Evidence map›Paper›PMID 24043741›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2014

Phase II study of alisertib, a selective Aurora A kinase inhibitor, in relapsed and refractory aggressive B- and T-cell non-Hodgkin lymphomas.

Jonathan W Friedberg, Daruka Mahadevan, Erin Cebula, Daniel Persky, Izidore Lossos, Amit B Agarwal, Jungah Jung, Richard Burack, Xiaofei Zhou, E Jane Leonard and 3 more

Open access · bronzeAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 113 papers.

0numbers the graph read from it
0cells of the map it votes in
113citing papers in PubMed
17.6field-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.

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

113 citing papers in PubMed, 208 citations in OpenAlex.

  1. Trial
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  8. Phase II Intergroup Trial of Alisertib in Relapsed and Refractory Peripheral T-Cell Lymphoma and Transformed Mycosis Fungoides: SWOG 1108.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2015
    Trial
  9. Article
  10. Article
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  12. Clinical analysis of 10 cases with subcutaneous panniculitis-like T-cell lymphoma and tissue AURKA expression.Skin research and technology : official journal of International Society for Bioengineering and the Skin (ISBS) [and] International Society for Digital Imaging of Skin (ISDIS) [and] International Society for Skin Imaging (ISSI) · 2024
    Article
  13. Article
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  15. Review
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  18. The two sides of chromosomal instability: drivers and brakes in cancer.Signal transduction and targeted therapy · 2024
    Review
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  20. Article

53 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 1 institution in 1 country.

Jonathan W FriedbergJonathan W. Friedberg, Erin Cebula, Richard Burack, and Steven H. Bernstein, University of Rochester Wilmot Cancer Center, Rochester, NY; Daruka Mahadevan, West Clinic and University of Tennessee Health Sciences Center, Memphis, TN; Daniel Persky, Yale University, New Haven, CT; Izidore Lossos, Sylvester Comprehensive Cancer Center, University of Miami, Miami, FL; Amit G. Agarwal, University of Arizona Cancer Center, Tucson, AZ; and JungAh Jung, Xiaofei Zhou, E. Jane Leonard, Howard Fingert, and Hadi Danaee, Millennium Pharmaceuticals, Cambridge, MA.
Daruka Mahadevan
Erin Cebula
Daniel Persky
Izidore Lossos
Amit B Agarwal
Jungah Jung
Richard Burack
Xiaofei Zhou
E Jane Leonard
Howard Fingert
Hadi Danaee
Steven H Bernstein
Sylvester Comprehensive Cancer Center · US

Funding

SPORE in LymphomaP50CA130805 · NCI · UNIVERSITY OF ROCHESTER · PI BERNSTEIN, STEVEN H · 2008 to 2012
$11.7M
NCI NIH HHS CA-130805NCI NIH HHS P50 CA130805
6 · The paper itself

Abstract

purposeAurora A kinase (AAK) is overexpressed in aggressive lymphomas and can correlate with more histologically aggressive forms of disease. We therefore designed a phase II study of alisertib, a selective AAK inhibitor, in patients with relapsed and refractory aggressive non-Hodgkin lymphomas. PATIENTS AND

methodsPatients age ≥ 18 years were eligible if they had relapsed or refractory diffuse large B-cell lymphoma (DLBCL), mantle-cell lymphoma (MCL), transformed follicular lymphoma, Burkitt's lymphoma, or noncutaneous T-cell lymphoma. Alisertib was administered orally at 50 mg twice daily for 7 days in 21-day cycles.

resultsWe enrolled 48 patients. Histologies included DLBCL (n = 21), MCL (n = 13), peripheral T-cell lymphoma (n = 8), transformed follicular lymphoma (n = 5), and Burkitt's (n = 1). Most common grade 3 to 4 adverse events were neutropenia (63%), leukopenia (54%), anemia (35%), thrombocytopenia (33%), stomatitis (15%), febrile neutropenia (13%), and fatigue (6%). Four deaths during the study were attributed to progressive non-Hodgkin lymphoma (n = 2), treatment-related sepsis (n = 1), and unknown cause (n = 1). The overall response rate was 27%, including responses in three of 21 patients with DLBCL, three of 13 with MCL, one of one with Burkitt's lymphoma, two of five with transformed follicular lymphoma, and four of eight with noncutaneous T-cell lymphoma. The alisertib steady-state trough concentration (n = 25) revealed the expected pharmacokinetic variability, with a trend for higher incidence of adverse event-related dose reductions at higher trough concentrations. Analysis for AAK gene amplification and total AAK protein revealed no differences between histologies or correlation with clinical response.

conclusionThe novel AAK inhibitor alisertib seems clinically active in both B- and T-cell aggressive lymphomas. On the basis of these results, confirmatory single-agent and combination studies have been initiated.

Indexed as

AdultAgedAntineoplastic AgentsAurora Kinase AAzepinesBurkitt LymphomaDrug Administration ScheduleFemaleHumansLymphoma, FollicularLymphoma, Large B-Cell, DiffuseLymphoma, Mantle-CellLymphoma, T-CellMaleMiddle AgedMolecular Targeted TherapyAntineoplastic AgentsAurora Kinase AAzepinesMLN 8237Protein Kinase InhibitorsPyrimidines

Identifiers

PMID24043741
PMCPMC3867644
OpenAlexW2171285924

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.