Fulvestrant: A Review in Advanced Breast Cancer Not Previously Treated with Endocrine Therapy
Fulvestrant (Faslodex®), a selective estrogen receptor (ER) degrader, is now indicated for the treatment of ER+ or hormone-receptor positive (HR+)/HER2− advanced breast cancer in postmenopausal women previously untreated with endocrine therapy. In the phase 3 FALCON trial conducted in this setting, intramuscular fulvestrant 500 mg/month (plus an additional dose at 2 weeks) was significantly more effective in prolonging progression-free survival (PFS) than oral anastrozole 1 mg/day (particularly in patients with non-visceral disease), with this benefit seemingly driven by fulvestrant recipients responding significantly longer to treatment. Other efficacy measures, including objective response rate, did not significantly or markedly differ between the two regimens and median overall survival was not yet calculable. Fulvestrant was generally well tolerated in this trial, displaying an overall tolerability profile consistent with its known tolerability in other breast cancer settings. Thus, monotherapy with intramuscular fulvestrant is a generally well tolerated and more effective treatment option than standard-of-care anastrozole for ER+ or HR+/HER2− advanced breast cancer in postmenopausal women not previously treated with endocrine therapy.
During the peer review process, the manufacturer of fulvestrant was also offered the opportunity to review this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.
Compliance with Ethical Standards
The preparation of this review was not supported by any external funding.
Conflict of interest
Emma Deeks is a salaried employee of Adis/Springer, is responsible for the article content and declares no relevant conflicts of interest.
Additional information about this Adis Drug Review can be found at http://www.medengine.com/Redeem/C7CCF06013B1BD22.
- 3.American Cancer Society. Breast cancer facts and figures 2015–2016. 2015. https://www.cancer.org. Accessed 17 Nov 2017.
- 5.National Comprehensive Cancer Network. NCCN clinical practice guidelines in oncology (NCCN Guidelines®). Breast cancer version 3.2017. 2017. http://www.nccn.org. Accessed 11 Dec 2017.
- 6.AstraZeneca UK Limited. Faslodex 250 mg solution for injection: EU summary of product characteristics. 2017. http://www.ema.europa.eu/ema. Accessed 11 Dec 2017.
- 7.AstraZeneca. Faslodex® (fulvestrant) injection, for intramuscular use: US prescribing information. 2017. https://www.accessdata.fda.gov. Accessed 11 Dec 2017.
- 10.Robertson JF, Nicholson RI, Bundred NJ, et al. Comparison of the short-term biological effects of 7alpha-[9-(4,4,5,5,5-pentafluoropentylsulfinyl)-nonyl]estra-1,3,5, (10)-triene-3,17beta-diol (Faslodex) versus tamoxifen in postmenopausal women with primary breast cancer. Cancer Res. 2001;61(18):6739–46.PubMedGoogle Scholar
- 28.Robertson JFR, Cheung K-L, Noguchi S, et al. Health-related quality of life from a phase 3 randomized trial of fulvestrant 500 mg vs anastrozole for hormone receptor-positive advanced breast cancer (FALCON) [abstract no. 1048]. J Clin Oncol. 2017;35(15 Suppl.).Google Scholar
- 29.Roberston JFR, Di Leo A, Fazal M, et al. Fulvestrant for hormone receptor-positive advanced breast cancer in patients with visceral vs non-visceral metastases: findings from FALCON, FIRST, and CONFIRM [abstract]. In: San Antonio Breast Cancer Symposium, 2017.Google Scholar
- 30.Nunes AP, Green E, Dalvi T, et al. A real-world evidence study to define the prevalence of endocrine therapy-naive hormone receptor-positive locally advanced or metastatic breast cancer in the US [abstract no. P5-08-20]. Cancer Res. 2017;77(4 Suppl.).Google Scholar
- 31.Bastiaannet E, Charman J, Borge Johannesen T, et al. A real-world evidence study of patients with hormone receptor positive locally advanced or metastatic breast cancer at primary diagnosis [abstract no. 377]. Eur J Cancer. 2016;57(Suppl. 2):S107–8.Google Scholar
- 33.Ding H, Fang L, Xin W, et al. Cost-effectiveness analysis of fulvestrant versus anastrozole as first-line treatment for hormone receptor-positive advanced breast cancer. Eur J Cancer Care (Engl). 2017. https://doi.org/10.1111/ecc.12733.
- 34.Robert NJ, Denduluri N. Patient case lessons: endocrine management of advanced breast cancer. Clin Breast Cancer. 2017. https://doi.org/10.1016/j.clbc.2017.05.014.
- 35.Telford C, Takyar S, Joshi P, et al. A network meta-analysis of fulvestrant vs alternative first-line endocrine therapies for endocrine therapy-naive postmenopausal hormone receptor-positive advanced or metastatic breast cancer [abstract no. e12545]. J Clin Oncol. 2017;35(15 Suppl).Google Scholar