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Annals of Oncology Advance Access originally published online on January 10, 2008
Annals of Oncology 2008 19(5):883-890; doi:10.1093/annonc/mdm585
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© The Author 2008. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oxfordjournals.org

breast cancer

Evaluation of serum HER2 extracellular domain in early breast cancer patients: correlation with clinicopathological parameters and survival

V. Ludovini1,{dagger},*, S. Gori1,{dagger}, M. Colozza1, L. Pistola1, E. Rulli2, I. Floriani2, E. Pacifico3, F. R. Tofanetti1, A. Sidoni4, C. Basurto1, A. Rulli5 and L. Crinò1

1 Medical Oncology Division, Azienda Ospedaliera of Perugia, Perugia
2 Department of Oncology, Istituto di Ricerche Farmacologiche ‘Mario Negri’, Milan
3 Biochemistry and Clinical Chemistry Laboratory, Azienda Ospedaliera of Perugia, Perugia
4 Institute of Pathology
5 ‘Breast Unit’, Department of Surgical, University of Perugia, Perugia, Italy

* Correspondence to: Dr V. Ludovini, Medical Oncology Division, Azienda Ospedaliera of Perugia, via Brunamonti 51, 06122 Perugia, Italy. Tel: +39-075-5783453; Fax: +39-075-5729946; E-mail: oncolab{at}hotmail.com

Background: We explored the correlation between serum human epidermal growth factor receptor-2 (HER2) extracellular domain (ECD) and tissue HER2 status, their relationship with clinicopathological parameters and their impact on disease-free survival (DFS) and overall survival in early breast cancer patients.

Patients and methods: This prospective trial included patients with stage I–III breast cancer. Serum HER2 ECD levels were measured by two enzyme-linked immunosorbent assays before surgical treatment. Tissue HER2 status was analyzed by immunohistochemistry (IHC) in all tumors; FISH assay was utilized in HER2 2+ tumors by IHC.

Results: From May 2000 to July 2005, 256 consecutive stage I–III breast cancer patients were included in this study. High serum HER2 ECD levels (≥15 ng/ml) were reported in 23 patients (9.0%) and HER2-positive status in tumor tissue was observed in 42 patients (16.4%) with a concordance of 87.1%. High HER2 ECD levels were significantly associated with high histological grade (P = 0.003), stage III (P = 0.008), lymph node involvment (P = 0.035) and negativity of both estrogen (P = 0.016) and progesterone (P = 0.007) receptors. At multivariate analysis, high serum HER2 ECD levels were a significant independent prognostic factor of worse DFS (P = 0.009).

Conclusions: A statistically significant association was observed between high serum HER2 ECD levels and worse DFS in early breast cancer patients.

Key words: early breast cancer, HER2 ECD, prognosis

{dagger} These authors contributed equally to this work.

Received for publication October 2, 2007. Revision received December 1, 2007. Accepted for publication December 3, 2007.


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