(ChemotherapyAdvisor) – In women with advanced breast cancer who had minimal previous exposure to adjuvant aromatase inhibitors (AI), the combination of fulvestrant and anastrozole “added no value” to anastrozole alone, results of a study in the Journal of Clinical Oncology published online February 27 concluded.
Two-thirds of the patients had previously been exposed to adjuvant antiestrogens; however, only eight had received an AI, the study authors noted.
The open-label Phase 3 Fulvestrant and Anastrozole Combination Therapy (FACT) trial randomly assigned postmenopausal women with estrogen-receptor-positive and/or progesterone-receptor-positive disease at first relapse after primary treatment of localized disease to a loading-dose schedule of fulvestrant 250mg plus anastrozole 1mg/day (n=258) or anastrozole 1mg/day alone (n=256). Also included in the study were premenopausal women receiving a gonadotropin-releasing hormone agonist; all were considered to be candidates for primary endocrine therapy.
Median time to progression, the primary outcome measure, was 10.8 months in the fulvestrant plus anastrozole arm vs. 10.2 months in the anastrozole alone arm (HR=0.99; P=0.91). Median overall survival was 37.8 in the combination therapy arm and 38.2 months in the control arm (HR=1.0; P=1.00).
Hot flashes occurred in 63 patients (24.6%) in the fulvestrant plus anastrozole arm compared with 35 patients (13.8%) in the anastrozole alone arm. There were 11 deaths (4.3%) in the fulvestrant plus anastrozole arm and 5 (2.0%) in the anastrozole alone arm.