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

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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.

Original languageEnglish
Pages (from-to)97-103
Number of pages7
JournalBreast Cancer Research and Treatment
Volume106
Issue number1
DOIs
Publication statusPublished - Nov 2007

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Compassionate Use Trials
Breast Neoplasms
Therapeutics
fulvestrant
Drug Therapy
Intramuscular Injections
Progesterone Receptors
Treatment Failure

Keywords

  • Breast cancer
  • Endocrine treatment
  • Fulvestrant
  • Postmenopausal

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

@article{2242e2df0b084a55a83f29d598fecb73,
title = "Fulvestrant in heavily pre-treated patients with advanced breast cancer: Results from a single compassionate use programme centre",
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",
author = "Chiara Catania and Gilda Ascione and Laura Adamoli and {De Pas}, Tommaso and Marta Medici and Lucia Franceschelli and Elena Verri and Elena Magni and Giuseppina Sanna and Rosalba Torrisi and Aron Goldhirsch and Franco Nol{\`e}",
year = "2007",
month = "11",
doi = "10.1007/s10549-006-9481-8",
language = "English",
volume = "106",
pages = "97--103",
journal = "Breast Cancer Research and Treatment",
issn = "0167-6806",
publisher = "Springer New York LLC",
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TY - JOUR

T1 - Fulvestrant in heavily pre-treated patients with advanced breast cancer

T2 - Results from a single compassionate use programme centre

AU - Catania, Chiara

AU - Ascione, Gilda

AU - Adamoli, Laura

AU - De Pas, Tommaso

AU - Medici, Marta

AU - Franceschelli, Lucia

AU - Verri, Elena

AU - Magni, Elena

AU - Sanna, Giuseppina

AU - Torrisi, Rosalba

AU - Goldhirsch, Aron

AU - Nolè, Franco

PY - 2007/11

Y1 - 2007/11

N2 - 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.

AB - 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.

KW - Breast cancer

KW - Endocrine treatment

KW - Fulvestrant

KW - Postmenopausal

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