Tamoxifen for prevention of breast cancer: Report of the National Surgical Adjuvant Breast and Bowel Project P-1 study

Tamoxifen for prevention of breast cancer: Report of the National Surgical Adjuvant Breast and Bowel Project P-1 study
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DOI:
10.1093/jnci/90.18.1371
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发表时间:
1998-09-16
期刊:
JOURNAL OF THE NATIONAL CANCER INSTITUTE
影响因子:
--
通讯作者:
Wolmark, N
Wolmark, N
中科院分区:
其他
文献类型:
--
作者:
Fisher, B;Costantino, JP;Wolmark, N

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背景资料:他莫昔芬辅助治疗后对侧乳腺癌发病率降低的发现导致了这种药物可能在乳腺癌预防中发挥作用的概念。为了验证这一假设,国家外科辅助乳腺和肠道项目于1992年启动了乳腺癌预防试验(P-I)。研究方法:妇女(N = 13388)乳腺癌风险增加,因为他们1)60岁或以上,2)35-59岁,5年乳腺癌预测风险至少为1.66%,或3)有小叶原位癌病史的患者被随机分配接受安慰剂(n = 6707)或20 mg/d他莫昔芬(n = 6681)治疗5年。Call算法基于使用风险因素组合的多变量逻辑回归模型,用于估计随时间推移乳腺癌发生的概率(风险)。结果:他莫昔芬使浸润性乳腺癌的风险降低了49%(双侧P
Background: The finding of a decrease in contralateral breast cancer incidence following tamoxifen administration for adjuvant therapy led to the concept that the drug might play a role in breast cancer prevention. To test this hypothesis, the National Surgical Adjuvant Breast and Bowel Project initiated the Breast Cancer Prevention Trial (P-l) in 1992. Methods: Women (N = 13388) at increased risk for breast cancer because they 1) were 60 years of age or older, 2) were 35-59 years of age with a 5-year predicted risk for breast cancer of at least 1.66%, or 3) had a history of lobular carcinoma in situ were randomly assigned to receive placebo (n = 6707) or 20 mg/day tamoxifen (n = 6681) for 5 years. Call's algorithm, based on a multivariate logistic regression model using combinations of risk factors, was used to estimate the probability (risk) of occurrence of breast cancer over time. Results: Tamoxifen reduced the risk of invasive breast cancer by 49% (two-sided P