Results from the Phase III FALCON study show superior median progression-free survival for Faslodex (fulvestrant) in breast cancer- AstraZeneca

New data from the Phase III FALCON trial demonstrates superior median progression-free survival (PFS) for Faslodex (fulvestrant 500mg), from AstraZeneca, compared to anastrozole 1mg in the 1st line treatment of postmenopausal women with locally-advanced or metastatic breast cancer, who have not had prior hormonal treatment for hormone receptor positive (HR+) breast cancer. The primary endpoint was PFS and the FALCON trial enrolled 462 patients.

The results show that the median PFS was 2.8 months longer with fulvestrant than anastrozole (Hazard ratio 0.797; 95% confidence interval: 0.637-0.999; p=0.0486). The median PFS was 16.6 months in the fulvestrant arm, compared with 13.8 months in the anastrozole arm.1 Aromatase inhibitors, such as anastrozole, are the current standard of care in 1st line treatment for postmenopausal women with hormone-receptor positive (HR+) advanced breast cancer. The safety and tolerability profile was in line with current experience with fulvestrant and anastrozole. The most commonly reported adverse events in the fulvestrant and anastrozole arms were arthralgia (16.7% vs 10.3%), hot flashes (11.4% vs 10.3%), and nausea (10.5% vs 10.3%), respectively. Data were announced at the 2016 European Society for Medical Oncology (ESMO) Congress.