Dietary fat reduction and breast cancer outcome: Interim efficacy results from the Women's Intervention Nutrition Study
Dietary fat reduction and breast cancer outcome: Interim efficacy results from the Women's Intervention Nutrition Study
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DOI：
10.1093/jnci/djj494
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发表时间：
2006-12-20
影响因子：
10.3
通讯作者：
Elashoff, Robert M.
中科院分区：
文献类型：
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作者：
Chlebowski, Rowan T.;Blackburn, George L.;Elashoff, Robert M.
背景资料：临床前和观察性研究表明，膳食脂肪摄入量与乳腺癌之间存在关系，但这种关联仍然存在争议。我们进行了一项随机、前瞻性、多中心临床试验，以测试饮食干预对接受传统癌症管理的切除早期乳腺癌女性的影响。研究方法：在1994年2月至2001年1月期间，共2437名妇女按40：60的比例被随机分配到饮食干预组（n = 975）或对照组（n = 1462）。中期分析是在中位随访60个月后进行的，当时干预资金停止。采用t检验比较了饮食干预组和对照组在营养素摄入量和人体测量变量方面的平均差异。采用Kaplan-Meier分析、分层对数秩检验和考克斯比例风险模型检查无复发生存期。统计检验是双侧的。结果如下：干预组的膳食脂肪摄入量低于对照组（12个月时的脂肪克/天，分别为33.3 [95%置信区间{CI} = 32.2至34.5]与51.3 [95% CI = 50.0至52.7]; P
Background: Preclinical and observational studies suggest a relationship between dietary fat intake and breast cancer, but the association remains controversial. We carried out a randomized, prospective, multicenter clinical trial to test the effect of a dietary intervention designed to reduce fat intake in women with resected, early-stage breast cancer receiving conventional cancer management. Methods: A total of 2437 women were randomly assigned between February 1994 and January 2001 in a ratio of 40 : 60 to dietary intervention (n = 975) or control (n = 1462) groups. An interim analysis was performed after a median follow-up of 60 months when funding for the intervention ceased. Mean differences between dietary intervention and control groups in nutrient intakes and anthropometric variables were compared with t tests. Relapse-free survival was examined using Kaplan-Meier analysis, stratified log-rank tests, and Cox proportional hazards models. Statistical tests were two-sided. Results: Dietary fat intake was lower in the intervention than in the control group (fat grams/day at 12 months, 33.3 [95% confidence interval {CI} = 32.2 to 34.5] versus 51.3 [95% CI = 50.0 to 52.7], respectively; P