Pilot phase III immunotherapy study in early-stage breast cancer patients using oxidized mannan-MUC1 [ISRCTN71711835]
2006

Immunotherapy Study in Early-Stage Breast Cancer Patients

Sample size: 31 publication Evidence: moderate

Author Information

Author(s): Apostolopoulos Vasso, Pietersz Geoffrey A, Tsibanis Anastasios, Tsikkinis Annivas, Drakaki Heleni, Loveland Bruce E, Piddlesden Sara J, Plebanski Magdalena, Pouniotis Dodie S, Alexis Michael N, McKenzie Ian F, Vassilaros Stamatis

Primary Institution: Burnet Institute at Austin, Heidelberg, Victoria, Australia

Hypothesis

Can immunotherapy using oxidized mannan-MUC1 prevent cancer recurrence in early-stage breast cancer patients?

Conclusion

The study suggests that MUC1 immunotherapy is beneficial in preventing recurrence in early breast cancer patients.

Supporting Evidence

  • Patients receiving immunotherapy had no recurrences after 5.5 years.
  • Four out of 15 patients receiving placebo had recurrences.
  • Nine out of 13 patients receiving immunotherapy developed antibodies to MUC1.

Takeaway

This study tested a new treatment for early breast cancer that helps prevent the cancer from coming back, and it worked well for the patients who received it.

Methodology

A randomized, double-blind study where 31 patients received either placebo or oxidized mannan-MUC1 injections.

Potential Biases

Potential bias due to the small number of participants and lack of a control group receiving only oxidized mannan.

Limitations

The study had a small sample size and was a pilot study.

Participant Demographics

Postmenopausal women aged 51-81 with stage II breast cancer.

Statistical Information

P-Value

0.0292

Statistical Significance

p<0.05

Digital Object Identifier (DOI)

10.1186/bcr1505

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