Breast Cancer Research and Treatment

, Volume 106, Issue 1, pp 97–103 | Cite as

Fulvestrant in heavily pre-treated patients with advanced breast cancer: results from a single compassionate use programme centre

  • Chiara Catania
  • Gilda Ascione
  • Laura Adamoli
  • Tommaso De Pas
  • Marta Medici
  • Lucia Franceschelli
  • Elena Verri
  • Elena Magni
  • Giuseppina Sanna
  • Rosalba Torrisi
  • Aron Goldhirsch
  • Franco Nolè
Clinical Trial

Abstract

Purpose

Fulvestrant (‘Faslodex’) is an oestrogen receptor (ER) antagonist with no agonist effects. The drug was administered to heavily pre-treated patients with advanced breast cancer (ABC). Patients received Fulvestrant after disease progression (PD) on a previous endocrine treatment or as maintenance treatment after chemotherapy.

Material and methods

Fifty-seven postmenopausal women with ER and/or progesterone receptor-positive ABC resistant to previous endocrine treatments prospectively received fulvestrant 250 mg via intramuscular injection q 28.

Results

Twenty-seven patients received fulvestrant after PD and 30 received it as maintenance therapy after chemotherapy. All patients received fulvestrant as second-up to eight-line endocrine treatment for ABC. One patient (2%) had a partial response (PR) and 24 patients (42%) had stable disease ≥12 weeks (SD), including 11 patients who had SD ≥24 weeks. Thirty-two patients (56%) had de novo PD. Clinical benefit (CB; PR + SD ≥24 weeks) occurred in 12 patients (21%). Patients treated as maintenance and treated upon PD had 0 and 4% PR, 43 and 41% SD (including 20 and 19% SD ≥24 weeks), 57 and 55% PD, respectively. Overall, median time to progression (TTP) was 3 months. No differences in CB rate (20% vs. 23%), TTP (3 months vs. 3 months) and time to treatment failure (3 months vs. 3 months) were observed between patients receiving fulvestrant as maintenance therapy and those treated at PD on prior endocrine treatment. No grade 2–4 NCI-CTC toxicity was recorded.

Conclusions

Fulvestrant treatment was associated with prolonged CB and was well tolerated in this group of heavily pre-treated patients with ABC. The outcomes appeared to be similar for patients treated upon PD and those receiving fulvestrant as maintenance therapy.

Keywords

Breast cancer Endocrine treatment Fulvestrant Postmenopausal 

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Copyright information

© Springer Science+Business Media, LLC 2007

Authors and Affiliations

  • Chiara Catania
    • 1
  • Gilda Ascione
    • 1
  • Laura Adamoli
    • 1
  • Tommaso De Pas
    • 2
  • Marta Medici
    • 1
  • Lucia Franceschelli
    • 1
  • Elena Verri
    • 1
  • Elena Magni
    • 1
  • Giuseppina Sanna
    • 1
  • Rosalba Torrisi
    • 3
  • Aron Goldhirsch
    • 4
  • Franco Nolè
    • 1
  1. 1.Unit for Medical Care, Division of Medical OncologyEuropean Institute of OncologyMilanItaly
  2. 2.New Drugs Development DivisionEuropean Institute of OncologyMilanItaly
  3. 3.Research Unit of Medical SenologyEuropean Institute of OncologyMilanItaly
  4. 4.Department of MedicineEuropean Institute of OncologyMilanItaly

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