PMID- 22370325
OWN - NLM
STAT- MEDLINE
DCOM- 20120730
LR  - 20220317
IS  - 1527-7755 (Electronic)
IS  - 0732-183X (Linking)
VI  - 30
IP  - 16
DP  - 2012 Jun 1
TI  - FACT: an open-label randomized phase III study of fulvestrant and anastrozole in 
      combination compared with anastrozole alone as first-line therapy for patients 
      with receptor-positive postmenopausal breast cancer.
PG  - 1919-25
LID - 10.1200/JCO.2011.38.1095 [doi]
AB  - PURPOSE: To compare the effect of therapy with anastrozole versus a combination 
      of fulvestrant and anastrozole in women in first relapse of endocrine-responsive 
      breast cancer. PATIENTS AND METHODS: Postmenopausal women, or premenopausal women 
      receiving a gonadotropin-releasing hormone agonist, with estrogen receptor- 
      and/or progesterone receptor-positive disease at first relapse after primary 
      treatment of localized disease were open-label randomly assigned to a fulvestrant 
      loading dose (LD) regimen followed by monthly injection plus 1 mg of anastrozole 
      daily or to 1 mg of anastrozole daily alone. The primary end point was time to 
      progression (TTP). RESULTS: In all, 514 women were randomly assigned to 
      fulvestrant plus anastrozole (experimental arm; n = 258) or anastrozole (standard 
      arm; n = 256). Approximately two thirds had received adjuvant antiestrogens, but 
      only eight individuals had received an aromatase inhibitor. Median TTP was 10.8 
      and 10.2 months in the experimental versus standard arm, respectively (hazard 
      ratio [HR] = 0.99; 95% CI, 0.81 to 1.20; P = .91); median overall survival was 
      37.8 and 38.2 months, respectively (HR = 1.0; 95% CI, 0.76 to 1.32; P = 1.00). 
      Incidences of prespecified adverse events (AEs) were similar. Hot flashes were 
      more common in the experimental arm: 63 patients (24.6%) versus 35 patients 
      (13.8%) in the standard arm (P = .0023). Death owing to AEs was reported in 11 
      (4.3%) and five patients (2.0%) in the experimental versus standard arm, 
      respectively. CONCLUSION: Fulvestrant (250 mg + LD regimen) in combination with 
      anastrozole offered no clinical efficacy advantage over anastrozole monotherapy 
      in this population of individuals with a relatively high proportion of previous 
      adjuvant antiestrogen exposure.
FAU - Bergh, Jonas
AU  - Bergh J
AD  - Karolinska Institutet, Stockholm, Sweden. jonas.bergh@ki.se
FAU - Jonsson, Per-Ebbe
AU  - Jonsson PE
FAU - Lidbrink, Elisabet Kerstin
AU  - Lidbrink EK
FAU - Trudeau, Maureen
AU  - Trudeau M
FAU - Eiermann, Wolfgang
AU  - Eiermann W
FAU - Brattstrom, Daniel
AU  - Brattstrom D
FAU - Lindemann, Justin P O
AU  - Lindemann JP
FAU - Wiklund, Fredrik
AU  - Wiklund F
FAU - Henriksson, Roger
AU  - Henriksson R
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20120227
PL  - United States
TA  - J Clin Oncol
JT  - Journal of clinical oncology : official journal of the American Society of 
      Clinical Oncology
JID - 8309333
RN  - 0 (Nitriles)
RN  - 0 (Receptors, Estrogen)
RN  - 0 (Triazoles)
RN  - 22X328QOC4 (Fulvestrant)
RN  - 2Z07MYW1AZ (Anastrozole)
RN  - 4TI98Z838E (Estradiol)
SB  - IM
CIN - J Clin Oncol. 2012 Jun 1;30(16):1897-900. PMID: 22547606
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Anastrozole
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse effects/*therapeutic use
MH  - Breast Neoplasms/*drug therapy
MH  - Estradiol/administration & dosage/*analogs & derivatives
MH  - Female
MH  - Fulvestrant
MH  - Humans
MH  - Middle Aged
MH  - Neoplasms, Hormone-Dependent/drug therapy
MH  - Nitriles/*administration & dosage/adverse effects
MH  - Receptors, Estrogen/metabolism
MH  - Recurrence
MH  - Triazoles/*administration & dosage/adverse effects
EDAT- 2012/03/01 06:00
MHDA- 2012/07/31 06:00
CRDT- 2012/02/29 06:00
PHST- 2012/02/29 06:00 [entrez]
PHST- 2012/03/01 06:00 [pubmed]
PHST- 2012/07/31 06:00 [medline]
AID - JCO.2011.38.1095 [pii]
AID - 10.1200/JCO.2011.38.1095 [doi]
PST - ppublish
SO  - J Clin Oncol. 2012 Jun 1;30(16):1919-25. doi: 10.1200/JCO.2011.38.1095. Epub 2012 
      Feb 27.