Evidence map›Paper›PMID 26537529›Full record

Trial reportBritish journal of haematology2016

Factors influencing long-term efficacy and tolerability of bosutinib in chronic phase chronic myeloid leukaemia resistant or intolerant to imatinib.

Tim H Brümmendorf, Jorge E Cortes, Hanna J Khoury, Hagop M Kantarjian, Dong-Wook Kim, Philippe Schafhausen, Maureen G Conlan, Mark Shapiro, Kathleen Turnbull, Eric Leip and 2 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in British journal of haematology, 2016. 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 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed
4.6field-weighted citation impact, top 5% 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

21 citing papers in PubMed, 42 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Trial
  4. 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
    Trial
  5. Bosutinib versus Placebo for Autosomal Dominant Polycystic Kidney Disease.Journal of the American Society of Nephrology : JASN · 2017
    Trial
  6. Trial
  7. Trial
  8. Article
  9. Review
  10. Article
  11. Article
  12. Review
  13. [Chronic granulocytic leukemia with COVID-19 pneumonia: a case report].Zhonghua xue ye xue za zhi = Zhonghua xueyexue zazhi · 2020
    Article
  14. Article
  15. Review
  16. Review
  17. Article
  18. Review
  19. Review
  20. Article
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 8 institutions in 5 countries.

Tim H BrümmendorfUniversitätsklinikum RWTH Aachen, Aachen, Germany.
Jorge E CortesUniversity of Texas MD, Anderson Cancer Center, Houston, TX, USA.
Hanna J KhouryWinship Cancer Institute of Emory University, Atlanta, GA, USA.
Hagop M KantarjianUniversity of Texas MD, Anderson Cancer Center, Houston, TX, USA.
Dong-Wook KimSeoul St. Mary's Hospital, Seoul, South Korea.
Philippe SchafhausenDepartment of Internal Medicine II, Hubertus Wald Tumorzentrum University Cancer Centre Hamburg, Hamburg, Germany.
Maureen G ConlanPfizer Inc, La Jolla, CA, USA.
Mark ShapiroPfizer Inc, Cambridge, MA, USA.
Kathleen TurnbullPfizer Inc, Cambridge, MA, USA.
Eric LeipPfizer Inc, Cambridge, MA, USA.
Carlo Gambacorti-PasseriniUniversity of Milano-Bicocca, Monza, Italy.
Jeff H LiptonPrincess Margaret Cancer Centre, Toronto, ON, Canada.
Pfizer (United States) · USThe University of Texas MD Anderson Cancer Center · USEmory University · USPrincess Margaret Cancer Centre · CASeoul St. Mary's Hospital · KRUniversitätsklinikum Aachen · DEUniversity Cancer Center Hamburg · 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

The dual SRC/ABL1 tyrosine kinase inhibitor bosutinib is indicated for adults with Ph+ chronic myeloid leukaemia (CML) resistant/intolerant to prior therapy. This analysis of an ongoing phase 1/2 study (NCT00261846) assessed effects of baseline patient characteristics on long-term efficacy and safety of bosutinib 500 mg/day in adults with imatinib (IM)-resistant (IM-R; n = 196)/IM-intolerant (IM-I; n = 90) chronic phase (CP) CML. Median treatment duration was 24·8 months (median follow-up, 43·6 months). Cumulative major cytogenetic response (MCyR) rate [95% confidence interval (CI)], was 59% (53-65%); Kaplan-Meier (KM) probability of maintaining MCyR at 4 years was 75% (66-81%). Cumulative incidence of on-treatment progression/death at 4 years was 19% (95% CI, 15-24%); KM 2-year overall survival was 91% (87-94%). Significant baseline predictors of both MCyR and complete cytogenetic response (newly attained/maintained from baseline) at 3 and 6 months included prior IM cytogenetic response, baseline MCyR, prior interferon therapy and <6 months duration from diagnosis to IM treatment initiation and no interferon treatment before IM. The most common adverse event (AE) was diarrhoea (86%). Baseline bosutinib-sensitive BCR-ABL1 mutation was the only significant predictor of grade 3/4 diarrhoea; no significant predictors were identified for liver-related AEs. Bosutinib demonstrates durable efficacy and manageable toxicity in IM-R/IM-I CP-CML patients.

Indexed as

AdolescentAdultAgedAged, 80 and overAge FactorsAniline CompoundsAntineoplastic AgentsDrug Resistance, NeoplasmFemaleFollow-Up StudiesFusion Proteins, bcr-ablHumansImatinib MesylateKaplan-Meier EstimateLeukemia, Myeloid, Chronic-PhaseMaleAniline CompoundsAntineoplastic AgentsBCR-ABL1 fusion protein, humanbosutinibFusion Proteins, bcr-ablImatinib MesylateNitrilesQuinolinesbosutinibchronic myeloid leukaemiasecond-line therapytyrosine kinase inhibitor

Identifiers

PMID26537529
PMCPMC4737299
OpenAlexW1919069136

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.