Fulvestrant in metastatic breast cancer: Safety, efficacy, and role as mainteinance therapy for heavily pretreated patients

1133 Background: Chemotherapy is the most aggressive medical option for metastatic breast cancer patients. However, treatment is frequently associated to severe hematological toxicity that compels a chemotherapy-rest. Hormone-sensitive metastatic breast cancer patients could benefit in these cases from a monthly intramuscular injection of fulvestrant, a pure estrogen receptors antagonist. Methods: Since November 2005 to December 2007 we tested objective responses, clinical benefit, and safety of once-a-month fulvestrant 250 mg as therapy after disease progression or for maintenance of heavily pretreated hormone-sensitive breast cancer patients. Results: Among 121 enrolled patients, 101 of them were evaluable: 98 females and 3 males, ECOG performance status (PS) 0–3, median age 59 years (range 27–87), HER-2/neu overexpression in 16%, bone plus visceral disease in 73% of cases. All the patients were pretreated with at least 2 endocrine therapy lines and a median of 3 chemotherapy regimens (range 1–8). Fulve...