelerated/blast phase occurred in 5 patients. At 2 years, Kaplan-Meier-estimated progression-free survival was 73% and estimated overall survival was 83%. Responses were seen across Bcr-Abl mutations, including those associated with dasatinib and nilotinib resistance, except T315I. Bosutinib had an acceptable safety profile; treatment-emergent adverse events were primarily manageable grade 1/2 gastrointestinal events and rash. Grade 3/4 nonhematologic adverse events (> 2% of patients) included diarrhea (8%) and rash (4%). Bosutinib may offer a new treatment option for patients with chronic-phase CML after treatment with multiple TKIs. This trial was registered at www.clinicaltrials.gov as NCT00261846.

Indexed as

AdultAgedAlgorithmsAniline CompoundsAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsBenzamidesChemotherapy, AdjuvantDasatinibDrug Resistance, NeoplasmFemaleHumansImatinib MesylateLeukemia, Myeloid, Chronic-PhaseMaleMiddle AgedAniline CompoundsAntineoplastic AgentsBenzamidesbosutinibDasatinibImatinib MesylatenilotinibNitrilesPiperazinesPyrimidinesQuinolinesThiazoles

Identifiers

PMID22371878
PMCPMC4916559
OpenAlexW2057796192

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.