Efficacy of fulvestrant in the treatment of postmenopausal women with endocrine-resistant advanced breast cancer in routine clinical practice

Introduction 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 m...

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Published in:Clinical & translational oncology 2018-07, Vol.20 (7), p.862-869
Main Authors: Blancas, I., Fontanillas, M., Conde, V., Lao, J., Martínez, E., Sotelo, M. J., Jaen, A., Bayo, J. L., Carabantes, F., Illarramendi, J. J., Gordon, M. M., Cruz, J., García-Palomo, A., Mendiola, C., Pérez-Ruiz, E., Bofill, J. S., Baena-Cañada, J. M., Jáñez, N. M., Esquerdo, G., Ruiz-Borrego, M.
Format: Article
Language:English
Subjects:
Medicine
Medicine & Public Health
Oncology
Research Article
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Summary:Introduction 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. Results 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%). Conclusions 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.
ISSN:1699-048X
1699-3055
DOI:10.1007/s12094-017-1797-9