Department of Surgery, Dankook University College of Medicine, Cheonan, Korea.
J Breast Cancer. 2012 Mar;15(1):51-6. doi: 10.4048/jbc.2012.15.1.51. Epub 2012 Mar 28.
According to the National Surgical Adjuvant Breast and Bowel Project P1 (NSABP-P1) study, tamoxifen can prevent 49% of invasive breast cancers in patients who have a 5-year risk of 1.67% or more. Because tamoxifen is associated with both adverse effects (endometrial cancer, stroke, pulmonary embolism) and protective effect (fracture prevention), it is necessary to weigh the risks and benefits of using tamoxifen for prevention in Korean women. This study weighed those risks and benefits.
Data were reviewed on the incidences of breast cancer, hip fracture, endometrial cancer and stroke in the absence of tamoxifen treatment in Korean women. We also reviewed NSABP-P1 data on the effects of tamoxifen on these outcomes. A risk-benefit index was calculated according to age and specific risk of breast cancer. Sensitivity analyses were performed with assumptions regarding the effects of tamoxifen.
Compared to U.S. women, the numbers of hip fractures and endometrial cancers were lower, but the number of strokes was much higher. The net benefit of tamoxifen was reduced with increasing age because of a high risk of stroke in older women. Older Korean women had more risk than benefit from tamoxifen chemoprevention. Only women younger than age 40 had a positive risk-benefit index with an average 5-year risk of breast cancer in Korea. Sensitivity analysis showed that this result was robust.
Women under the age 40 had more benefit than risk from tamoxifen chemoprevention. Tamoxifen chemoprevention should be limited to Korean women younger than age 40.
根据美国国家癌症研究所外科辅助乳腺和肠道项目 P1(NSABP-P1)研究,他莫昔芬可以预防 5 年侵袭性乳腺癌风险为 1.67%或更高的患者中的 49%。由于他莫昔芬既有不良反应(子宫内膜癌、中风、肺栓塞)也有保护作用(预防骨折),因此需要权衡韩国女性使用他莫昔芬预防的风险和获益。本研究对这些风险和获益进行了权衡。
我们回顾了韩国女性在不使用他莫昔芬治疗的情况下乳腺癌、髋部骨折、子宫内膜癌和中风的发生率,并回顾了 NSABP-P1 研究中他莫昔芬对这些结局的影响。根据年龄和特定乳腺癌风险计算了风险-获益指数。对假设他莫昔芬的效果进行了敏感性分析。
与美国女性相比,髋部骨折和子宫内膜癌的数量较低,但中风的数量要高得多。由于老年女性中风风险较高,他莫昔芬的净获益随着年龄的增长而降低。年龄较大的韩国女性使用他莫昔芬化学预防的风险大于获益。只有年龄小于 40 岁的女性,在韩国平均 5 年乳腺癌风险下,才有正的风险-获益指数。敏感性分析表明,该结果是稳健的。
年龄在 40 岁以下的女性使用他莫昔芬化学预防的获益大于风险。他莫昔芬化学预防应仅限于年龄小于 40 岁的韩国女性。