Nichols Hazel B, Stürmer Til, Lee Valerie S, Anderson Chelsea, Lee Jean S, Roh Janise M, Visvanathan Kala, Muss Hyman, Kushi Lawrence H
Hazel B. Nichols, Til Stürmer, and Chelsea Anderson, University of North Carolina Gillings School of Global Public Health; Hyman Muss, University of North Carolina School of Medicine, Chapel Hill, NC; Valerie S. Lee, Jean S. Lee, Janise M. Roh, and Lawrence H. Kushi, Kaiser Permanente Northern California, Oakland, CA; and Kala Visvanathan, Johns Hopkins Bloomberg School of Public Health and Johns Hopkins School of Medicine, Baltimore, MD.
JCO Clin Cancer Inform. 2017 Nov;1:1-12. doi: 10.1200/CCI.16.00059.
National guidelines encourage counseling high-risk women about pharmacologic breast cancer risk reduction. We evaluated the use of integrated health care data to identify and characterize breast cancer chemoprevention use. Chemoprevention included US Food and Drug Administration-approved use of tamoxifen and raloxifene and off-label use of aromatase inhibitors (AIs).
Using electronic medical and pharmacy records (EMRs) in the Kaiser Permanente Northern California health care system, we sampled cancer-free women age 35 to 69 years who used tamoxifen, raloxifene, exemestane, anastrozole, or letrozole from 2005 to 2013. Risk-benefit profiles were calculated for tamoxifen and raloxifene using published indices. The proportion of days covered was calculated from pharmacy records to assess adherence.
Among 90 chemoprevention users (confirmed with EMR review from a sample of 371 women), 74% used tamoxifen, 11% used raloxifene, and 13% used an AI. For tamoxifen and raloxifene users, the risk-benefit index indicated 23% of women had insufficient evidence that benefits would outweigh risks. For all agents, adherence decreased from an average proportion of days covered of 75% at 1 year to 67% at 5 years. Automated EMR searches identified breast cancer chemoprevention users with 60% positive predictive value overall and 75% for tamoxifen after post hoc modifications.
Our study contributes to an emerging picture of breast cancer chemoprevention use in real-world settings, where evidence of net benefit is not uniform and nonadherence is common. Among breast cancer chemoprevention agents, our automated selection best performed for tamoxifen use. We also identified off-label use of AIs for chemoprevention, suggesting that expansion of risk-benefit indices to include AIs is warranted.
国家指南鼓励为高危女性提供关于药物降低乳腺癌风险的咨询。我们评估了利用综合医疗保健数据来识别和描述乳腺癌化学预防药物的使用情况。化学预防包括美国食品药品监督管理局批准的他莫昔芬和雷洛昔芬的使用，以及芳香化酶抑制剂（AIs）的非标签使用。
利用北加利福尼亚凯撒医疗保健系统中的电子病历和药房记录，我们对2005年至2013年期间使用他莫昔芬、雷洛昔芬、依西美坦、阿那曲唑或来曲唑的35至69岁无癌女性进行了抽样。使用已发表的指标计算他莫昔芬和雷洛昔芬的风险效益概况。从药房记录中计算覆盖天数的比例以评估依从性。
在90名化学预防药物使用者中（通过对371名女性样本的电子病历审查确认），74%使用他莫昔芬，11%使用雷洛昔芬，13%使用芳香化酶抑制剂。对于他莫昔芬和雷洛昔芬使用者，风险效益指数表明23%的女性没有足够证据证明益处会超过风险。对于所有药物，依从性从1年时平均覆盖天数比例的75%下降到5年时的67%。电子病历自动搜索识别出乳腺癌化学预防药物使用者，总体阳性预测值为60%，对他莫昔芬进行事后修改后为75%。
我们的研究有助于呈现现实环境中乳腺癌化学预防药物使用的新情况，即净效益的证据并不一致且不依从情况普遍。在乳腺癌化学预防药物中，我们的自动筛选在他莫昔芬使用方面表现最佳。我们还发现了芳香化酶抑制剂用于化学预防的非标签使用情况，这表明有必要将风险效益指数扩展到包括芳香化酶抑制剂。
