Evidence map›Paper›PMID 26867764›Full record

Trial reportBMC cancer2016

A phase II study of Epirubicin in oxaliplatin-resistant patients with metastatic colorectal cancer and TOP2A gene amplification.

Line S Tarpgaard, Camilla Qvortrup, Sune B Nygård, Signe L Nielsen, Diana R Andersen, Niels Frank Jensen, Jan Stenvang, Sönke Detlefsen, Nils Brünner, Per Pfeiffer

Open access · goldAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in BMC cancer, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed
1.9field-weighted citation impact, top 13% 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

22 citing papers in PubMed, 38 citations in OpenAlex.

  1. Article
  2. Proteo-genomic characterization of cirrhosis-associated liver cancers reveals potential subtypes and therapeutic targets.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2024
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  17. AOncology letters · 2018
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  18. [Identification of key pathways and drug repurposing for anaplastic thyroid carcinoma by integrated bioinformatics analysis].Zhejiang da xue xue bao. Yi xue ban = Journal of Zhejiang University. Medical sciences · 2018
    Article
  19. Identifying a Novel BiomarkerJournal of Cancer · 2018
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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

10 authors at 2 institutions in 1 country.

Line S TarpgaardDepartment of Oncology, Odense University Hospital, Odense, Denmark. line.tarpgaard@rsyd.dk.
Camilla QvortrupDepartment of Oncology, Odense University Hospital, Odense, Denmark. camilla.qvortrup@rsyd.dk.
Sune B NygårdFaculty of Health and Medical Sciences, Department of Veterinary Disease Biology, University of Copenhagen, Frederiksberg, Denmark. Sune.Boris.Nygaard@regionh.dk.
Signe L NielsenFaculty of Health and Medical Sciences, Department of Veterinary Disease Biology, University of Copenhagen, Frederiksberg, Denmark. siln@sund.ku.dk.
Diana R AndersenDepartment of Oncology, Odense University Hospital, Odense, Denmark. diana.riise.andersen@rsyd.dk.
Niels Frank JensenFaculty of Health and Medical Sciences, Department of Veterinary Disease Biology, University of Copenhagen, Frederiksberg, Denmark. tfm434@alumni.ku.dk.
Jan StenvangFaculty of Health and Medical Sciences, Department of Veterinary Disease Biology, University of Copenhagen, Frederiksberg, Denmark. stenvang@sund.ku.dk.
Sönke DetlefsenDepartment of Pathology, Odense University Hospital, Odense, Denmark. sonke.detlefsen@rsyd.dk.
Nils BrünnerFaculty of Health and Medical Sciences, Department of Veterinary Disease Biology, University of Copenhagen, Frederiksberg, Denmark. nbr@sund.ku.dk.
Per PfeifferDepartment of Oncology, Odense University Hospital, Odense, Denmark. per.pfeiffer@rsyd.dk.
Odense University Hospital · DKUniversity of Copenhagen · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

unlabelledThe overall purpose of this study is to provide proof of concept for introducing the anthracycline epirubicin as an effective, biomarker-guided treatment for metastatic colorectal cancer (mCRC) patients who are refractory to treatment with oxaliplatin-based chemotherapy and have TOP2A gene amplification in their tumor cells.

backgroundEpirubicin is an anthracycline that targets DNA topoisomerase 2-α enzyme encoded by the TOP2A gene. It is used for treatment of several malignancies, but currently not in CRC. TOP2A gene amplifications predict improved efficacy of epirubicin in patients with breast cancer and thus could be an alternative option for patients with CRC and amplified TOP2A gene. We have previously analysed the frequency of TOP2A gene aberrations in CRC and found that 46.6% of these tumors had TOP2A copy gain and 2.0% had loss of TOP2A when compared to adjacent normal tissue. The TOP2A gene is located on chromosome 17 and when the TOP2A/CEN-17 ratio was applied to identify tumors with gene loss or amplifications, 10.5% had a ratio ≥ 1.5 consistent with gene amplification and 2.6% had a ratio ≤ 0.8 suggesting gene deletions. Based on these observations and the knowledge gained from treatment of breast cancer patients, we have initiated a prospective clinical, phase II protocol using epirubicin (90 mg/m2 iv q 3 weeks) in mCRC patients, who are refractory to treatment with oxaliplatin. METHODS/

designThe study is an open label, single arm, phase II study, investigating the efficacy of epirubicin in patients with oxaliplatin refractory mCRC and with a cancer cell TOP2A/CEN-17 ratio ≥ 1.5. TOP2A gene amplification measured by fluorescence in situ hybridization. A total of 25 evaluable patients (15 + 10 in two steps) will be included (Simon's two-stage minimax design). Every nine weeks, response is measured by computed tomography imaging and evaluated according to RECIST 1.1. The primary end-point of the study is progression-free survival.

trial registrationEudract no. 2013-001648-79.

Indexed as

PrognosisAdultAntigens, NeoplasmColorectal NeoplasmsDisease-Free SurvivalDNA-Binding ProteinsDNA Topoisomerases, Type IIEpirubicinFemaleGene AmplificationHumansIn Situ Hybridization, FluorescenceMaleMiddle AgedOrganoplatinum CompoundsOxaliplatinAntigens, NeoplasmDNA-Binding ProteinsDNA Topoisomerases, Type IIEpirubicinOrganoplatinum CompoundsOxaliplatinPoly-ADP-Ribose Binding ProteinsTOP2A protein, human

Identifiers

PMID26867764
PMCPMC4750171
OpenAlexW2261106146

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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.