title: Fulvestrant versus anastrozole for the treatment of advanced breast carcinoma: a prospectively planned combined survival analysis of two multicenter trials.
abstract: BACKGROUND
  Fulvestrant is an estrogen receptor antagonist with no agonist effects. In the second-line treatment of advanced breast carcinoma, fulvestrant was shown previously to be as effective as the third-generation aromatase inhibitor, anastrozole, in terms of time to disease progression and objective response rates. The authors reported the overall survival results from these studies.
  
  
  METHODS
  A prospectively planned, combined, overall survival analysis was performed, including data from two Phase III trials that compared the efficacy and tolerability of fulvestrant (250 mg monthly; n = 428) with anastrozole (1 mg daily; n = 423) in the treatment of postmenopausal women with advanced breast carcinoma who had disease progression after receipt of previous endocrine treatment.
  
  
  RESULTS
  At an extended median follow-up of 27.0 months (range, 0-66.9 months), 319 (74.5%) patients in the fulvestrant group and 322 (76.1%) patients in the anastrozole group had died. Prolonged survival was observed with both drugs, with 10-20% of patients still alive > 5 years after randomization. The median overall survival was similar between treatments, being 27.4 months and 27.7 months in fulvestrant and anastrozole-treated patients, respectively (hazards ratio, 0.98; 95% confidence interval, 0.84-1.15; P = 0.809). Fulvestrant continued to be well tolerated, and was associated with a significantly lower incidence of joint disorders compared with anastrozole (P = 0.0234).
  
  
  CONCLUSIONS
  The current analysis showed that fulvestrant was similar to anastrozole with respect to overall survival in the second-line treatment of postmenopausal women with advanced breast carcinoma.
authors.affiliation: Department of Medical Oncology, Cancer Research UK, Christie Hospital, Manchester, United Kingdom. maria.parker@christie-tr.nwest.nhs.uk
authors.forename: Anthony
authors.initials: A
authors.lastname: Howell
authors.forename: John
authors.initials: J
authors.lastname: Pippen
authors.forename: Richard M
authors.initials: RM
authors.lastname: Elledge
authors.forename: Louis
authors.initials: L
authors.lastname: Mauriac
authors.forename: Ignace
authors.initials: I
authors.lastname: Vergote
authors.forename: Stephen E
authors.initials: SE
authors.lastname: Jones
authors.forename: Steven E
authors.initials: SE
authors.lastname: Come
authors.forename: C Kent
authors.initials: CK
authors.lastname: Osborne
authors.forename: John F R
authors.initials: JF
authors.lastname: Robertson
mesh_terms: D000077384:Anastrozole; D018931:Antineoplastic Agents, Hormonal / Q000627:therapeutic use*; D047072:Aromatase Inhibitors / Q000627:therapeutic use; D001943:Breast Neoplasms / Q000188:drug therapy*; D018572:Disease-Free Survival; D004311:Double-Blind Method; D004958:Estradiol / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D004965:Estrogen Antagonists / Q000627:therapeutic use; D005260:Female; D000077267:Fulvestrant; D006801:Humans; D009570:Nitriles / Q000009:adverse effects / Q000627:therapeutic use*; D017698:Postmenopause; D016019:Survival Analysis; D015996:Survival Rate; D014230:Triazoles / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D018931:Antineoplastic Agents, Hormonal; D047072:Aromatase Inhibitors; D004965:Estrogen Antagonists; D009570:Nitriles; D014230:Triazoles; D000077267:Fulvestrant; D000077384:Anastrozole; D004958:Estradiol