[Fulvestrant use in clinical practice in France: a pharmacoepidemiologic study]

The objective of the study was to assess the prescription patterns of fulvestrant in clinical practice in France through a retrospective observational study. Primary endpoint was treatment duration. Data from patients who completed fulvestrant therapy between January and May 2007 were collected between May and June 2007 in 50 centers selected among a representative study sample of 110 centers. Two hundred seventeen patients were included. For 98-99% of patients, baseline characteristics were consistent with the approved indication in terms of postmenopausal status, estrogen-receptor positive tumors and treatment for advanced disease. Overall, 94% of patients had received previous endocrine therapy: tamoxifen in 60% and aromatase-inhibitor (AI) in 90%, including 35% exposed to AI as the unique prior endocrine therapy. Median duration of fulvestrant therapy was six months, and fulvestrant was the ultimate hormone therapy in 89% of evaluable patients. Fulvestrant is prescribed in the real practice in post-menopausal patients with ER-positive tumors, after prior hormone therapy and for advanced disease in the vast majority of patients, according to drug labeling. Due to the growing population receiving AI after or instead of tamoxifen, most patients given fulvestrant in 2007 in France were previously exposed to AI.