FASLODEXTM
(fulvestrant)

FASLODEXTM is indicated as monotherapy for the treatment of oestrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women:

  • Not previously treated with endocrine therapy, or
  • With disease relapse on or after adjuvant antioestrogen therapy, or disease progression on antioestrogen therapy

Faslodex is also indicated in combination with palbociclib for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in women who have received prior endocrine therapy.

  • In pre- or perimenopausal women, the combination treatment with palbociclib should be combined with a luteinising hormone releasing hormone agonist.

Monotherapy in endocrine therapy naïve patients

Efficacy of FASLODEX monotherapy in FALCON

In FALCON, FASLODEX monotherapy demonstrated longer PFS vs. anastrozole, in endocrine-naive HR+ ABC patients

PFS in the intention-to-treat population

A patient’s first therapy in HR-positive, HER2-negative advanced breast cancer is an important choice. Postmenopausal patients who received FASLODEX as an initial monotherapy in the FALCON Trial had a 21% reduction in the risk of disease progression (HR=0.797; 95% CI 0·637–0·999; p=0·0486).1,4

 

Median PFS 16.6 months with Faslodex 500mg vs 13.8 months with anastrazole 1 mg (HR=0.797; 95% CI 0·637–0·999; p=0·0486).<sup>1,4</sup>
Median PFS 16.6 months with Faslodex 500mg vs 13.8 months with anastrazole 1 mg (HR=0.797; 95% CI 0·637–0·999; p=0·0486).<sup>1,4</sup>

Adapted from Robertson JFR, et al. Lancet. 2016;388:2997-3005.1

  • Investigator-assessed PFS, the primary endpoint of the FALCON Trial, was evaluated according to RECIST v.1.11,4
  • Objective response rate (ORR) in patients with measurable disease was a secondary endpoint. ORR was comparable between treatment arms: 46.1% vs 44.9% in patients receiving FASLODEX (n=193) vs anastrozole (n=196), respectively1,4
  • Median duration of response (another secondary endpoint) was 20.0 months vs 13.2 months in patients receiving FASLODEX vs anastrozole, respectively1,4

HR=hormone receptor

PFS results in endocrine-naïve patients with visceral metastases and patients with non-visceral metastases1

Non-visceral metastases

Median PFS 22.3 months with Faslodex 500mg vs 13.8 months with anastrazole 1 mg (HR=0.59; 95% CI 0·42–0·84).1
Median PFS 22.3 months with Faslodex 500mg vs 13.8 months with anastrazole 1 mg (HR=0.59; 95% CI 0·42–0·84).1

Adapted from Robertson JFR, et al. Lancet. 2016;388:2997-3005.1

In patients with non-visceral metastases, median PFS was 22.3 months and 13.8 months in the FASLODEX and anastrozole arms respectively

Visceral metastases

Median PFS 13.8 months with Faslodex 500mg vs 15.9 months with anastrazole 1 mg (HR=0.99; 95% CI 0·74–1.33).1
Median PFS 13.8 months with Faslodex 500mg vs 15.9 months with anastrazole 1 mg (HR=0.99; 95% CI 0·74–1.33).1

Adapted from Robertson JFR, et al. Lancet. 2016;388:2997-3005.1

In patents with visceral metastases, median PFS was 13.8 months and 15.9 months in the FASLODEX and anastrozole arms respectively

A post-hoc interaction test to assess for consistency of the treatment effects across the visceral and non-visceral subgroups gave a p value of 0·00921

In FALCON, the PFS benefit of FASLODEX monotherapy was largely consistent across all subgroups tested

PFS in FALCON subgroups1
PFS in FALCON subgroups1
  • The analysis of the subgroup populations in the FALCON Trial was preplanned.1     
  • However, the test for heterogeneity was not statistically significant across all the subgroups1