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

• I. Blancas ^[12] ; M. Fontanillas ^[1] ; V. Conde ^[2] ; J. Lao ^[3] ; E. Martínez ^[13] ; M. J. Sotelo ^[4] ; A. Jaen ^[14] ; J. L. Bayo ^[5] ; F. Carabantes ^[15] ; J. J. Illarramendi ^[16] ; M. M. Gordon ^[6] ; J. Cruz ^[7] ; A. García-Palomo ^[17] ; C. Mendiola ^[18] ; E. Pérez-Ruiz ^[8] ; J. S. Bofill ^[19] ; J. M. Baena-Cañada ^[9] ; N. M. Jáñez ^[10] ; G. Esquerdo ^[20] ; M. Ruiz-Borrego ^[11]
  1. [1] Hospital Clinic Barcelona

     Hospital Clinic Barcelona

     Barcelona, España

     
  2. [2] Hospital Universitario Virgen de las Nieves

     Hospital Universitario Virgen de las Nieves

     Granada, España

     
  3. [3] Hospital Miguel Servet

     Hospital Miguel Servet

     Zaragoza, España

     
  4. [4] Hospital Clínico San Carlos de Madrid

     Hospital Clínico San Carlos de Madrid

     Madrid, España

     
  5. [5] Hospital Juan Ramón Jiménez

     Hospital Juan Ramón Jiménez

     Huelva, España

     
  6. [6] Hospital de Jerez

     Hospital de Jerez

     Jerez de la Frontera, España

     
  7. [7] Hospital Universitario de Canarias

     Hospital Universitario de Canarias

     San Cristóbal de La Laguna, España

     
  8. [8] Hospital Costa Del Sol

     Hospital Costa Del Sol

     Marbella, España

     
  9. [9] Hospital Universitario Puerta del Mar

     Hospital Universitario Puerta del Mar

     Cádiz, España

     
  10. [10] Hospital Ramón y Cajal

      Hospital Ramón y Cajal

      Madrid, España

      
  11. [11] Hospital Universitario Virgen del Rocío

      Hospital Universitario Virgen del Rocío

      Sevilla, España

      
  12. [12] Hospital Universitario Clínico San Cecilio, España
  13. [13] Hospital Provincial de Castellón, España
  14. [14] Hospital de Jaén, España
  15. [15] Hospital Universitario Carlos Haya, España
  16. [16] Complejo Universitario Hospital de Navarra, España
  17. [17] Complejo Universitario Asistencial de León, España
  18. [18] Hospital Universitario Madrid, España
  19. [19] Hospital Nuestra Señora De Valme, España
  20. [20] Clínica Benidorm, España

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• Localización: Clinical & translational oncology, ISSN 1699-048X, Vol. 20, Nº. 7 (July 2018), 2018, págs. 862-869
• Idioma: inglés
• Texto completo no disponible (Saber más ...)
• Resumen

  • 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.