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雷洛昔芬对绝经后妇女乳腺癌风险的影响：MORE随机试验结果。雷洛昔芬评估的多项结果

The effect of raloxifene on risk of breast cancer in postmenopausal women: results from the MORE randomized trial. Multiple Outcomes of Raloxifene Evaluation.

作者信息

Cummings S R, Eckert S, Krueger K A, Grady D, Powles T J, Cauley J A, Norton L, Nickelsen T, Bjarnason N H, Morrow M, Lippman M E, Black D, Glusman J E, Costa A, Jordan V C

机构信息

Department of Medicine, University of California, San Francisco, USA.

出版信息

JAMA. 1999 Jun 16;281(23):2189-97. doi: 10.1001/jama.281.23.2189.

DOI:10.1001/jama.281.23.2189

PMID:10376571

Abstract

CONTEXT

Raloxifene hydrochloride is a selective estrogen receptor modulator that has antiestrogenic effects on breast and endometrial tissue and estrogenic effects on bone, lipid metabolism, and blood clotting.

OBJECTIVE

To determine whether women taking raloxifene have a lower risk of invasive breast cancer.

DESIGN AND SETTING

The Multiple Outcomes of Raloxifene Evaluation (MORE), a multicenter, randomized, double-blind trial, in which women taking raloxifene or placebo were followed up for a median of 40 months (SD, 3 years), from 1994 through 1998, at 180 clinical centers composed of community settings and medical practices in 25 countries, mainly in the United States and Europe.

PARTICIPANTS

A total of 7705 postmenopausal women, younger than 81 (mean age, 66.5) years, with osteoporosis, defined by the presence of vertebral fractures or a femoral neck or spine T-score of at least 2.5 SDs below the mean for young healthy women. Almost all participants (96%) were white. Women who had a history of breast cancer or who were taking estrogen were excluded.

INTERVENTION

Raloxifene, 60 mg, 2 tablets daily; or raloxifene, 60 mg, 1 tablet daily and 1 placebo tablet; or 2 placebo tablets.

MAIN OUTCOME MEASURES

New cases of breast cancer, confirmed by histopathology. Transvaginal ultrasonography was used to assess the endometrial effects of raloxifene in 1781 women. Deep vein thrombosis or pulmonary embolism were determined by chart review.

RESULTS

Thirteen cases of breast cancer were confirmed among the 5129 women assigned to raloxifene vs 27 among the 2576 women assigned to placebo (relative risk [RR], 0.24; 95% confidence interval [CI], 0.13-0.44; P<.001). To prevent 1 case of breast cancer, 126 women would need to be treated. Raloxifene decreased the risk of estrogen receptor-positive breast cancer by 90% (RR, 0.10; 95% CI, 0.04-0.24), but not estrogen receptor-negative invasive breast cancer (RR, 0.88; 95% CI, 0.26-3.0). Raloxifene increased the risk of venous thromboembolic disease (RR, 3.1; 95% CI, 1.5-6.2), but did not increase the risk of endometrial cancer (RR, 0.8; 95% CI, 0.2-2.7).

CONCLUSION

Among postmenopausal women with osteoporosis, the risk of invasive breast cancer was decreased by 76% during 3 years of treatment with raloxifene.

摘要

背景

盐酸雷洛昔芬是一种选择性雌激素受体调节剂，对乳腺和子宫内膜组织具有抗雌激素作用，对骨骼、脂质代谢和血液凝固具有雌激素作用。

目的

确定服用雷洛昔芬的女性患浸润性乳腺癌的风险是否更低。

设计与地点

雷洛昔芬评估的多重结果（MORE），一项多中心、随机、双盲试验，1994年至1998年期间，在25个国家（主要在美国和欧洲）的180个由社区机构和医疗实践组成的临床中心，对服用雷洛昔芬或安慰剂的女性进行了为期40个月（标准差3年）的中位随访。

参与者

共有7705名绝经后女性，年龄小于81岁（平均年龄66.5岁），患有骨质疏松症，定义为存在椎体骨折或股骨颈或脊柱T评分比年轻健康女性的平均值低至少2.5个标准差。几乎所有参与者（96%）为白人。有乳腺癌病史或正在服用雌激素的女性被排除。

干预措施

雷洛昔芬，60毫克，每日2片；或雷洛昔芬，60毫克，每日1片加1片安慰剂；或2片安慰剂。

主要观察指标

经组织病理学确诊的乳腺癌新病例。对1781名女性使用经阴道超声评估雷洛昔芬对子宫内膜的影响。通过查阅病历确定深静脉血栓形成或肺栓塞情况。

结果

在分配至雷洛昔芬组的5129名女性中确诊了13例乳腺癌，而在分配至安慰剂组的2576名女性中确诊了27例（相对风险[RR]，0.24；95%置信区间[CI]，0.13 - 0.44；P <.001）。为预防1例乳腺癌，需要治疗126名女性。雷洛昔芬使雌激素受体阳性乳腺癌的风险降低了90%（RR，0.10；95% CI，0.04 - 0.24），但对雌激素受体阴性浸润性乳腺癌没有降低作用（RR，0.88；95% CI，0.26 - 3.0）。雷洛昔芬增加了静脉血栓栓塞性疾病的风险（RR，3.1；95% CI，1.5 - 6.2），但未增加子宫内膜癌的风险（RR，0.8；95% CI，0.2 - 2.7）。