Research article
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Pilot phase III immunotherapy study in early-stage breast cancer patients using oxidized mannan-MUC1 [ISRCTN71711835]
Vasso Apostolopoulos1 , Geoffrey A Pietersz1 , Anastasios Tsibanis2 , Annivas Tsikkinis2 , Heleni Drakaki2 , Bruce E Loveland1 , Sara J Piddlesden1 , Magdalena Plebanski1 , Dodie S Pouniotis1 , Michael N Alexis3 , Ian F McKenzie1 and Stamatis Vassilaros2
1Immunology and Vaccine Laboratory, Burnet Institute at Austin, Heidelberg, Victoria, Australia
2Prolipsis Medical Center, Athens, Greece
3Institute of Biological Research and Biotechnology, The National Hellenic Research Foundation, Athens, Greece
Breast Cancer Research 2006, 8:R27 doi:10.1186/bcr1505
The electronic version of this article is the complete one and can be found online at:
http://breast-cancer-research.com/content/8/3/R27
© 2006 Apostolopoulos et al.; licensee BioMed Central Ltd.
This is an open access article distributed under the terms of the Creative Commons Attribution License (
http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Mucin 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.
Method
In 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.
Results
After 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.
Conclusion
The results suggest that, in early breast cancer, MUC1 immunotherapy is beneficial, and that a larger phase III study should be undertaken.
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