Fulvestrant, Formerly ICI 182,780, Is as Effective as Anastrozole in Postmenopausal Women With Advanced Breast Cancer Progressing After Prior Endocrine Treatment

Autor:	Alan Webster, Ignace Vergote, Ulrich R. Kleeberg, J Quaresma Albano, L. Mauriac, John F.R. Robertson, Charles A. Morris, A. Aschermannova, B Erikstein, Anthony Howell
Rok vydání:	2002
Předmět:	Gynecology Oncology Cancer Research medicine.medical_specialty Fulvestrant business.industry Hazard ratio Anastrozole medicine.disease Antiestrogen Breast cancer Tolerability Internal medicine Multicenter trial medicine business Survival rate medicine.drug
Zdroj:	Journal of Clinical Oncology. 20:3396-3403
ISSN:	1527-7755 0732-183X
Popis:	PURPOSE: To compare the efficacy and tolerability of fulvestrant (formerly ICI 182,780) and anastrozole in postmenopausal women with advanced breast cancer progressing after prior endocrine treatment.PATIENTS AND METHODS: Patients (n = 451) with advanced breast cancer were randomized to receive fulvestrant 250 mg as a once-monthly (one × 5 mL) intramuscular injection or an oral dose of anastrozole 1 mg in this open, parallel-group, multicenter trial. The primary end point was time to progression (TTP). Secondary end points included objective response (OR) rates, defined as complete response (CR) or partial response (PR), duration of response (DOR), and tolerability.RESULTS: Patients were followed for a median period of 14.4 months. In terms of TTP, fulvestrant was as effective as anastrozole (hazard ratio, 0.98; confidence interval [CI], 0.80 to 1.21; P = .84). Median TTP was 5.5 months for fulvestrant and 5.1 months for anastrozole. OR rates showed a numerical advantage for fulvestrant (20.7%) over anastrozole (15.7%) (odds ratio, 1.38; CI, 0.84 to 2.29; P = .20). Clinical benefit rates (CR + PR + stable disease ≥ 24 weeks) were 44.6% for fulvestrant and 45.0% for anastrozole. Median DOR was 15.0 months for fulvestrant and 14.5 months for anastrozole. Both treatments were well tolerated, with 3.2% and 1.3% of fulvestrant- and anastrozole-treated patients, respectively, withdrawn from treatment because of an adverse event.CONCLUSION: Fulvestrant was as effective as anastrozole. These data confirm that fulvestrant is an additional, effective, and well-tolerated treatment for advanced breast cancer in postmenopausal women whose disease progressed on prior endocrine therapy.
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_________::c38e097efc4041fbc96ca26ffa3a43b6 https://doi.org/10.1200/jco.2002.10.057 Zobrazit plný text záznamu