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Published in: Clinical and Translational Oncology 7/2018

01-07-2018 | Research Article

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

Authors: I. Blancas, M. Fontanillas, V. Conde, J. Lao, E. Martínez, M. J. Sotelo, A. Jaen, J. L. Bayo, F. Carabantes, J. J. Illarramendi, M. M. Gordon, J. Cruz, A. García-Palomo, C. Mendiola, E. Pérez-Ruiz, J. S. Bofill, J. M. Baena-Cañada, N. M. Jáñez, G. Esquerdo, M. Ruiz-Borrego

Published in: Clinical and Translational Oncology | Issue 7/2018

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Abstract

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.
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Metadata
Title
Efficacy of fulvestrant in the treatment of postmenopausal women with endocrine-resistant advanced breast cancer in routine clinical practice
Authors
I. Blancas
M. Fontanillas
V. Conde
J. Lao
E. Martínez
M. J. Sotelo
A. Jaen
J. L. Bayo
F. Carabantes
J. J. Illarramendi
M. M. Gordon
J. Cruz
A. García-Palomo
C. Mendiola
E. Pérez-Ruiz
J. S. Bofill
J. M. Baena-Cañada
N. M. Jáñez
G. Esquerdo
M. Ruiz-Borrego
Publication date
01-07-2018
Publisher
Springer International Publishing
Published in
Clinical and Translational Oncology / Issue 7/2018
Print ISSN: 1699-048X
Electronic ISSN: 1699-3055
DOI
https://doi.org/10.1007/s12094-017-1797-9

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