As reported in the Journal of Clinical Oncology by John F.R. Robertson, PhD, and colleagues, the final overall survival analysis of the phase III FALCON trial showed no difference between fulvestrant vs anastrozole in patients with endocrine therapy–naive, hormone receptor–positive, HER2-negative advanced breast cancer.
John F.R. Robertson, PhD
Study Details
In the multinational trial, 462 patients were randomly assigned to receive fulvestrant (n = 230) or anastrozole (n = 232). At primary analysis, the fulvestrant group had significantly improved progression-free survival vs the anastrozole group. The final overall survival analysis was triggered at ≥ 65% data maturity and occurrence of ≥ 8 years since enrollment of the final patient.
Key Findings
Median overall survival was 44.8 months (95% confidence interval [CI] = 37.8–57.6 months) in the fulvestrant group vs 42.7 months (95% CI = 36.6–50.1 months) in the anastrozole group (hazard ratio [HR] = 0.97, 95% CI = 0.77–1.21, P = .7579).
Among 208 patients (95 in the fulvestrant group, 113 in the anastrozole group) with nonvisceral disease, a numeric benefit in overall survival was observed for the fulvestrant group vs the anastrozole group. Median overall survival was 65.2 months vs 47.8 months (difference = 17.4 months; HR = 0.85, 95% CI = 0.60–1.20).
In post hoc exploratory analyses, patients in the fulvestrant group with nonvisceral vs visceral disease had greater improvements in overall survival (median = 65.2 vs 37.2 months, difference = 28.0 months; HR = 0.62, 95% CI = 0.45–0.85) vs patients in the anastrozole group (median = 47.8 vs 40.7 months, difference = 7.1 months; HR = 0.78, 95% CI = 0.57–1.07).
The investigators concluded: “Data from FALCON are consistent with published evidence of long-term clinical benefit with fulvestrant and other endocrine therapies in the subset of patients with nonvisceral disease.”
Dr. Robertson, of the School of Medicine, University of Nottingham, Royal Derby Hospital, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: The study was supported by AstraZeneca. For full disclosures of the study authors, visit ascopubs.org.
