University of Vermont College of Medicine, Burlington, Vermont.
Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.
Cancer Prev Res (Phila). 2021 Jul;14(7):753-762. doi: 10.1158/1940-6207.CAPR-20-0581. Epub 2021 Apr 13.
Current therapies for breast cancer prevention only prevent estrogen receptor positive (ER+) disease and toxicity limits use of these agents. Vitamin D is a potential prevention therapy for both ER+ and ER- disease and is safe with few side effects. This study evaluates the effect of 1-year of vitamin D supplementation on mammographic density (MD), a biomarker of breast cancer risk in a multicenter randomized controlled trial. Premenopausal women with ≥25% MD and no history of cancer were randomly assigned to 2,000 international units (IU) of vitamin D or placebo orally daily for 1 year. Change in percent MD was evaluated using Cumulus software after all participants completed treatment. Three hundred women enrolled between January 2011 and December 2013 with a mean age of 43 and diverse ethnicity [14% Hispanic, 12% African American (AA)]. Supplementation significantly increased vitamin D levels compared with placebo (14.5 ng/mL vs. -1.6 ng/mL; < 0.0001) with all participants on the vitamin D arm achieving vitamin D sufficiency at 12 months. Vitamin D was safe and well tolerated. After adjustment for baseline MD, the mean between-arm difference (vitamin D vs. placebo) at 1 year was -0.75 (-0.26, 1.76; = 0.56). A greater effect was seen for women with ≥50% MD and AA women, although neither reached significance. This randomized controlled trial demonstrated significant improvement in vitamin D levels with 2,000 IU for 1 year, with 100% of supplemented women achieving sufficiency. However, a null effect was seen regarding change in MD for premenopausal women (the primary outcome of the study). PREVENTION RELEVANCE: Current therapies for breast cancer prevention only prevent estrogen receptor positive (ER+) disease and are underutilized due to toxicity and side effects. Vitamin D is a potential prevention therapy for both ER+ and ER- disease and is safe with few side effects.
目前的乳腺癌预防疗法仅能预防雌激素受体阳性（ER+）疾病，而且由于毒性和副作用，这些药物的使用受到限制。维生素 D 是一种潜在的 ER+和 ER-疾病预防治疗方法，且安全性高，副作用少。本研究评估了为期 1 年的维生素 D 补充对乳腺密度（MD）的影响，MD 是乳腺癌风险的生物标志物，这是一项多中心随机对照试验。具有≥25%MD 且无癌症病史的绝经前妇女被随机分配至每日口服 2000 国际单位（IU）维生素 D 或安慰剂 1 年。所有参与者完成治疗后，使用 Cumulus 软件评估 MD 的百分比变化。2011 年 1 月至 2013 年 12 月期间，300 名年龄中位数为 43 岁且种族多样的女性（14%西班牙裔，12%非裔美国人（AA））入组。与安慰剂相比，补充剂显著增加了维生素 D 水平（14.5ng/mL 比-1.6ng/mL；<0.0001），所有接受维生素 D 治疗的参与者在 12 个月时均达到了维生素 D 充足水平。维生素 D 是安全且耐受良好的。在调整基线 MD 后，1 年时组间差异（维生素 D 与安慰剂）的平均值为-0.75（-0.26，1.76；=0.56）。在 MD≥50%的女性和 AA 女性中观察到更大的效果，但均未达到统计学意义。这项随机对照试验显示，每日补充 2000IU 维生素 D 持续 1 年可显著提高维生素 D 水平，补充的女性中有 100%达到充足水平。然而，对于绝经前女性，MD 变化方面未观察到显著效果（这是该研究的主要结局）。预防相关性：目前的乳腺癌预防疗法仅能预防雌激素受体阳性（ER+）疾病，而且由于毒性和副作用，这些药物的使用受到限制。维生素 D 是一种潜在的 ER+和 ER-疾病预防治疗方法，且安全性高，副作用少。
