Fulvestrant in postmenopausal women with metastatic breast cancer progressing on prior endocrine therapy -results from a compassionate use progra

Publisher Website
Google Scholar
Abstract
730 Background: Fulvestrant (Faslodex) is an estrogen receptor (ER) antagonist with no agonist effects. Here we report results from a compassionate use/named patient program in which postmenopausal women with metastatic breast cancer progressing on at least two prior endocrine therapies were treated with fulvestrant 250 mg. Methods: Fulvestrant 250 mg was given as a single 5 mL intramuscular injection, once-monthly until disease progression (PD). Tumor response was assessed monthly using UICC criteria. Time to progression (TTP) and duration of response (DOR; responding patients only) were defined from start of treatment until PD. Results: Between August 2001 and October 2003, 44 patients (median age 63 years [range 39–91 years]) were treated and followed-up for a median of 28 weeks (range 12–104 weeks). All had received prior endocrine treatment for advanced disease and 50% had received adjuvant endocrine treatment. Thirty patients (68%) had received prior chemotherapy. Most patients (75%) received fulvestrant as 3rd- or 4th-line endocrine treatment for advanced disease. Three patients (7%) had a partial response (PR); at time of analysis PRs were of 40, 76 and 104 weeks duration. Twenty patients (45%) had stable disease (SD) ≥24 weeks giving a clinical benefit (CB) rate (PR + SD ≥24 weeks) of 52%. Median TTP was 22 weeks. Fulvestrant 250 mg was well tolerated with no WHO grade III/IV toxicities observed. Conclusions: Fulvestrant 250 mg has demonstrable efficacy and a good tolerability profile in postmenopausal patients with metastatic breast cancer. More than 50% of patients gained CB from fulvestrant treatment despite most having received 2–3 prior endocrine therapies. No significant financial relationships to disclose.

This publication has 0 references indexed in Scilit: