Benefit/Risk Assessment for Breast Cancer Chemoprevention With Raloxifene or Tamoxifen for Women Age 50 Years or Older
Benefit/Risk Assessment for Breast Cancer Chemoprevention With Raloxifene or Tamoxifen for Women Age 50 Years or Older
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DOI：
10.1200/jco.2010.33.0258
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发表时间：
2011-06-10
影响因子：
45.3
通讯作者：
McCaskill-Stevens, Worta
中科院分区：
文献类型：
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作者：
Freedman, Andrew N.;Yu, Binbing;McCaskill-Stevens, Worta
目的他莫昔芬和雷洛昔芬 (STAR) 的研究表明，雷洛昔芬在降低绝经后妇女患浸润性乳腺癌 (IBC) 的风险方面与他莫昔芬一样有效，并且血栓栓塞事件、子宫内膜癌和白内障的风险较低，但患非浸润性乳腺癌的风险较高（无统计学意义）。有必要总结这些药物的风险和益处。患者和方法在没有雷洛昔芬和他莫昔芬的情况下，根据乳腺癌化学预防试验估计了 IBC 和其他健康结果的基线发病率；监测、流行病学和最终结果计划；和妇女健康倡议。雷洛昔芬和他莫昔芬的效果根据 STAR 和乳腺癌预防试验进行评估。我们对健康结果进行权重，以计算雷洛昔芬与安慰剂相比以及他莫昔芬与安慰剂相比的净益处。结果雷洛昔芬或他莫昔芬治疗的风险和益处取决于年龄、种族、乳腺癌风险和子宫切除史。在 5 年期间，子宫完整的绝经后妇女雷洛昔芬的获益/风险指数优于他莫昔芬。对于没有子宫的绝经后女性，收益/风险比相似。表格中描述了雷洛昔芬和他莫昔芬的益处和风险，这些表格可以帮助识别益处大于风险的女性群体。结论我们开发了一个益处/风险指数来量化他莫昔芬或雷洛昔芬化学预防的益处。该指数可以补充临床评估，以决定是否开始化学预防以及比较雷洛昔芬与他莫昔芬的益处和风险。 J 临床肿瘤杂志 29：2327-2333。 (C) 2011 年美国临床肿瘤学会
PurposeThe Study of Tamoxifen and Raloxifene (STAR) demonstrated that raloxifene was as effective as tamoxifen in reducing the risk of invasive breast cancer (IBC) in postmenopausal women and had lower risks of thromboembolic events, endometrial cancer, and cataracts but had a nonstatistically significant higher risk of noninvasive breast cancer. There is a need to summarize the risks and benefits of these agents.Patients and MethodsBaseline incidence rates of IBC and other health outcomes, absent raloxifene and tamoxifen, were estimated from breast cancer chemoprevention trials; the Surveillance, Epidemiology and End Results Program; and the Women's Health Initiative. Effects of raloxifene and tamoxifen were estimated from STAR and the Breast Cancer Prevention Trial. We assigned weights to health outcomes to calculate the net benefit from raloxifene compared with placebo and tamoxifen compared with placebo.ResultsRisks and benefits of treatment with raloxifene or tamoxifen depend on age, race, breast cancer risk, and history of hysterectomy. Over a 5-year period, postmenopausal women with an intact uterus had a better benefit/risk index for raloxifene than for tamoxifen. For postmenopausal women without a uterus, the benefit/risk ratio was similar. The benefits and risks of raloxifene and tamoxifen are described in tables that can help identify groups of women for whom the benefits outweigh the risks.ConclusionWe developed a benefit/risk index to quantify benefits from chemoprevention with tamoxifen or raloxifene. This index can complement clinical evaluation in deciding whether to initiate chemoprevention and in comparing the benefits and risks of raloxifene versus tamoxifen. J Clin Oncol 29: 2327-2333. (C) 2011 by American Society of Clinical Oncology