Author/Editor		Paridaens, R; Dirix, L; Lohrisch, C; Beex, L; Nooij, M; Cameron, D; Biganzoli, L; Čufer, T; Duchateau, L; Hamilton, A; Lobelle, JP; Piccart, M
Title		Mature results of a randomized phase II multicenter study of exemestane versus tamoxifen as first-line hormone therapy for postmenopausal women with metastatic breast cancer
Type		članek
Source		Ann Oncol
Vol. and No.		Letnik 14, št. 9
Publication year		2003
Volume		str. 1391-8
Language		eng
Abstract		Background: Women with hormone-responsive metastatic breast cancer (MBC) may respond to or have stable disease with a number of hormone therapies. We explored the efficacy and safety of the steroidal aromatase inactivator exemestane as first-line hormonal therapy in MBC in postmenopausal women. Patients and methods: Patients with measurable disease were eligible if they had received no prior hormone therapy for metastatic disease and had hormone receptor positive disease or hormone receptor unknown disease with a long disease-free interval from adjuvant therapy. They were randomized to tamoxifen 20 mg/day or exemestane 25 mg/day in this open-label study. Results: Blinded independently reviewed response rates for exemestane and tamoxifen were 41% and 17%, respectively. Fifty-seven per cent of exemestane- and 42% of tamoxifen-treated patients experienced clinical benefit, defined as complete or partial response, or disease stabilization lasting at least 6 months. There was a low incidence of severe flushing, sweating, nausea and edema in women who received exemestane. One exemestane-treated patient had a pulmonary embolism with grade 4 dyspnea. Conclusion: Exemestane is well tolerated and active in the first-line treatment of hormone-responsive MBC. An ongoing EORTC phase III trial is comparing the efficacy, measuring time-to-disease progression, of exemestane and tamoxifen.
Descriptors		BREAST NEOPLASMS NEOPLASM METASTASIS TAMOXIFEN AROMATASE POSTMENOPAUSE RANDOMIZED CONTROLLED TRIALS MULTICENTER STUDIES