(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.

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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.