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
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
randomisationand the earliest evidence of progression or death from any cause2,4 Objectiveresponse 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 + disease2
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)
|During adjuvant therapy
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
35% not responsive¶ to last hormonal therapy before
The majority were under 65 years of age, with a median of 61 years2
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
Adapted from Di Leo A, et al. J Clin Oncol. 2010;28(30):4594-4600.2
CONFIRM final OS analysis at 75% maturity*6
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.
Adapted from Di Leo A, et al. J Natl Cancer Inst. 2014;106(1):djt337
*No adjustments for multiplicity were made.
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
|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