Use of Truquant BR radioimmunoassay for early detection of breast cancer recurrence in patients with stage II and stage III disease.

Abstract

PURPOSE:

The Truquant BR radioimmunoassay (RIA) (Biomira Diagnostics Inc, Rexdale, Canada) uses the monoclonal antibody B27.29 to quantitate the MUC-1 gene product (CA 27.29 antigen) in serum. We evaluated CA 27.29 antigen in a controlled, prospective clinical trial for its ability to predict relapse in stage II and stage III breast cancer patients.

PATIENTS AND METHODS:

Over a 2-year period, 166 patients who had completed therapy for stage II (80.1%) or III (19.9%) breast cancer and were clinically free of disease were serially tested for CA 27.29 antigen levels. The study was double-masked and cancer recurrence was documented based on clinical findings. Patients with two consecutive CA 27.29 antigen test results above the upper limit of normal were considered positive.

RESULTS:

The Truquant BR RIA had a sensitivity of 57.7%, specificity of 97.9%, positive predictive value of 83.3%, and negative predictive value of 92.6%. The recurrence rate was 15.7%. A Cox regression analysis showed that the only variable to correlate with recurrent disease was the CA 27.29 antigen test result. Patients with a positive test result had increased odds of having a recurrence (odds ratio, 6.8; P < .00001). The test was effective in predicting recurrence in patients with both distant and locoregional disease. In a subgroup of patients with bone pain, CA 27.29 antigen level was found to identify reliably patients who would subsequently develop recurrent disease.

CONCLUSION:

These data demonstrate that the Truquant BR RIA can be used as an aid to predict recurrent breast cancer in patients with stage II and III disease.

• Authors: D W Chan, R A Beveridge, H Muss, H A Fritsche, G Hortobagyi, R Theriault, D Kiang, B J Kennedy, M Evelegh
• Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology (J Clin Oncol) Vol. 15 Issue 6 Pg. 2322-8 (Jun 1997) ISSN: 0732-183X [Print] United States
• PMID: 9196146 (Publication Type: Clinical Trial, Controlled Clinical Trial, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Antigens, Tumor-Associated, Carbohydrate
• Biomarkers, Tumor
• CA 27-29 antigen

Topics

• Adult
• Aged
• Antigens, Tumor-Associated, Carbohydrate (blood)
• Biomarkers, Tumor (blood)
• Breast Neoplasms (blood, diagnosis, surgery)
• Double-Blind Method
• Female
• Humans
• Middle Aged
• Neoplasm Recurrence, Local (blood, diagnosis)
• Radioimmunoassay (methods)
• Reference Values
• Regression Analysis
• Sensitivity and Specificity