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.

FASLODEX MONOTHERAPY AFTER PRIOR ENDOCRINE THERAPY

CONFIRM

The CONFIRM (COmparisoN of FASLODEX In Recurrent or Metastatic Breast Cancer) Trial was a randomised, double-blind, controlled phase 3 study comparing FASLODEX 500mg vs FASLODEX 250 mg in 736 postmenopausal women with advanced breast cancer (ABC) who had disease recurrence on or after adjuvant endocrine therapy or progression following endocrine therapy for advanced disease.2,4

  • Progression-free survival (PFS) was the primary endpoint and was defined as the time between randomisation and the earliest evidence of progression or death from any cause2,4  
  • Objective response rate was a secondary endpoint and was defined as the number (%) of patients with complete response or partial response2,4

CONFIRM STUDY PATIENT POPULATION

Patients had HER2 - locally advanced or metastatic ER+ and/or PgR + disease

The median number of disease sites was 2, with levels of metastatic disease from bone-only to visceral involvement2     

  • 64% of patients had visceral involvement2

mBC=metastatic breast cancer.

Time of relapse/progression
FASLODEX 500 mg (n=362)
  FASLODEX 250 mg (n=374)
 
  N
%
N %
During adjuvant therapy
175
48.3
169
45.2
Early relapse
16
4.4
27
7.2
Late relapse
36
9.9
52
13.9
De novo
130
35.9
125
33.4
Other
5
1.4
1
0.3

Early relapse = 0-12 months after completion of adjuvant endocrine therapy
Late relapse = >12 months after completion of adjuvant endocrine therapy and after progression on first-line endocrine therapy for advanced disease
De novo = Patients presenting with de novo advanced disease and experiencing progression on first-line endocrine therapy

The majority of patients were responsive to their last hormonal therapy before randomisation2
65% responsive|| to last hormonal therapy before randomisation
35% not responsive to last hormonal therapy before randomisation or response unknown
The majority were under 65 years of age, with a median of 61 years2

||Patients were categorised as "responsive" if they had recurrence after 2 or more years on their last previous adjuvant endocrine therapy, and/or if they experienced complete response, partial response, or stable disease for greater than 24 weeks on first-line endocrine therapy for ABC.2
Patients were categorised as not responsive if they had recurrence within the first 2 years on their last previous adjuvant endocrine therapy, and if they experienced stable disease for less than 24 weeks or progressive disease on first-line endocrine therapy for ABC.2

CONFIRM STUDY EFFICACY

CONFIRM STUDY PRIMARY ENDPOINT: PFS

FASLODEX 500 mg demonstrated efficacy as monotherapy in postmenopausal women with hormone receptor (HR)-positive ABC with disease progression following endocrine therapy2,4

Median PFS 6.5 months with Faslodex 500mg vs 5.5 months with Faslodex 250 mg (HR=0.80; 95% CI 0·68–0·94).2
Median PFS 6.5 months with Faslodex 500mg vs 5.5 months with Faslodex 250 mg (HR=0.80; 95% CI 0·68–0·94).2

Adapted from Di Leo A, et al. J Clin Oncol. 2010;28(30):4594-4600.2

CONFIRM final OS analysis at 75% maturity*6

Median OS 26.4 months with Faslodex 500mg vs 22.3 months with Faslodex 250 mg (HR=0.801; 95% CI 0·69–0·96).2
Median OS 26.4 months with Faslodex 500mg vs 22.3 months with Faslodex 250 mg (HR=0.801; 95% CI 0·69–0·96).2

Nominal p-value with no adjustments made for multiplicity between the initial overall survival analysis at 50% maturity and the updated survival analysis at 75% maturity. Protocol was amended after PFS result. Crossover of treatment was allowed after PFS result.

Adapted from Di Leo A, et al. J Natl Cancer Inst. 2014;106(1):djt337

*No adjustments for multiplicity were made.

SAFETY

FASLODEX monotherapy has a well-established safety profile and is generally well tolerated1,2,4

FASLODEX as monotherapy: The most frequently reported adverse reactions to FASLODEX monotherapy are injection site reactions, asthenia, nausea, and increased hepatic enzymes (ALT, AST, ALP).4
For further details, consult the FASLODEX SPC

Undesirable effects4

Very Common Hypersensitivity reactions, hot flushes, nausea, asthenia, injection site reactions, elevated hepatic enzymes (ALT, AST, ALP), rash, joint and musculoskeletal pain. 
Common  Reduced platelet count, vomiting, diarrhoea, anorexia, urinary tract infections, venous thromboembolism, headache, back pain, elevated bilirubin, vaginal haemorrhage, neuropathy peripheral, sciatica
Uncommon Hepatic failure, hepatitis, elevated gamma-GT, vaginal moniliasis, leukorrhoea, injection site haemorrhage, injection site haematoma, neuralgia and anaphylactic reactions