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依西美坦与他莫昔芬对他莫昔芬依西美坦辅助多中心(TEAM)试验中骨骼健康的影响:一项为期12个月的德国前瞻性随机子研究结果

Effects of exemestane and tamoxifen on bone health within the Tamoxifen Exemestane Adjuvant Multicentre (TEAM) trial: results of a German, 12-month, prospective, randomised substudy.

作者信息

Hadji P, Ziller M, Kieback D G, Dornoff W, Tessen H W, Menschik T, Kuck J, Melchert F, Hasenburg A

机构信息

Department of Gynecology, University Hospital of Giessen and Marburg, Marburg, Germany.

出版信息

Ann Oncol. 2009 Jul;20(7):1203-9. doi: 10.1093/annonc/mdn762. Epub 2009 Feb 13.

DOI:10.1093/annonc/mdn762
PMID:19218306
Abstract

BACKGROUND

Adjuvant treatment of hormone receptor-positive breast cancer in postmenopausal women with aromatase inhibitors may be associated with increased bone loss.

PATIENTS AND METHODS

Two hundred patients were randomised to receive exemestane or tamoxifen as adjuvant treatment of hormone receptor-positive breast cancer. Bone mineral density (BMD) was assessed by dual-energy X-ray absorptiometry at baseline and after 6 and 12 months treatment.

RESULTS

One hundred and sixty-one patients were assessable. Tamoxifen treatment resulted in a 0.5% increase from baseline in BMD at the spine, which was maintained at 12 months. Exemestane-treated patients experienced a 2.6% decrease from baseline in BMD at the spine at 6 months and a further 0.2% decrease at 12 months. There were significant differences in the changes in BMD between tamoxifen and exemestane at 6 and 12 months (P = 0.0026 and P = 0.0008, respectively). The mean changes in BMD from baseline at the total hip were also significantly different between exemestane and tamoxifen at 6 and 12 months (P = 0.0009 and P = 0.04, respectively). There was no difference between tamoxifen and exemestane in mean changes in BMD from baseline at the femoral neck.

CONCLUSIONS

Exemestane treatment resulted in an increase in bone loss at 6 months; bone loss stabilised after 6- to 12-month treatment.

摘要

背景

绝经后激素受体阳性乳腺癌患者使用芳香化酶抑制剂进行辅助治疗可能会导致骨质流失增加。

患者与方法

200例患者被随机分为接受依西美坦或他莫昔芬作为激素受体阳性乳腺癌的辅助治疗。在基线时以及治疗6个月和12个月后,通过双能X线吸收法评估骨密度(BMD)。

结果

161例患者可进行评估。他莫昔芬治疗使脊柱骨密度较基线增加了0.5%,在12个月时保持这一水平。接受依西美坦治疗的患者在6个月时脊柱骨密度较基线下降了2.6%,在12个月时进一步下降了0.2%。他莫昔芬和依西美坦在6个月和12个月时骨密度变化存在显著差异(分别为P = 0.0026和P = 0.0008)。依西美坦和他莫昔芬在6个月和12个月时全髋骨密度较基线的平均变化也存在显著差异(分别为P = 0.0009和P = 0.04)。他莫昔芬和依西美坦在股骨颈骨密度较基线的平均变化上没有差异。

结论

依西美坦治疗在6个月时导致骨质流失增加;在6至12个月治疗后骨质流失稳定。

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