Evidence map›Paper›PMID 30707661›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2019

Randomized Phase III Study of Alisertib or Investigator's Choice (Selected Single Agent) in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma.

Owen A O'Connor, Muhit Özcan, Eric D Jacobsen, Josep M Roncero, Judith Trotman, Judit Demeter, Tamás Masszi, Juliana Pereira, Radhakrishnan Ramchandren, Anne Beaven and 20 more

Open access · hybridAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 99 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
99citing papers in PubMed, 3 pooled it
11.1field-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

99 citing papers in PubMed, 3 syntheses or guidelines pooled it, 145 citations in OpenAlex.

  1. Pooled it
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  13. Aurora-A drives sorafenib resistance by scaffolding stress granule assembly via phase separation.Proceedings of the National Academy of Sciences of the United States of America · 2026
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39 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

30 authors at 20 institutions in 10 countries.

Owen A O'Connor1 Columbia University Medical Center, New York, NY.
Muhit Özcan2 Ankara University Medical School, Ankara, Turkey.
Eric D Jacobsen3 Dana-Farber Cancer Institute, Boston, MA.
Josep M Roncero4 Institut Català d'Oncologia de Girona, Girona, Spain.
Judith Trotman5 Concord Repatriation General Hospital, Concord, New South Wales, Australia.
Judit Demeter7 Semmelweis Egyetem Általános Orvostudományi Kar, Budapest, Hungary.
Tamás Masszi8 St. István and St. László Hospital, Budapest, Hungary.
Juliana Pereira10 Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.
Radhakrishnan Ramchandren11 Karmanos Cancer Institute, Detroit, MI.
Anne Beaven12 Duke University Health System, Durham, NC.
Dolores Caballero13 Hospital Universitario de Salamanca, Salamanca, Spain.
Steven M Horwitz14 Memorial Sloan Kettering Cancer Center, New York, NY.
Anne Lennard15 Northern Centre for Cancer Care, Newcastle upon Tyne, United Kingdom.
Mehmet Turgut16 Ondokuz Mayis University, Samsun, Turkey.
Nelson Hamerschlak17 Hospital Israelita Albert Einstein, Sao Paulo, Brazil.
Francesco A d'Amore18 Aarhus Universitetshospital, Aarhus, Denmark.
Francine Foss19 Smilow Cancer Hospital at Yale New Haven, New Haven, CT.
Won-Seog Kim20 Sungkyunkwan University School of Medicine, Seoul, South Korea.
John P Leonard21 Weill Cornell Medical College, New York, NY.
Pier Luigi Zinzani22 University of Bologna, Bologna, Italy.
Carlos S Chiattone23 Santa Casa Medical School, São Paulo, Brazil.
Eric D Hsi24 Cleveland Clinic, Cleveland, OH.
Lorenz Trümper25 University Medical Center Göttingen, Göttingen, Germany.
Hua Liu26 Millennium Pharmaceuticals, Cambridge, MA.
Emily Sheldon-Waniga26 Millennium Pharmaceuticals, Cambridge, MA.
Claudio Dansky Ullmann26 Millennium Pharmaceuticals, Cambridge, MA.
Karthik Venkatakrishnan26 Millennium Pharmaceuticals, Cambridge, MA.
E Jane Leonard26 Millennium Pharmaceuticals, Cambridge, MA.
Andrei R Shustov27 University of Washington, Seattle Cancer Care Alliance, Seattle, WA.
Lumiere Study Investigators
Millennium Engineering and Integration (United States) · USSemmelweis University · HUAarhus University · DKAnkara University · TRCleveland Clinic · USColumbia University Irving Medical Center · USComplejo Hospitalario de Salamanca · ESCornell University · USDana-Farber Cancer Institute · USDuke University Health System · USHospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo · BRHospital Israelita Albert Einstein · BRInstitut Català d'Oncologia · ESMemorial Sloan Kettering Cancer Center · USOndokuz Mayıs University · TRSeattle Cancer Care Alliance · USSmilow Cancer Hospital · USSungkyunkwan University · KRThe Barbara Ann Karmanos Cancer Institute · USUniversitätsmedizin Göttingen · DE

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

purposeThe aim of this open-label, first-in-setting, randomized phase III trial was to evaluate the efficacy of alisertib, an investigational Aurora A kinase inhibitor, in patients with relapsed/refractory peripheral T-cell lymphoma (PTCL). PATIENTS AND

methodsAdult patients with relapsed/refractory PTCL-one or more prior therapy-were randomly assigned 1:1 to receive oral alisertib 50 mg two times per day (days 1 to 7; 21-day cycle) or investigator-selected single-agent comparator, including intravenous pralatrexate 30 mg/m

resultsBetween May 2012 and October 2014, 271 patients were randomly assigned (alisertib, n = 138; comparator, n = 133). Enrollment was stopped early on the recommendation of the independent data monitoring committee as a result of the low probability of alisertib achieving PFS superiority with full enrollment. Centrally assessed overall response rate was 33% for alisertib and 45% for the comparator arm (odds ratio, 0.60; 95% CI, 0.33 to 1.08). Median PFS was 115 days for alisertib and 104 days for the comparator arm (hazard ratio, 0.87; 95% CI, 0.637 to 1.178). The most common adverse events were anemia (53% of alisertib-treated patients v 34% of comparator-treated patients) and neutropenia (47% v 31%, respectively). A lower percentage of patients who received alisertib (9%) compared with the comparator (14%) experienced events that led to study drug discontinuation. Of 26 on-study deaths, five were considered treatment related (alisertib, n = 3 of 11; comparator, n = 2 of 15). Two-year overall survival was 35% for each arm.

conclusionIn patients with relapsed/refractory PTCL, alisertib was not statistically significantly superior to the comparator arm.

Indexed as

AdultAgedAged, 80 and overAntineoplastic AgentsAurora Kinase AAzepinesDisease-Free SurvivalDisease ProgressionDrug Resistance, NeoplasmEarly Termination of Clinical TrialsFemaleHumansLymphoma, T-Cell, PeripheralMaleMiddle AgedProtein Kinase InhibitorsAntineoplastic AgentsAURKA protein, humanAurora Kinase AAzepinesMLN 8237Protein Kinase InhibitorsPyrimidines

Identifiers

PMID30707661
PMCPMC6494247
OpenAlexW2912527760

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.