Clinical and Translational Oncology

, Volume 20, Issue 7, pp 862–869 | Cite as

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

  • 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
Research Article



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.


Metastatic 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.

Ethical standards

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

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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Copyright information

© Federación de Sociedades Españolas de Oncología (FESEO) 2017

Authors and Affiliations

  • I. Blancas
    • 1
  • M. Fontanillas
    • 2
  • V. Conde
    • 3
  • J. Lao
    • 4
  • E. Martínez
    • 5
  • M. J. Sotelo
    • 6
  • A. Jaen
    • 7
  • J. L. Bayo
    • 8
  • F. Carabantes
    • 9
  • J. J. Illarramendi
    • 10
  • M. M. Gordon
    • 11
  • J. Cruz
    • 12
  • A. García-Palomo
    • 13
  • C. Mendiola
    • 14
  • E. Pérez-Ruiz
    • 15
  • J. S. Bofill
    • 16
  • J. M. Baena-Cañada
    • 17
  • N. M. Jáñez
    • 18
  • G. Esquerdo
    • 19
  • M. Ruiz-Borrego
    • 20
  1. 1.Hospital Universitario Clínico San Cecilio, Complejo Hospitalario UniversitarioGranadaSpain
  2. 2.Hospital Clinic de BarcelonaBarcelonaSpain
  3. 3.Hospital Universitario Virgen de las NievesGranadaSpain
  4. 4.Hospital Universitario Miguel ServetZaragozaSpain
  5. 5.Hospital Provincial de CastellónCastelló de la PlanaSpain
  6. 6.Hospital Universitario Clínico San CarlosMadridSpain
  7. 7.Hospital de JaénJaénSpain
  8. 8.Hospital Juan Ramón Jiménez, Ronda Exterior Norte s/nHuelvaSpain
  9. 9.Hospital Universitario Carlos HayaMálagaSpain
  10. 10.Complejo Universitario Hospital de NavarraPamplonaSpain
  11. 11.Hospital de JerezCádizSpain
  12. 12.Hospital Universitario de CanariasSanta Cruz de TenerifeSpain
  13. 13.Complejo Universitario Asistencial de LeónLeónSpain
  14. 14.Hospital UniversitarioMadridSpain
  15. 15.Hospital Costa del SolMarbellaSpain
  16. 16.Hospital Nuestra Señora De ValmeSevilleSpain
  17. 17.Hospital Universitario Puerta del MarCádizSpain
  18. 18.Hospital Ramón y CajalMadridSpain
  19. 19.Clínica BenidormBenidormSpain
  20. 20.Hospital Universitario Virgen del RocíoSevilleSpain

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