DeMets D L, Newcomb P A, Carey P
University of Wisconsin Clinical Cancer Center, Madison 53706.
Prev Med. 1991 Jan;20(1):101-8. doi: 10.1016/0091-7435(91)90010-2.
A design to evaluate the efficacy of tamoxifen as a chemopreventive agent for breast cancer in healthy, high-risk women is proposed. Factors to be considered include basic incidence rates in the general population, definition of high risk, screening efforts, sample size, and compliance to protocol. Assuming a breast cancer incidence of 3/1,000/year in women 50-59 years old with a first degree relative with breast cancer, we estimate that approximately 16,000 subjects would need to be randomized into a tamoxifen-placebo controlled trial to detect a 50% reduction in incidence. This assumes a 5% (two-sided) significance level and 90% power. Such a trial would need to be multicentered and might cost $64 million over a 5-year period.
一项旨在评估他莫昔芬作为健康高危女性乳腺癌化学预防剂疗效的设计方案被提出。需要考虑的因素包括一般人群的基本发病率、高危的定义、筛查工作、样本量以及对方案的依从性。假设50 - 59岁有一位患乳腺癌的一级亲属的女性乳腺癌发病率为每年3/1000，我们估计大约需要16000名受试者被随机分配到他莫昔芬 - 安慰剂对照试验中，以检测发病率降低50%的情况。这假设双侧显著性水平为5%，检验效能为90%。这样一项试验需要多中心进行，并且在5年期间可能花费6400万美元。
