Fulvestrant versus anastrozole for the treatment of advanced breast carcinoma: a prospectively planned combined survival analysis of two multicenter trials

Cancer. 2005 Jul 15;104(2):236-9. doi: 10.1002/cncr.21163.


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.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase III
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Anastrozole
  • Antineoplastic Agents, Hormonal / therapeutic use*
  • Aromatase Inhibitors / therapeutic use
  • Breast Neoplasms / drug therapy*
  • Disease-Free Survival
  • Double-Blind Method
  • Estradiol / adverse effects
  • Estradiol / analogs & derivatives*
  • Estradiol / therapeutic use
  • Estrogen Antagonists / therapeutic use
  • Female
  • Fulvestrant
  • Humans
  • Nitriles / adverse effects
  • Nitriles / therapeutic use*
  • Postmenopause
  • Survival Analysis
  • Survival Rate
  • Triazoles / adverse effects
  • Triazoles / therapeutic use*


  • Antineoplastic Agents, Hormonal
  • Aromatase Inhibitors
  • Estrogen Antagonists
  • Nitriles
  • Triazoles
  • Fulvestrant
  • Anastrozole
  • Estradiol