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Clinical Chemistry 48: 1314-1320, 2002;
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(Clinical Chemistry. 2002;48:1314-1320.)
© 2002 American Association for Clinical Chemistry, Inc.

Relationship of Serum HER-2/neu and Serum CA 15-3 in Patients with Metastatic Breast Cancer

Suhail M. Ali1,2, Kim Leitzel1, Vernon M. Chinchilli1, Linda Engle1, Laurence Demers1, Harold A. Harvey1, Walter Carney3, Jeffrey W. Allard3 and Allan Lipton1a

1 The M.S. Hershey Medical Center, Hershey, PA 17033.

2 Veterans Administration Medical Center, Lebanon, PA 17042.

3 Bayer Corporation, Tarrytown, NY 10591.

aAddress correspondence to this author at: The M.S. Hershey Medical Center, Department of Medicine, Division of Hematology/Oncology HO46, 500 University Dr., PO Box 850, Hershey, PA 17033.

Background: Serum HER-2/neu antigen concentrations have been reported to correlate with increased tumor volume in patients with breast cancer. We measured serum CA 15-3, a surrogate marker of disease burden, and correlated serum CA 15-3 with serum HER-2/neu and analyzed the association of both markers with clinical outcomes.

Methods: Pretreatment serum samples from 566 patients were retrospectively analyzed from 2 phase III clinical trials of estrogen receptor-positive (ER+), ER-/progesterone receptor-positive, or ER status unknown metastatic breast cancer patients randomized in two similar studies to receive second-line hormone therapy with either megestrol acetate or an aromatase inhibitor (fadrozole). The extracellular domain of the HER-2/neu (c-erbB-2) oncogene and serum CA 15-3 were measured by ELISA on the Bayer Immuno 1.

Results: Serum HER-2/neu protein was increased in 168 patients (30%), and CA 15-3 was increased in 337 (60%) patients. Serum CA 15-3 and HER-2/neu were weakly correlated (r = 0.39; P <0.0001). The clinical benefit (complete responses plus partial responses plus stable disease) of endocrine therapy was significantly lower in patients with increased serum HER-2/neu. When adjusted for serum HER-2/neu, serum CA 15-3 was not predictive of response rates. The median time to progression was shorter in patients with increased serum HER-2/neu (89 days) compared with patients with normal serum HER-2/neu (176 days). Survival was significantly shorter in patients with increased serum HER-2/neu (513 vs 869 days; P <0.0001) or increased serum CA 15-3 (689 vs 939 days; P <0.0001). This observation was confirmed by multivariate analysis.

Conclusions: Serum HER-2/neu is a significant independent predictive and prognostic factor in hormone receptor-positive metastatic breast cancer, even when adjusted for tumor burden as measured by CA 15-3. The combination of increased serum HER-2/neu and increased serum CA 15-3 predicts a worse prognosis than does increased CA 15-3 alone.




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