I Blancas1, M Fontanillas2, V Conde3, J Lao4, E Martínez5, M J Sotelo6, A Jaen7, J L Bayo8, F Carabantes9, J J Illarramendi10, M M Gordon11, J Cruz12, A García-Palomo13, C Mendiola14, E Pérez-Ruiz15, J S Bofill16, J M Baena-Cañada17, N M Jáñez18, G Esquerdo19, M Ruiz-Borrego20. 1. Hospital Universitario Clínico San Cecilio, Complejo Hospitalario Universitario, C/Dr. Oloriz, 16, 18012, Granada, Spain. iblancas@ugr.es. 2. Hospital Clinic de Barcelona, illarroel, 170, 08036, Barcelona, Spain. 3. Hospital Universitario Virgen de las Nieves, Av. de las Fuerzas Armadas, S/N, 18014, Granada, Spain. 4. Hospital Universitario Miguel Servet, Paseo Isabel la Católica, 1-3, 50009, Zaragoza, Spain. 5. Hospital Provincial de Castellón, Av. del Dr. Clarà, 19, 12002, Castelló de la Plana, Spain. 6. Hospital Universitario Clínico San Carlos, C/del Profesor Martín Lagos, s/n, 28040, Madrid, Spain. 7. Hospital de Jaén, Avda. del Ejército Español, nº 10, 23007, Jaén, Spain. 8. Hospital Juan Ramón Jiménez, Ronda Exterior Norte s/n, 21005, Huelva, Spain. 9. Hospital Universitario Carlos Haya, Av. de Carlos Haya, s/n, 29010, Málaga, Spain. 10. Complejo Universitario Hospital de Navarra, Calle Irunlarrea, 3, 31008, Pamplona, Spain. 11. Hospital de Jerez, Ronda de Circunvalación s/n, 11407, Cádiz, Spain. 12. Hospital Universitario de Canarias, Carretera de Ofra, s/n, 38320, Santa Cruz de Tenerife, Spain. 13. Complejo Universitario Asistencial de León, C/Altos de Nava, s/n, León, Spain. 14. Hospital Universitario, 12 de Octubre, Avenida de Córdoba, s/n, 28041, Madrid, Spain. 15. Hospital Costa del Sol, Autovia A-7, Km 187, 29603, Marbella, Spain. 16. Hospital Nuestra Señora De Valme, Av. de Bellavista, s/n, 41014, Seville, Spain. 17. Hospital Universitario Puerta del Mar, Av. Ana de Viya, 21, 11009, Cádiz, Spain. 18. Hospital Ramón y Cajal, Ctra. de Colmenar Viejo, km. 9,100, 28034, Madrid, Spain. 19. Clínica Benidorm, Av. Alfonso Puchades, 03501, Benidorm, Spain. 20. Hospital Universitario Virgen del Rocío, Av. Manuel Siurot, s/n, 41013, Seville, Spain.
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.
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.
Entities:
Keywords:
Fulvestrant; Hormone receptor-positive advanced breast cancer; Metastatic breast cancer; Postmenopausal women
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