open access

Vol 13, No 1 (2017)
Review paper
Published online: 2017-07-21
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Fulvestrant in hormonal treatment of breast cancer

Sylwia Dębska-Szmich, Agnieszka Zięba, Piotr Potemski
DOI: 10.5603/OCP.2017.0003
·
Oncol Clin Pract 2017;13(1):14-23.

open access

Vol 13, No 1 (2017)
REVIEW ARTICLES
Published online: 2017-07-21

Abstract

Fulvestrant is a selective oestrogen receptor (ER) down-regulator (SERD), which lacks partial agonistic properties characteristic for selective oestrogen receptor modulators (SERM). The drug is indicated for the treatment of hormone receptor-positive metastatic breast cancer in postmenopausal women with disease progression following antioestrogen therapy. The initial recommendation of a 250-mg dose was based on the results of clinical trials, which revealed that fulvestrant was non-inferior to anastrozole in this indication. However, the higher the dose of fulvestrant, the more effective it is. The CONFIRM trial compared a 500-mg dose with the approved dose of fulvestrant of 250 mg per month for treatment of postmenopausal women with oestrogen receptor-positive advanced breast cancer, who progressed after prior endocrine therapy. It showed that the higher dose was associated with a statistically significant increase in progression-free survival without increased toxicity, and it became the basis of approval of a fulvestrant dose of 500 mg in 2010. The drug should be administered intramuscularly on days 0, 14 and 28 and once monthly thereafter. The phase III FALCON trial, to which postmenopausal breast cancer patients who had not received previous endocrine therapy were eligible, revealed that a 500-mg fulvestrant dose reduced the risk of progression by 20% compared with anastrozole in first-line treatment. Fulvestrant is also beneficial in third and further lines of hormonal treatment of breast cancer and remains efficacious in young patients treated with LHRH analogue. There have also been numerous trials investigating the efficacy of fulvestrant combined with molecular targeted therapy in patients with hormone-resistant metastatic breast cancers. This review summarises the mechanism of action of fulvestrant and the results of the most important clinical trials dedicated to this drug.

Abstract

Fulvestrant is a selective oestrogen receptor (ER) down-regulator (SERD), which lacks partial agonistic properties characteristic for selective oestrogen receptor modulators (SERM). The drug is indicated for the treatment of hormone receptor-positive metastatic breast cancer in postmenopausal women with disease progression following antioestrogen therapy. The initial recommendation of a 250-mg dose was based on the results of clinical trials, which revealed that fulvestrant was non-inferior to anastrozole in this indication. However, the higher the dose of fulvestrant, the more effective it is. The CONFIRM trial compared a 500-mg dose with the approved dose of fulvestrant of 250 mg per month for treatment of postmenopausal women with oestrogen receptor-positive advanced breast cancer, who progressed after prior endocrine therapy. It showed that the higher dose was associated with a statistically significant increase in progression-free survival without increased toxicity, and it became the basis of approval of a fulvestrant dose of 500 mg in 2010. The drug should be administered intramuscularly on days 0, 14 and 28 and once monthly thereafter. The phase III FALCON trial, to which postmenopausal breast cancer patients who had not received previous endocrine therapy were eligible, revealed that a 500-mg fulvestrant dose reduced the risk of progression by 20% compared with anastrozole in first-line treatment. Fulvestrant is also beneficial in third and further lines of hormonal treatment of breast cancer and remains efficacious in young patients treated with LHRH analogue. There have also been numerous trials investigating the efficacy of fulvestrant combined with molecular targeted therapy in patients with hormone-resistant metastatic breast cancers. This review summarises the mechanism of action of fulvestrant and the results of the most important clinical trials dedicated to this drug.

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Keywords

breast cancer, hormonal therapy, fulvestrant, hormone-resistance

About this article
Title

Fulvestrant in hormonal treatment of breast cancer

Journal

Oncology in Clinical Practice

Issue

Vol 13, No 1 (2017)

Article type

Review paper

Pages

14-23

Published online

2017-07-21

DOI

10.5603/OCP.2017.0003

Bibliographic record

Oncol Clin Pract 2017;13(1):14-23.

Keywords

breast cancer
hormonal therapy
fulvestrant
hormone-resistance

Authors

Sylwia Dębska-Szmich
Agnieszka Zięba
Piotr Potemski

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