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Annals of Oncology Advance Access published online on October 29, 2009
Annals of Oncology, doi:10.1093/annonc/mdp447
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© The Author 2009. 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

Activity of fulvestrant in HER2-overexpressing advanced breast cancer

J. F. R. Robertson1,*, G. G. Steger2, P. Neven3, S. Barni4, F. Gieseking5, F. Nolè6, K. I. Pritchard7, F. P. O'Malley8, S. D. Simon9, B. Kaufman10 and L. Petruzelka11

1 Professorial Unit of Surgery, Division of Breast Surgery, University of Nottingham, Nottingham City Hospital, Nottingham, UK
2 Department of Internal Medicine I, Division of Oncology, Medical University of Vienna, Vienna, Austria
3 Department of Gynaecologic Oncology, University of Leuven, Leuven, Belgium
4 Division of Medical Oncology, Treviglio Hospital, Treviglio, Italy
5 Department of Obstetrics and Gynaecology, University Hospital Eppendorf, Hamburg, Germany
6 Department of Medicine, European Institute of Oncology, Milan, Italy
7 Faculty of Medicine, Division of Medical Oncology, Sunnybrook Odette Cancer Centre, University of Toronto, Toronto, Canada
8 Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, Canada
9 Department of Clinical Oncology, Albert Einstein Hospital, Sao Paulo, Brazil
10 Department of Oncology, Sheba Medical Center, Tel Hashomer, Israel
11 Department of Oncology, First Faculty of Medicine, Charles University, Prague, Czech Republic

* Correspondence to: Prof. J. F. R. Robertson, Division of Breast Surgery, University of Nottingham, Nottingham City Hospital, Hucknall Road, Nottingham NG5 1PB, UK. Tel: +44-115-823-1876; Fax: +44-115-823-1877; E-mail: john.robertson{at}nottingham.ac.uk

Background: Human epidermal growth factor receptor 2 (HER2) overexpression increases the aggressiveness of breast cancer cells resulting in poorer prognosis. Patients with HER2-positive disease are less responsive to endocrine therapies. Trastuzumab monotherapy results in objective responses in only ~15% of patients. Fulvestrant retains activity in cells overexpressing HER2 that are resistant to other endocrine treatments. This retrospective study evaluated response to fulvestrant treatment among HER2-positive patients with advanced breast cancer (ABC).

Patients and methods: Clinical experience data from 10 treatment centres were pooled. Postmenopausal patients with predominantly hormone receptor-positive and HER2-positive disease were included. Clinical benefit (CB) was defined as the proportion of patients achieving a response to treatment (partial or complete) or stable disease lasting ≥6 months.

Results: Data for 102 patients were analysed. Fulvestrant resulted in an overall CB rate of 42% (43/101) in HER2-positive patients and 40% (25/63) in patients with visceral disease. Median duration of treatment was 14.5 months (range 6–44 months). Fulvestrant showed activity up to the fourth line of endocrine therapy and up to the seventh line of overall therapy.

Conclusions: Results indicate that fulvestrant may be a suitable treatment option in extensively pre-treated patients with HER2-positive, hormone receptor-positive ABC. Further exploration of its use in this patient population is warranted.

advanced breast cancer, Faslodex, fulvestrant, HER2, human epidermal growth factor 2

Received for publication November 12, 2008. Revision received May 22, 2009. Accepted for publication July 23, 2009.


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