Double-blind, randomised, multicentre endocrine trial comparing two letrozole doses, in postmenopausal breast cancer patients

被引:61
作者
Bajetta, E
Zilembo, N
Dowsett, M
Guillevin, L
Di Leo, A
Celio, L
Martinetti, A
Marchianò, A
Pozzi, P
Stani, S
Bichisao, E
机构
[1] Ist Nazl Studio & Cura Tumori, Div Med Oncol B, I-20133 Milan, Italy
[2] Royal Marsden Hosp, London SW3 6JJ, England
[3] Novartis Farma, Dept Med, Origgio, Italy
[4] Hop Avicenne, F-93009 Bobigny, France
关键词
oestrogens; Synacthen test; aromatase inhibitors; letrozole; breast cancer;
D O I
10.1016/S0959-8049(98)00392-X
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Letrozole is an orally competitive aromatase inhibitor. This double-blind, randomised, multicentre trial was carried out to evaluate the endocrine effects of two doses of letrozole, 0.5 mg versus 2.5 mg orally daily, in postmenopausal advanced breast cancer patients progressing after tamoxifen. The pharmacokinetics of letrozole was also assessed. 46 patients entered the trial, 22 on letrozole 0.5 mg and 24 on 2.5 mg. A significant suppression of oestrone and oestradiol levels was achieved by both letrozole doses. Neither letrozole dose induced any changes in cortisol and aldosterone production at rest or after Synacthen stimulation. Androstenedione, testosterone, 17 alpha-OH progesterone, triiodothyronine (T3) thyroxine, (T4) and thyroid-stimulating hormone (TSH) plasma levels did not show any significant changes. Sex hormone binding globulin (SHBG), follicle-stimulating hormone (FSH) and luteinising hormone (LH) levels increased significantly over time. Plasma letrozole concentrations increased until reaching steady-state values after 1 month at the dose of 0.5 mg and after 2 months at 2.5 mg. In conclusion, both letrozole doses suppressed oestrogen levels without affecting adrenal activity. (C) 1999 Elsevier Science Ltd. All rights reserved.
引用
收藏
页码:208 / 213
页数:6
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