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Fulvestrant: a review of its development, pre-clinical and clinical data
1Department of Medical Oncology, Christie Hospital, Withington, Manchester, UK.
Abstract:
Hormone therapy is the most important systemic treatment of hormone receptor-positive breast cancer at all stages. Selective oestrogen receptor modulators (SERMs), such as tamoxifen, the mainstay of hormone receptor positive breast cancer manipulation for many years, are limited by their agonist actions. Oestrogen-like activity of these drugs may stimulate cancer growth such as in the endometrium and is a mechanism of resistance in breast cancer. Fulvestrant, the first of a new class of drugs, an oestrogen receptor down regulator, may have advantages over tamoxifen in the treatment of oestrogen-dependent disease. The pre-clinical development and early clinical data of fulvestrant are reviewed. Fulvestrant was as effective as the aromatase inhibitor anastrazole in second-line advanced breast cancer. The phase III trial of fulvestrant versus tamoxifen, as first-line treatment for metastatic breast cancer, has completed accrual and is maturing. Fulvestrant has useful activity against breast cancer as well as a favourable side-effect profile and is likely to represent a useful addition to the fight against hormone dependent breast cancer. Its place will be better defined by ongoing clinical trials.
Insights
Fulvestrant, a new estrogen receptor downregulator, shows promise in treating hormone-dependent breast cancer. It may offer advantages over tamoxifen and has a favorable side-effect profile.
Area of Science:
- Oncology
- Endocrinology
- Pharmacology
Background:
- Hormone therapy is crucial for hormone receptor-positive breast cancer.
- Selective estrogen receptor modulators (SERMs) like tamoxifen have limitations due to estrogen-like activity.
- This activity can stimulate cancer growth and lead to resistance.
Purpose of the Study:
- To review the preclinical development and early clinical data of fulvestrant.
- To evaluate fulvestrant as a potential alternative to tamoxifen for estrogen-dependent breast cancer.
Main Methods:
- Review of preclinical data.
- Analysis of early clinical trial results comparing fulvestrant to anastrozole and tamoxifen.
Main Results:
- Fulvestrant demonstrated efficacy comparable to anastrozole in second-line advanced breast cancer.
- A Phase III trial comparing fulvestrant to tamoxifen in first-line metastatic breast cancer is maturing.
- Fulvestrant exhibits useful activity and a favorable side-effect profile.
Conclusions:
- Fulvestrant represents a potentially valuable addition to hormone-dependent breast cancer treatment.
- Ongoing clinical trials will further define its role in breast cancer therapy.