Efficacy of fulvestrant in the treatment of postmenopausal women with endocrine-resistant advanced breast cancer in routine clinical practice
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This study aimed to describe the efficacy of fulvestrant 500 mg in postmenopausal women with estrogen receptor (ER)-positive advanced/metastatic breast cancer who had disease progression after receiving anti-estrogen therapy in clinical practice, getting real-world data.
Materials and methods
Multicenter, retrospective, observational study conducted in Spain. Postmenopausal women with locally advanced/metastatic ER-positive breast cancer who received treatment with fulvestrant 500 mg after progression with a previous anti-estrogen therapy were eligible. The primary endpoint was progression-free survival (PFS); secondary endpoints were overall survival (OS), clinical benefit rate (CBR), duration of clinical benefit (DoCB), and safety profile.
A total of 263 women were evaluated (median age, 65.8 years). At a median follow-up of 21.5 months, median PFS and OS were 10.6 and 43.2 months, respectively. PFS according to 1st, 2nd, 3rd, and ≥ 4th lines were 11.5, 10.6, 9.9, and 8.5 months, respectively (p = 0.0245). PFS in patients with visceral involvement was 10 months vs 10.6 months in patients without visceral involvement (p = 0.6604), 9.6 months in patients with high Ki67 vs 10 months in patients with low Ki67 (p = 0.7224), and 10.2 months in HER2+ patients vs 10.3 months in HER2− patients (p = 0.6809). The CBR was 56.5% and the DoCB was 18.4 months. The most frequently adverse events were injection site pain (10.3%) and musculoskeletal disorders (7.6%).
Fulvestrant 500 mg administered in clinical practice was shown to be effective (PFS, 10.6 months; CBR, 56.5%) and well tolerated, in accordance with previous trials.
KeywordsMetastatic breast cancer Postmenopausal women Hormone receptor-positive advanced breast cancer Fulvestrant
We thank the participating patients and their families, all nurses and other members of the staff for their valuable contribution. We also appreciate Ana López-Ballesteros and Antonio Torres-Ruiz (Dynamic Science) for their medical-writing support and editorial assistance.
Compliance with ethical standards
Conflict of interest
JMBC participated as an advisor for AstraZeneca; IB, JSB and MRB (study coordinators) received honoraria from AstraZeneca. None of the other authors has declared any conflict of interest.
The study was conducted in accordance with the 1964 Declaration of Helsinki and its later amendments. The study was approved by the Independent Research Ethics Committee at Hospital Universitario San Cecilio (Granada, Spain).
Informed consent was obtained from all individual participants before being included in the study.
The study described within the paper was sponsored by Astra Zeneca Spain S.A., Madrid, Spain.
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