Evidence map›Paper›PMID 16776849›Full record

Trial reportBreast cancer research : BCR2006

Pilot phase III immunotherapy study in early-stage breast cancer patients using oxidized mannan-MUC1 [ISRCTN71711835].

Vasso Apostolopoulos, Geoffrey A Pietersz, Anastasios Tsibanis, Annivas Tsikkinis, Heleni Drakaki, Bruce E Loveland, Sara J Piddlesden, Magdalena Plebanski, Dodie S Pouniotis, Michael N Alexis and 2 more

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

Trial report in Breast cancer research : BCR, 2006. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 62 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
62citing papers in PubMed, 1 pooled it
5.3field-weighted citation impact, top 4% 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

62 citing papers in PubMed, 1 synthesis or guideline pooled it, 172 citations in OpenAlex.

  1. Pooled it
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  10. Stereoselective Synthesis of Sialyl LewisAngewandte Chemie (International ed. in English) · 2023
    Article
  11. mRNA vaccination in breast cancer: current progress and future direction.Journal of cancer research and clinical oncology · 2023
    Review
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2 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

12 authors at 3 institutions in 2 countries.

Vasso ApostolopoulosImmunology and Vaccine Laboratory, Burnet Institute at Austin, Heidelberg, Victoria, Australia. vasso@burnet.edu.au
Geoffrey A Pietersz
Anastasios Tsibanis
Annivas Tsikkinis
Heleni Drakaki
Bruce E Loveland
Sara J Piddlesden
Magdalena Plebanski
Dodie S Pouniotis
Michael N Alexis
Ian F McKenzie
Stamatis Vassilaros
Burnet Institute · AUAthens Medical Center · GRNational Hellenic Research Foundation · GR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionMucin 1 (MUC1) is a high molecular weight glycoprotein overexpressed on adenocarcinoma cells and is a target for immunotherapy protocols. To date, clinical trials against MUC1 have included advanced cancer patients. Herein, we report a trial using early stage breast cancer patients and injection of oxidized mannan-MUC1.

methodIn a randomized, double-blind study, 31 patients with stage II breast cancer and with no evidence of disease received subcutaneous injections of either placebo or oxidized mannan-MUC1, to immunize against MUC1 and prevent cancer reoccurrence/metastases. Twenty-eight patients received the full course of injections of either oxidized mannan-MUC1 or placebo. Survival and immunological assays were assessed.

resultsAfter more than 5.5 years had elapsed since the last patient began treatment (8.5 years from the start of treatment of the first patient), the recurrence rate in patients receiving the placebo was 27% (4/15; the expected rate of recurrence in stage II breast cancer); those receiving immunotherapy had no recurrences (0/16), and this finding was statistically significant (P = 0.0292). Of the patients receiving oxidized mannan-MUC1, nine out of 13 had measurable antibodies to MUC1 and four out of 10 had MUC1-specific T cell responses; none of the placebo-treated patients exhibited an immune response to MUC1.

conclusionThe results suggest that, in early breast cancer, MUC1 immunotherapy is beneficial, and that a larger phase III study should be undertaken.

Indexed as

AdenocarcinomaAgedAged, 80 and overAntibody FormationBreast NeoplasmsDouble-Blind MethodFemaleHumansImmunotherapyMannansMiddle AgedMucin-1MannansMucin-1

Identifiers

PMID16776849
PMCPMC1557739
OpenAlexW2146674901

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.