戈舍瑞林联合他莫昔芬对早期激素受体阳性乳腺癌绝经前和围绝经期妇女雌二醇水平、乳腺密度和子宫内膜厚度的影响:一项随机对照临床试验。

Combined effects of goserelin and tamoxifen on estradiol level, breast density, and endometrial thickness in premenopausal and perimenopausal women with early-stage hormone receptor-positive breast cancer: a randomised controlled clinical trial.

机构信息

Department of Breast Surgery, Zhejiang Cancer Hospital, Hangzhou, China.

出版信息

Br J Cancer. 2013 Aug 6;109(3):582-8. doi: 10.1038/bjc.2013.324. Epub 2013 Jul 16.

Abstract

BACKGROUND

This study is to investigate the effects of geserelin+tamoxifen (TAM) on estradiol level, breast density (BD), endometrial thickness (ET), and blood lipids in premenopausal and perimenopausal women with hormone receptor-positive early-stage breast cancer.

METHODS

This study recruited 110 premenopausal and perimenopausal patients with hormone receptor-positive early-stage breast cancer between 22 June 2008 and 31 December 2009 and randomly assigned them to receive either goserelin plus TAM or TAM alone for 1.5 years. Blood levels of sex hormones and lipids and ET were determined at 0, 3, 6, 12, and 18 months. Contralateral BD was also measured at 0, 12, and 18 months.

RESULTS

Five participants dropped out of the goserelin plus TAM group, and two participants dropped out of the TAM-alone group before initiation of endocrine therapy. The rest of patients received scheduled treatment and 3 years of median follow-up. No serious adverse effects were observed, and only two local recurrences have been observed in these patients. Estradiol level and BD were lower in the goserelin plus TAM group than in the TAM-alone group (P<0.05). The endometrium in the goserelin plus TAM group was significantly thinner than that in the TAM-alone group (P<0.05), and women in the TAM-alone group exhibited endometrial thickening over the course of the study. Furthermore, no significant differences in blood lipid levels were reported between the two groups.

CONCLUSION

The data from the current study demonstrated that the addition of goserelin to TAM results in downregulation of estradiol level, followed by significant reduction in BD and ET in premenopausal and perimenopausal women with hormone receptor-positive breast cancer, which may eventually lead to better outcome in these patients.

摘要

背景

本研究旨在探讨戈舍瑞林联合他莫昔芬(TAM)对激素受体阳性早期乳腺癌绝经前和围绝经期妇女雌二醇水平、乳腺密度(BD)、子宫内膜厚度(ET)和血脂的影响。

方法

本研究于 2008 年 6 月 22 日至 2009 年 12 月 31 日招募了 110 例激素受体阳性早期乳腺癌绝经前和围绝经期患者,并将其随机分为戈舍瑞林联合 TAM 组或 TAM 单药组,接受 1.5 年的治疗。分别在 0、3、6、12 和 18 个月时测定性激素和血脂水平及 ET,在 0、12 和 18 个月时测定对侧 BD。

结果

戈舍瑞林联合 TAM 组有 5 例患者脱落,TAM 单药组有 2 例患者在开始内分泌治疗前脱落。其余患者均接受了计划治疗和中位随访 3 年。未观察到严重不良事件,仅观察到这些患者中有 2 例局部复发。戈舍瑞林联合 TAM 组雌二醇水平和 BD 低于 TAM 单药组(P<0.05)。戈舍瑞林联合 TAM 组子宫内膜明显薄于 TAM 单药组(P<0.05),TAM 单药组患者在研究过程中出现子宫内膜增厚。此外,两组患者的血脂水平无显著差异。

结论

本研究数据表明,戈舍瑞林联合 TAM 可降低雌二醇水平,随后显著降低激素受体阳性乳腺癌绝经前和围绝经期妇女的 BD 和 ET,这可能最终使这些患者获得更好的结局。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/09ab/3738136/d05e42eb4714/bjc2013324f1.jpg

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