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The FALCON trial found no significant difference in overall survival between fulvestrant and anastrozole for advanced breast cancer. However, fulvestrant showed a trend toward improved survival in patients with nonvisceral disease.

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Area of Science:

  • Oncology
  • Clinical Trials
  • Endocrinology

Background:

  • The FALCON trial previously showed improved progression-free survival (PFS) with fulvestrant versus anastrozole.
  • Hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer requires effective endocrine therapies.

Purpose of the Study:

  • To report the final overall survival (OS) analysis from the randomized phase III FALCON trial.
  • To compare the long-term efficacy of fulvestrant and anastrozole in postmenopausal women with endocrine therapy-naïve advanced breast cancer.

Main Methods:

  • A randomized phase III trial comparing fulvestrant and anastrozole.
  • Final overall survival (OS) analysis conducted after primary PFS analysis.
  • Descriptive analyses with nominal P values were used.

Main Results:

  • No significant difference in OS was observed between fulvestrant and anastrozole (median OS: 44.8 vs 42.7 months; HR, 0.97; P = .7579).
  • A trend suggested a 15% reduction in the relative risk of death with fulvestrant in patients with nonvisceral disease (median OS: 65.2 vs 47.8 months).

Conclusions:

  • Fulvestrant did not demonstrate a significant overall survival benefit compared to anastrozole in the overall study population.
  • Findings suggest a potential long-term clinical benefit of fulvestrant in the subset of patients with nonvisceral disease, consistent with existing evidence.