BACKGROUND, Recently, the extracellular domain of the c-erbB-2 oncogen
e product (HER-2/neu) has been reported to be elevated in the serum of
one-fourth of patients with metastatic breast carcinoma. The role of
serum c-erbB-2 as a tumor marker, however, is still poorly defined. Th
e purpose of this study was to evaluate the utility of serial serum c-
erbB-2 levels as a tumor marker in patients with metastatic breast car
cinoma. METHODS, c-erbB-2 levels in the sera of patients with breast c
arcinoma were determined by an enzyme immunoassay that detects the ext
racellular domain of c-erbB-2. Serum c-erbB-2 levels were evaluated pr
ior to treatment as well as throughout the course of treatment with se
cond-line hormonal therapy employing either megestrol acetate or fadro
zole, an experimental aromatase inhibitor. RESULTS, Fifty-eight of 300
patients (19.3%) had elevated pretreatment serum c-erbB-2 levels. Of
these 58 patients with elevated pretreatment c-erbB-2, 48 had more tha
n 1 visit which enabled us to quantitate serial c-erbB-2 levels throug
hout the course of treatment. Of these 48 patients, 28 (58.3%) had ser
ial c-erbB-2 values that correlated with the clinical course. CONCLUSI
ONS, Serial serum c-erbB-2 levels did not show a high overall correlat
ion with the clinical course in this group of patients with metastatic
breast carcinoma treated with second-line hormonal therapy. (C) 1996
American Cancer Society.