BACKGROUND, CA 15-3 is a breast-associated mucin that is elevated in the ma
jority of breast carcinoma patients with distant metastases. Currently, the
main application of this marker is in monitoring and detecting recurrences
in patients with diagnosed breast carcinoma.
METHODS. Preoperative serum concentrations (prior to excision of the primar
y tumor) of CA 15-3 were measured in 368 patients undergoing potentially cu
rative surgical treatment for early breast carcinoma. These results were co
mpared with prospectively recorded clinicopathologic characteristics and pa
tient outcome data.
RESULTS. A weak but significant positive association was found between CA 1
5-3 concentrations and both tumor stage and the number of involved axillary
lymph nodes but not between CA 15-3 concentrations and estrogen receptor s
tatus. Patients with high concentrations of CA 15-3 had a significantly wor
se prognosis than patients with low concentrations. Using an optimum cutoff
value of 30.38 U/mL, the probability of disease free survival at 5 years w
as 44% in patients with high CA 15-3 levels compared with 65% in patients w
ith low CA 15-3 levels (P = 0.002, Mantel-Cox log rank test). The correspon
ding probabilities for overall survival were 67% and 83%, respectively (P <
0.001). The association of preoperative CA 15-3 levels with outcome was ma
intained in multivariate survival analysis and was not explained by the ass
ociation between CA 15-3 and tumor size or lymph node burden. The relation
between CA 15-3 and outcome also was found within some patient subgroups id
entified by traditional prognostic factors (axillary lymph node positive pa
tients, patients with primary tumors >2 cm in greatest dimension, and patie
nts with estrogen receptor positive tumors).
CONCLUSIONS, Preoperative serum concentrations of CA 15-3 appear to have a
significant relation to outcome in patients with early breast carcinoma and
may have a role in the rational selection of patients for appropriate adju
vant treatments. To the authors' knowledge, CA 15-3 thus is one of the firs
t circulating markers shown to be an independent prognostic indicator in pa
tients with breast carcinoma. Cancer 1998;83:2521-7. (C) 1998 American Canc
er Society.