Evidence map›Paper›PMID 18060404›Full record

Trial reportCancer immunology, immunotherapy : CII2008

Vaccination of colorectal cancer patients with TroVax given alongside chemotherapy (5-fluorouracil, leukovorin and irinotecan) is safe and induces potent immune responses.

Richard Harrop, Noel Drury, William Shingler, Priscilla Chikoti, Irina Redchenko, Miles W Carroll, Susan M Kingsman, Stuart Naylor, Richard Griffiths, Neil Steven and 1 more

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

Trial report in Cancer immunology, immunotherapy : CII, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 34 papers.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed
2.5field-weighted citation impact, top 10% 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

34 citing papers in PubMed, 85 citations in OpenAlex.

  1. Trial
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  4. Review
  5. Article
  6. Review
  7. Article
  8. Review
  9. Article
  10. Review
  11. Article
  12. TroVax in colorectal cancer.Human vaccines & immunotherapeutics · 2014
    Review
  13. Immunological off-target effects of standard treatments in gastrointestinal cancers.Annals of oncology : official journal of the European Society for Medical Oncology · 2014
    Review
  14. Review
  15. Article
  16. Article
  17. Article
  18. Review
  19. Review
  20. Therapeutic vaccines for gastrointestinal cancers.Gastroenterology & hepatology · 2011
    Article
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 at 4 institutions in 2 countries.

Richard HarropOxford BioMedica (UK) Ltd, The Medawar Centre, Oxford Science Park, Oxford OX4 4GA, UK. r.harrop@oxfordbiomedica.co.uk
Noel Drury
William Shingler
Priscilla Chikoti
Irina Redchenko
Miles W Carroll
Susan M Kingsman
Stuart Naylor
Richard Griffiths
Neil Steven
Robert E Hawkins
College Station Medical Center · USOxford BioMedica (United Kingdom) · GBThe Christie Hospital · GBQueen Elizabeth Hospital Birmingham · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Modified vaccinia Ankara (MVA) encoding the tumor antigen 5T4 (TroVax) has been evaluated in an open label phase II study in metastatic colorectal cancer patients. The primary objective was to assess the safety and immunogenicity of TroVax injected before, during and after treatment with 5-fluorouracil, leukovorin and irinotecan. TroVax was administered to 19 patients with metastatic colorectal cancer. Twelve patients had blood samples taken following each of the six injections and were considered to be evaluable for assessment of immunological responses. Both antibody and cellular responses specific for the tumor antigen 5T4 and the viral vector MVA were monitored throughout the study. Administration of TroVax alongside chemotherapy was safe and well tolerated with no SAEs attributed to the vaccine and no enhancement of chemo-related toxicity. Of the 12 patients who were evaluable for assessment of immune responses, ten mounted 5T4-specific antibody responses with titers ranging from 10 to > 5,000. IFNgamma ELISPOT responses specific for 5T4 were detected in 11 patients with frequencies exceeding one in 1,000 PBMCs in five patients. Eight patients presented with elevated circulating CEA concentrations, six of whom showed decreases in excess of 50% during chemotherapy and four had CEA levels which remained stable for > 1 month following completion of chemotherapy. Of the 19 intention to treat (ITT) patients, one had a CR, six had PRs and five had SD. Potent 5T4-specific cellular and/or humoral immune responses were induced in all 12 evaluable patients and were detectable in most patients during the period in which chemotherapy was administered. These data demonstrate that TroVax can be layered on top of chemotherapy regimens without any evidence of enhanced toxicity or reduced immunological or therapeutic efficacy.

Indexed as

AgedAntineoplastic Combined Chemotherapy ProtocolsCamptothecinCancer VaccinesColorectal NeoplasmsCombined Modality TherapyFemaleFluorouracilHumansImmunotherapyIrinotecanLeucovorinMaleMiddle AgedVaccines, DNACamptothecinCancer VaccinesFluorouracilIrinotecanLeucovorinTroVaxVaccines, DNA

Identifiers

PMID18060404
PMCPMC11029980
OpenAlexW1978767079

What OpenQuestion holds

Textmetadata
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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.