Abstract

536 Background: Fulvestrant (Faslodex) is an estrogen receptor (ER) antagonist with no agonist activity that reaches steady-state levels after 3–5 monthly intramuscular (IM) injections. Fulvestrant for 14–21 days prior to surgery for primary breast cancer (BC) caused a dose-dependant reduction in ER (Cancer Res 2001;61:6739–46). Here, we examine the long-term changes in ER levels in patients receiving fulvestrant as first-line endocrine therapy for locally advanced/metastatic BC. Methods: 30 patients with lesions suitable for biopsy were recruited. Fulvestrant was given as a monthly 250 mg IM injection. Biopsies were taken pre-treatment, after 4 weeks and 6 months of treatment, and at disease progression (PD). Changes in ER levels were analyzed using SPSS analysis. Tumors were assessed every 3 months using UICC criteria. Results: 23 patients had evaluable disease at 6 months: 5 had PD and 18 had clinical benefit (CB; complete response, n=1; partial response, n=5; stable disease ≥24 weeks, n=12). Overall, ...

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