Evidence map›Paper›PMID 22315057›Full record

ArticleBritish journal of cancer2012

A phase 1 trial of recombinant human IL-21 in combination with cetuximab in patients with metastatic colorectal cancer.

N Steele, A Anthony, M Saunders, B Esmarck, E Ehrnrooth, P E G Kristjansen, A Nihlén, L T Hansen, J Cassidy

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

Article in British journal of cancer, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 46 papers.

0numbers the graph read from it
0cells of the map it votes in
46citing papers in PubMed
3.4field-weighted citation impact, top 8% 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

46 citing papers in PubMed, 88 citations in OpenAlex.

  1. Article
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  8. From bench to bedside: the past, present and future of IL-21 immunotherapy.Medical oncology (Northwood, London, England) · 2024
    Review
  9. Article
  10. Review
  11. NK cell-based tumor immunotherapy.Bioactive materials · 2024
    Review
  12. Implications of IL-21 in solid tumor therapy.Medical oncology (Northwood, London, England) · 2023
    Review
  13. Review
  14. Review
  15. Review
  16. Article
  17. Review
  18. Natural killer cells: a promising immunotherapy for cancer.Journal of translational medicine · 2022
    Review
  19. 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

9 authors at 3 institutions in 2 countries.

N SteeleCRUK Clinical Trials Unit, Beatson West of Scotland Cancer Centre, 1053 Great Western Road, Glasgow G12 0YN, UK. n.steele@nhs.net
A Anthony
M Saunders
B Esmarck
E Ehrnrooth
P E G Kristjansen
A Nihlén
L T Hansen
J Cassidy
Novo Nordisk (Denmark) · DKBeatson West of Scotland Cancer Centre · GBThe Christie Hospital · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPre-clinical data indicate enhanced anti-tumour activity when combining recombinant human interleukin-21 (rIL-21), a class 1 cytokine, with cetuximab, a monoclonal antibody, targeting the epidermal growth factor receptor. This phase 1 trial assessed the safety and tolerability of escalating doses of rIL-21 in combination with cetuximab in chemo-naïve patients with stage IV colorectal cancer. PATIENTS AND

methodsSequential cohorts of PS 0-1, asymptomatic patients, were treated weekly with cetuximab 250 mg m(-2) intravenously (i.v.) plus escalating i.v. doses of rIL-21 following an initial loading dose of cetuximab 400 mg m(-2). Initial treatment period was 8 weeks, with extension permitted in patients without disease progression.

resultsIn all, 15 patients were included in this study. Adverse events related to rIL-21 or rIL-21 plus cetuximab included lethargy, nausea/vomiting, stomatitis, lymphopenia and pyrexia and were mainly ≤ grade 2. One dose limiting toxicity occurred (grade 3 diarrhoea). Maximum tolerated dose was not determined because of the premature study closure. Maximum administered dose was 100 μg kg(-1) rIL-21 weekly. In all, 60% of the patients had stable disease. Immune activation was confirmed by various T- and NK-cell activation biomarkers, including dose-dependent increases in serum sCD25.

conclusionrIL-21 weekly combined with cetuximab is well tolerated at doses up to 100 μg kg(-1) and results in activation of immune response biomarkers.

Indexed as

AdultAgedAged, 80 and overAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsCetuximabColorectal NeoplasmsErbB ReceptorsFemaleHumansInterleukin-21InterleukinsMaleMaximum Tolerated DoseAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic AgentsCetuximabErbB ReceptorsInterleukin-21Interleukins

Identifiers

PMID22315057
PMCPMC3305963
OpenAlexW2075832844

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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.