Evidence map›Paper›PMID 26040495›Full record

Trial reportAmerican journal of hematology2015

Long-term efficacy and safety of bosutinib in patients with advanced leukemia following resistance/intolerance to imatinib and other tyrosine kinase inhibitors.

Carlo Gambacorti-Passerini, Hagop M Kantarjian, Dong-Wook Kim, Hanna J Khoury, Anna G Turkina, Tim H Brümmendorf, Ewa Matczak, Nathalie Bardy-Bouxin, Mark Shapiro, Kathleen Turnbull and 2 more

Abstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in American journal of hematology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 35 papers.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

35 citing papers in PubMed.

  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. Review
  6. Review
  7. Article
  8. Boosting synergism of chemo- and immuno-therapiesActa pharmaceutica Sinica. B · 2024
    Article
  9. Review
  10. Review
  11. Article
  12. Review
  13. Blast and accelerated phase CML: room for improvement.Hematology. American Society of Hematology. Education Program · 2021
    Article
  14. Article
  15. Article
  16. Review
  17. Review
  18. Review
  19. Article
  20. Review
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.

Carlo Gambacorti-PasseriniDepartment of Internal Medicine, University of Milano-Bicocca, Monza, Italy.
Hagop M KantarjianDepartment of Leukemia, Division of Cancer Medicine, University of Texas MD Anderson Cancer Center, Houston, Texas.
Dong-Wook KimDepartment of Hematology, Seoul St. Mary's Hospital, Seoul, South Korea.
Hanna J KhouryDivision of Hematology, Winship Cancer Institute of Emory University, Atlanta, Georgia.
Anna G TurkinaHematology Research Center, Moscow, Russia.
Tim H BrümmendorfClinic for Oncology, Hematology, and Stem Cell Transplantation, Universitätsklinikum Aachen, RWTH Aachen, Germany.
Ewa MatczakPfizer, New York, New York.
Nathalie Bardy-BouxinPfizer Global Research and Development, Paris, France.
Mark ShapiroPfizer, Cambridge, Massachusetts.
Kathleen TurnbullPfizer, Cambridge, Massachusetts.
Eric LeipPfizer, Cambridge, Massachusetts.
Jorge E CortesDepartment of Leukemia, Division of Cancer Medicine, University of Texas MD Anderson Cancer Center, Houston, Texas.

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Fabien Delerue · 1985 to 2026
$290.8M
TOLERANCE INDUCTION BY MEGADOSE STEM CELL TRANSPLANTS IN CML--GVHD AND GVLP01CA049639 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI SHPALL, ELIZABETH J · 1990 to 2014
$41.8M
NCI NIH HHS P01 CA049639NCI NIH HHS P30 CA016672
6 · The paper itself

Abstract

Long-term efficacy and safety of bosutinib (≥4 years follow-up from last enrolled patient) were evaluated in an ongoing phase 1/2 study in the advanced leukemia cohort with prior treatment failure (accelerated-phase [AP, n = 79] chronic myeloid leukemia [CML], blast-phase [BP, n = 64] CML, acute lymphoblastic leukemia [ALL, n = 24]). Fourteen AP, 2 BP, and 1 ALL patient remained on bosutinib at 4 years (vs. 38, 8, 1 at 1 year); median (range) treatment durations: 10.2 (0.1-88.6), 2.8 (0.03-55.9), 0.97 (0.3-89.2) months. Among AP and BP patients, 57% and 28% newly attained or maintained baseline overall hematologic response (OHR); 40% and 37% attained/maintained major cytogenetic response (MCyR) by 4 years (most by 12 months). In responders at 1 versus 4 years, Kaplan-Meier (KM) probabilities of maintaining OHR were 78% versus 49% (AP) and 28% versus 19% (BP); KM probabilities of maintaining MCyR were 65% versus 49% (AP) and 21% versus 21% (BP). Most common AEs (AP, BP) were gastrointestinal (96%; 83%), primarily diarrhea (85%; 64%), which was typically low grade (maximum grade 1/2: 81%; 59%) and transient; no patient discontinued due to diarrhea. Serious AEs occurred in 44 (56%) AP and 37 (58%) BP patients, most commonly pneumonia (n = 9) for AP and pyrexia (n = 6) for BP; 11 and 13 died within 30 days of last dose (2 considered bosutinib-related [AP] per investigator). Responses were durable in ∼50% AP responders at 4 years (∼25% BP patients responded at year 1, suggesting possible bridge-to-transplant role in BP patients); toxicity was manageable.

Indexed as

AdolescentAdultAgedAged, 80 and overAniline CompoundsAntineoplastic AgentsBenzamidesBlast CrisisDiarrheaDrug Resistance, NeoplasmFemaleFeverFollow-Up StudiesHumansImatinib MesylateMaleAniline CompoundsAntineoplastic AgentsBenzamidesbosutinibImatinib MesylateNitrilesPiperazinesProtein Kinase InhibitorsPyrimidinesQuinolines

Identifiers

PMID26040495
PMCPMC5132035

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

None linked

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.