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Fulvestrant (‘Faslodex’) in heavily pretreated postmenopausal patients with advanced breast cancer: single centre clinical experience from the compassionate use programme

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Abstract

Background

Fulvestrant (Faslodex) is an oestrogen receptor (ER) antagonist with demonstrated efficacy in patients with advanced and pretreated breast cancer.

Patients and methods

We present a single-centre experience with fulvestrant administered under the compassionate use programme (CUP) to a total of 54 postmenopausal women with metastatic breast cancer progressing on multiple endocrine and cytotoxic therapies. Patients received 250 mg fulvestrant i.m. once monthly as second- (n = 8), third- (n = 30), fourth- (n = 14) and fifth-line (n = 2) hormonal treatment. The median number of previous endocrine therapies was 2 (range 1–4). Most of the patients also had multiple palliative chemotherapies with a median of 1.7 (range 0–6) prior therapies. The median duration of fulvestrant treatment was 6.3 months (range 1–39 months) and the median duration of follow-up was 19.4 months (range 1–63 months).

Results

Objective response was achieved by five patients (9.3%): one complete remission (CR) (1.9%) and four partial remissions (PR) (7.4%). Stable disease (SD) lasting ≥6 months was achieved by 16 patients (29.6%). Thus in all, fulvestrant conferred clinical benefit (CB) on 21 women (38.9%). The median time to progression (TTP) was 6.4 months. In all patients with CR and PR, tumour cells were positive for both ER and progesterone receptor (PgR), but lacked HER2/neu overexpression; one patient with PR had an unknown HER2/neu status. Overall, the drug was well tolerated. No grade 3/4 toxicities were reported.

Conclusions

Fulvestrant appears to be an efficient and well-tolerated drug even in women with advanced breast cancer progressing after multiple endocrine and/or cytotoxic treatments.

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Acknowledgements

This was work supported by the Verein für Klinische Malignom und Zytokinforschung Salzburg-IBK and the Arbeitsgemeinschaft für die wissenschaftliche Erforschung von Tumorerkrankungen. This compassionate use programme was supported by AstraZeneca Pharmaceuticals.

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Authors and Affiliations

  1. III Medical Department with Haematology, Medical Oncology, Haemostaseology, Rheumatology and Infectious Disease, Paracelsus Private Medical University Salzburg, and Laboratory of Immunological and Molecular Cancer Research, Müllner Hauptstrasse 48, 5020 , Salzburg, Austria

    Brigitte Mlineritsch, Oskar Psenak, Peter Mayer, Martin Moik, Konrad Namberger & Richard Greil

  2. Department of Pathology, Paracelsus Private Medical University Salzburg, Salzburg, Austria

    Cornelia Hauser-Kronberger

Authors
  1. Brigitte Mlineritsch
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  2. Oskar Psenak
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  3. Peter Mayer
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  4. Martin Moik
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  5. Konrad Namberger
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  6. Cornelia Hauser-Kronberger
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  7. Richard Greil
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Corresponding author

Correspondence to Richard Greil.

Additional information

B. Mlineritsch and O. Psenak contributed equally to the work.

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Mlineritsch, B., Psenak, O., Mayer, P. et al. Fulvestrant (‘Faslodex’) in heavily pretreated postmenopausal patients with advanced breast cancer: single centre clinical experience from the compassionate use programme. Breast Cancer Res Treat 106, 105–112 (2007). https://doi.org/10.1007/s10549-006-9482-7

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  • DOI: https://doi.org/10.1007/s10549-006-9482-7

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