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.

COMBINATION WITH PALBOCICLIB

PALOMA-3 STUDY DESIGN

FASLODEX 500 mg was studied in combination with palbociclib 125 mg vs FASLODEX plus placebo (the control arm).* PALOMA-3, a phase 3, international, randomised, double-blind, parallel-group, multicentre study in women (N=521) with HR-positive, HER2-negative ABC or mBC, regardless of their menopausal status, whose disease progressed on or after prior endocrine therapy.3,4

Patients were randomised 2:1 to FASLODEX plus palbociclib or the control arm, and stratified by documented sensitivity to prior hormonal therapy, menopausal status at study entry (pre-/peri- vs postmenopausal), and presence of visceral metastases.3,4

The primary endpoint was investigator-assessed PFS, evaluated according to RECIST v.1.1.3,4

Pre- or postmenopausal women with ER-resistant, HR+, HER2- ABC were randomised to Faslodex + palbociclib (n=347) or Faslodex + placebo (n=174)3
Pre- or postmenopausal women with ER-resistant, HR+, HER2- ABC were randomised to Faslodex + palbociclib (n=347) or Faslodex + placebo (n=174)3

Adapted from Cristofanilli, M et al. Lancet Oncol. 2016;17(4):425-439.3

 

 

Prior therapy in PALOMA-3
  • All patients received prior systemic therapy3,4      
  • 75% of patients received a previous chemotherapy regimen, 34% of which was in the metastatic setting       
  • Patients were permitted to have 1 prior line of chemotherapy for advanced disease and/or multiple lines of prior endocrine therapy3

ABC=advanced breast cancer; AI=aromatase inhibitor; ER=oestrogen receptor; HER2=human epidermal growth factor receptor 2; HR=hormone receptor; mBC=metastatic breast cancer; PFS=progression-free survival; RECIST=Response Evaluation Criteria in Solid Tumors.

*Patients in both arms received FASLODEX 500 mg by intramuscular injection on Days 1, 15, and 29 of the first month, and every 28 (± 3) days thereafter, and either oral palbociclib 125 mg or placebo for 21 consecutive days followed by 7 days off treatment.3

† Women who were either premenopausal  or perimenopausal  were therapeutically induced to become postmenopausal and represented 20.7% of the study population.3,4

Disease relapse or progression had to occur during or within 1 month after treatment in the advanced setting, or during or within 12 months of completion of adjuvant therapy.

§All pre/perimenopausal women had to have commenced treatment with a LHRHa at least 4 weeks before randomisation. During the treatment period, all pre/perimenopausal women received LHRHa at the time of fulvestrant administration.

Efficacy of FASLODEX in combination with palbociclib in PALOMA-3

Primary endpoint PFS

Treatment with FASLODEX 500 mg in combination with Palbociclib was associated with a 54% reduction in the risk of disease progression compared to treatment with FASLODEX 500 mg alone (HR 0.46; 95% CI 0.36 - 0.59; p<0.00013,4

Median PFS 9.5 months with Faslodex + palbociclib vs 4.6 months with Faslodex + placebo (HR=0.46; 95% CI 0·36–0·59); p<0.0001.3
Median PFS 9.5 months with Faslodex + palbociclib vs 4.6 months with Faslodex + placebo (HR=0.46; 95% CI 0·36–0·59); p<0.0001.3

Adapted from Cristofanilli, M et al. Lancet Oncol. 2016;17(4):425-439.3

FASLODEX in combination with palbociclib showed consistent PFS results across select subgroups3

PFS results were consistent across select subgroups3
PFS results were consistent across select subgroups3

Adapted from Cristofanilli, M et al. Lancet Oncol. 2016;17(4):425-439.3

FASLODEX SAFETY

SAFETY PROFILE OF FASLODEX IN COMBINATION WITH PALBOCICLIB

  • In PALOMA-3 14 patients (4%) in the FASLODEX plus palbociclib arm vs. 3 patients (2%) in the FASLODEX plus placebo arm, discontinued treatment because of an AE.3
  • The most frequently reported adverse reactions in PALOMA-3 were infections, neutropenia, leukopenia, anaemia, thrombocytopenia, decreased appetite, nausea, stomatitis, diarrhoea, vomiting, alopecia, rash, fatigue and pyrexia.3
  • The most common (~2%) Grade 8 adverse reactions were neutropenia, leukopenia, anaemia, infections, AST increased, thrombocytopenia, and fatigue.4

Undesirable effects4

FASLODEX combined with palbociclib: For further details, consult the FASLODEX SPC and palbociclib SPC.

Very Common Infections, neutropenia, leukopenia, anaemia, thrombocytopenia, decreased appetite, nausea, stomatitis, diarrhoea, vomiting, alopecia, rash, fatigue and pyrexia.  
Common  Dysgeusia, lacrimation increased, vision blurred, dry eye, epistaxis, dry skin, asthenia, AST increased and ALT increased. 
UnCommon Febrile neutropenia. For further details of adverse reactions, particularly neutropenia, please consult FASLODEX SPC.