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750毫克氟维司群对雌激素受体阳性原发性乳腺癌绝经前女性的影响。

Effects of fulvestrant 750mg in premenopausal women with oestrogen-receptor-positive primary breast cancer.

作者信息

Young O E, Renshaw L, Macaskill E J, White S, Faratian D, Thomas J St J, Dixon J M

机构信息

Edinburgh Breast Unit, Western General Hospital, Edinburgh, UK.

出版信息

Eur J Cancer. 2008 Feb;44(3):391-9. doi: 10.1016/j.ejca.2007.11.007. Epub 2007 Dec 20.

Abstract

Fulvestrant (Faslodex) is a pure anti-oestrogen that reduces markers of hormone sensitivity and proliferation in postmenopausal women with oestrogen-receptor (ER)-positive breast cancer. This randomised trial compared the effects on the tumours of a single dose of 750mg fulvestrant to those of daily tamoxifen (20mg) taken 14-16 days prior to surgery in 60 premenopausal women with ER-positive primary breast cancer. There were statistically significant falls in the expression of ER and Ki67 levels compared to the baseline with both drugs. Both drugs caused a decrease in PgR expression from baseline but this was only statistically significant with fulvestrant. No statistically significant differences were seen between the two treatment groups. Fulvestrant caused an increase in circulating levels of oestradiol, irrespective of the stage of the menstrual cycle at which patients commenced treatment. No major changes were seen in LH, FSH and progesterone levels with either drug. The most common adverse events with fulvestrant were headaches, hot flushes, nausea and disturbance of menses. Contrary to previous studies with fulvestrant 250mg, these findings suggest that at a dose of 750mg fulvestrant is effective at reducing the effects of oestrogen on ER-positive breast cancer in premenopausal women.

摘要

氟维司群(芙仕得)是一种纯抗雌激素药物,可降低绝经后雌激素受体(ER)阳性乳腺癌女性的激素敏感性和增殖标志物水平。这项随机试验比较了60例ER阳性原发性乳腺癌绝经前女性中,单剂量750mg氟维司群与术前14 - 16天每日服用他莫昔芬(20mg)对肿瘤的影响。与基线相比,两种药物均使ER和Ki67水平的表达有统计学意义的下降。两种药物均使PgR表达从基线水平降低,但仅氟维司群有统计学意义。两个治疗组之间未观察到统计学显著差异。无论患者开始治疗时处于月经周期的哪个阶段,氟维司群都会导致雌二醇循环水平升高。两种药物对促黄体生成素(LH)、促卵泡生成素(FSH)和孕酮水平均未产生重大变化。氟维司群最常见的不良事件是头痛、潮热、恶心和月经紊乱。与之前使用250mg氟维司群的研究相反,这些发现表明,750mg剂量的氟维司群可有效降低雌激素对绝经前女性ER阳性乳腺癌的影响。

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