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

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A Correction to this article was published on 03 October 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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  • 03 October 2018

    A sentence under ‘Results’ heading in the Abstract section was published incorrectly. The correct sentence should read as follows:

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Acknowledgements

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.

Author information

Authors and Affiliations

  1. Hospital Universitario Clínico San Cecilio, Complejo Hospitalario Universitario, C/Dr. Oloriz, 16, 18012, Granada, Spain

    I. Blancas

  2. Hospital Clinic de Barcelona, illarroel, 170, 08036, Barcelona, Spain

    M. Fontanillas

  3. Hospital Universitario Virgen de las Nieves, Av. de las Fuerzas Armadas, S/N, 18014, Granada, Spain

    V. Conde

  4. Hospital Universitario Miguel Servet, Paseo Isabel la Católica, 1-3, 50009, Zaragoza, Spain

    J. Lao

  5. Hospital Provincial de Castellón, Av. del Dr. Clarà, 19, 12002, Castelló de la Plana, Spain

    E. Martínez

  6. Hospital Universitario Clínico San Carlos, C/del Profesor Martín Lagos, s/n, 28040, Madrid, Spain

    M. J. Sotelo

  7. Hospital de Jaén, Avda. del Ejército Español, nº 10, 23007, Jaén, Spain

    A. Jaen

  8. Hospital Juan Ramón Jiménez, Ronda Exterior Norte s/n, 21005, Huelva, Spain

    J. L. Bayo

  9. Hospital Universitario Carlos Haya, Av. de Carlos Haya, s/n, 29010, Málaga, Spain

    F. Carabantes

  10. Complejo Universitario Hospital de Navarra, Calle Irunlarrea, 3, 31008, Pamplona, Spain

    J. J. Illarramendi

  11. Hospital de Jerez, Ronda de Circunvalación s/n, 11407, Cádiz, Spain

    M. M. Gordon

  12. Hospital Universitario de Canarias, Carretera de Ofra, s/n, 38320, Santa Cruz de Tenerife, Spain

    J. Cruz

  13. Complejo Universitario Asistencial de León, C/Altos de Nava, s/n, León, Spain

    A. García-Palomo

  14. Hospital Universitario, 12 de Octubre, Avenida de Córdoba, s/n, 28041, Madrid, Spain

    C. Mendiola

  15. Hospital Costa del Sol, Autovia A-7, Km 187, 29603, Marbella, Spain

    E. Pérez-Ruiz

  16. Hospital Nuestra Señora De Valme, Av. de Bellavista, s/n, 41014, Seville, Spain

    J. S. Bofill

  17. Hospital Universitario Puerta del Mar, Av. Ana de Viya, 21, 11009, Cádiz, Spain

    J. M. Baena-Cañada

  18. Hospital Ramón y Cajal, Ctra. de Colmenar Viejo, km. 9,100, 28034, Madrid, Spain

    N. M. Jáñez

  19. Clínica Benidorm, Av. Alfonso Puchades, 03501, Benidorm, Spain

    G. Esquerdo

  20. Hospital Universitario Virgen del Rocío, Av. Manuel Siurot, s/n, 41013, Seville, Spain

    M. Ruiz-Borrego

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  1. I. Blancas
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  2. M. Fontanillas
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Corresponding author

Correspondence to I. Blancas.

Ethics declarations

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.

Funding

The study described within the paper was sponsored by Astra Zeneca Spain S.A., Madrid, Spain.

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Blancas, I., Fontanillas, M., Conde, V. et al. Efficacy of fulvestrant in the treatment of postmenopausal women with endocrine-resistant advanced breast cancer in routine clinical practice. Clin Transl Oncol 20, 862–869 (2018). https://doi.org/10.1007/s12094-017-1797-9

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  • DOI: https://doi.org/10.1007/s12094-017-1797-9

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