Anastrozole versus tamoxifen as first-line therapy in postmenopausal patients with hormone-dependent advanced breast cancer: a prospective, randomized, phase III study

Am J Clin Oncol. 2003 Jun;26(3):317-22. doi: 10.1097/01.COC.0000047126.10522.F9.

Abstract

A prospective phase III trial comparing anastrozole with tamoxifen as first-line therapy in postmenopausal, hormone-dependent, advanced breast cancer (ABC). Patients were randomized to anastrozole 1 mg daily (n = 121) or tamoxifen 40 mg daily (n = 117). Efficacy and tolerability were evaluated after 3 months' therapy, and survival was evaluated at median time of follow-up. At a median follow-up of 13.3 months, clinical benefit (CB) was achieved in 83% and 56% of anastrozole and tamoxifen patients, respectively (p < 0.001); median time to disease progression (TTP) in patients achieving CB was 18.0 months and 7.0 months, respectively, (hazard ratio [HR] = 0.13, 95% CI = 0.08-0.20, p < 0.01). At data cutoff, 89% of tamoxifen patients had died, compared with 60% of anastrozole patients; median time to death was 17.4 months and 16.0 months, respectively (HR = 0.64, 95% CI = 0.47-0.86, p = 0.003). Therapy was well tolerated in both groups. Anastrozole showed significant advantages over tamoxifen for CB, median TTP in patients gaining CB, and survival. These data further support routine use of anastrozole as first-line treatment for postmenopausal hormone-dependent ABC.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase III
  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Anastrozole
  • Antineoplastic Agents, Hormonal / therapeutic use*
  • Aromatase Inhibitors
  • Bone Neoplasms / drug therapy
  • Bone Neoplasms / secondary
  • Breast Neoplasms / drug therapy*
  • Breast Neoplasms / pathology
  • Enzyme Inhibitors / therapeutic use*
  • Female
  • Humans
  • Lung Neoplasms / drug therapy
  • Lung Neoplasms / secondary
  • Middle Aged
  • Neoplasms, Hormone-Dependent / drug therapy*
  • Neoplasms, Hormone-Dependent / pathology
  • Nitriles / therapeutic use*
  • Postmenopause
  • Prospective Studies
  • Remission Induction
  • Survival Analysis
  • Tamoxifen / therapeutic use*
  • Triazoles / therapeutic use*

Substances

  • Antineoplastic Agents, Hormonal
  • Aromatase Inhibitors
  • Enzyme Inhibitors
  • Nitriles
  • Triazoles
  • Tamoxifen
  • Anastrozole