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

Research output: Contribution to journalArticlepeer-review


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.

Original languageEnglish
Pages (from-to)97-103
Number of pages7
JournalBreast Cancer Research and Treatment
Issue number1
Publication statusPublished - Nov 2007


  • Breast cancer
  • Endocrine treatment
  • Fulvestrant
  • Postmenopausal

ASJC Scopus subject areas

  • Cancer Research
  • Oncology


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