Evidence map›Paper›PMID 27531525›Full record

Trial reportAmerican journal of hematology2016

Long-term bosutinib for chronic phase chronic myeloid leukemia after failure of imatinib plus dasatinib and/or nilotinib.

Jorge E Cortes, Hanna J Khoury, Hagop M Kantarjian, Jeff H Lipton, Dong-Wook Kim, Philippe Schafhausen, Ewa Matczak, Eric Leip, Kay Noonan, Tim H Brümmendorf and 1 more

Registry-linked trialAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in American journal of hematology, 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 53 papers.

0numbers the graph read from it
0cells of the map it votes in
53citing 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.

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

53 citing papers in PubMed.

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  10. 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
  11. Article
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  15. Evaluation of real-world versus clinical trial outcomes of tyrosine kinase inhibitor therapy for chronic myeloid leukemia.Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners · 2024
    Review
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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

11 authors.

Jorge E CortesUniversity of Texas MD Anderson Cancer Center, Houston, Texas.
Hanna J KhouryWinship Cancer Institute of Emory University, Atlanta, Georgia.
Hagop M KantarjianUniversity of Texas MD Anderson Cancer Center, Houston, Texas.
Jeff H LiptonPrincess Margaret Hospital, Toronto, Ontario.
Dong-Wook KimSeoul St. Mary's Hospital, Seoul, South Korea.
Philippe SchafhausenDepartment of Internal Medicine II, Hubertus Wald Tumor Center, University Cancer Center Hamburg, Hamburg, Germany.
Ewa MatczakPfizer Inc, New York, New York.
Eric LeipPfizer Inc, Cambridge, Massachusetts.
Kay NoonanPfizer Inc, Groton, Connecticut.
Tim H BrümmendorfDepartment of Internal Medicine II, Hubertus Wald Tumor Center, University Cancer Center Hamburg, Hamburg, Germany.
Carlo Gambacorti-PasseriniUniversity of Milano-Bicocca, Monza, Italy.

Funding

TOLERANCE INDUCTION BY MEGADOSE STEM CELL TRANSPLANTS IN CML--GVHD AND GVLP01CA049639 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI THALL, PETER F · 1990 to 2014
$41.8M
NCI NIH HHS P01 CA049639
6 · The paper itself

Abstract

Bosutinib is an Src/Abl tyrosine kinase inhibitor (TKI) indicated for adults with Ph+ chronic myeloid leukemia (CML) resistant/intolerant to prior TKIs. This long-term update of an ongoing phase 1/2 study evaluated the efficacy and safety of third-/fourth-line bosutinib in adults with chronic phase (CP) CML. Median durations of treatment and follow-up were 8.6 (range, 0.2-87.7) months and 32.7 (0.3-93.3) months, respectively. Cumulative confirmed complete hematologic response (cCHR) and major cytogenetic response (MCyR) rates were 74% (95% CI, 65-81%) and 40% (31-50%), respectively; Kaplan-Meier (K-M) probability of maintaining cCHR or MCyR at 4 years was 63% (95% CI, 50-73%) and 69% (52-81%). Cumulative incidence of on-treatment disease progression (PD)/death at 4 years was 24% (95% CI, 17-33%); K-M 4-year overall survival was 78% (68-85%). Baseline Ph+ cells ≤35 vs. ≥95% was prognostic of MCyR and CCyR by 3 and 6 months, increased baseline basophils was prognostic of PD/death, and no prior response to second-line TKI was prognostic of death. Common adverse events included diarrhea (83%), nausea (48%), vomiting (38%), and thrombocytopenia (39%). Bosutinib demonstrates durable efficacy and a toxicity profile similar to previous bosutinib studies in CP CML patients resistant/intolerant to multiple TKIs, representing an important treatment option for patients in this setting. This trial is registered at www.clinicaltrials.gov (NCT00261846). Am. J. Hematol. 91:1206-1214, 2016. © 2016 Wiley Periodicals, Inc.

Indexed as

AdolescentAdultAgedAged, 80 and overAniline CompoundsAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsDasatinibDisease ProgressionHumansImatinib MesylateLeukemia, Myeloid, Chronic-PhaseLongitudinal StudiesMiddle AgedNitrilesPyrimidinesAniline CompoundsAntineoplastic AgentsbosutinibDasatinibImatinib MesylatenilotinibNitrilesPyrimidinesQuinolines

Identifiers

PMID27531525
PMCPMC5303616

What OpenQuestion holds

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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.