Chlebowski Rowan T, Col Nananda, Winer Eric P, Collyar Deborah E, Cummings Steven R, Vogel Victor G, Burstein Harold J, Eisen Andrea, Lipkus Isaac, Pfister David G
Health Services Research Department, American Society of Clinical Oncology, 1900 Duke Street, Suite 200, Alexandria, VA 22314, USA.
J Clin Oncol. 2002 Aug 1;20(15):3328-43. doi: 10.1200/JCO.2002.06.029.
To update an evidence-based technology assessment of chemoprevention strategies for breast cancer risk reduction. POTENTIAL INTERVENTIONS: Tamoxifen, raloxifene, aromatase inhibition, and fenretinide.
Outcomes of interest include breast cancer incidence, breast cancer-specific survival, overall survival, and net health benefit.
A comprehensive, formal literature review was conducted for relevant topics. Testimony was collected from invited experts and interested parties. The American Society of Clinical Oncology (ASCO) prescribed technology assessment procedure was followed.
More weight was given to published randomized trials. BENEFITS/HARMS: A woman's decision regarding breast cancer risk reduction strategies is complex and will depend on the importance and weight attributed to information regarding both cancer- and noncancer-related risks and benefits.
For women with a defined 5-year projected breast cancer risk of > or= 1.66%, tamoxifen (at 20 mg/d for 5 years) may be offered to reduce their risk. Risk/benefit models suggest that greatest clinical benefit with least side effects is derived from use of tamoxifen in younger (premenopausal) women (who are less likely to have thromboembolic sequelae and uterine cancer), women without a uterus, and women at higher breast cancer risk. Data do not as yet suggest that tamoxifen provides an overall health benefit or increases survival. In all circumstances, tamoxifen use should be discussed as part of an informed decision-making process with careful consideration of individually calculated risks and benefits. Use of tamoxifen combined with hormone replacement therapy or use of raloxifene, any aromatase inhibitor or inactivator, or fenretinide to lower the risk of developing breast cancer is not recommended outside of a clinical trial setting. This technology assessment represents an ongoing process and recommendations will be updated in a timely matter.
The conclusions were endorsed by the ASCO Health Services Research Committee and the ASCO Board of Directors.
更新关于降低乳腺癌风险的化学预防策略的循证技术评估。潜在干预措施：他莫昔芬、雷洛昔芬、芳香化酶抑制和非维生素A酸。
关注的结果包括乳腺癌发病率、乳腺癌特异性生存率、总生存率和净健康效益。
针对相关主题进行了全面、正式的文献综述。收集了受邀专家和相关方的证词。遵循了美国临床肿瘤学会（ASCO）规定的技术评估程序。
更重视已发表的随机试验。益处/危害：女性关于降低乳腺癌风险策略的决策很复杂，并将取决于赋予癌症相关和非癌症相关风险及益处信息的重要性和权重。
对于预计5年乳腺癌风险≥1.66%的女性，可提供他莫昔芬（每日20毫克，服用5年）以降低其风险。风险/效益模型表明，在年轻（绝经前）女性（血栓栓塞后遗症和子宫癌发生率较低）、无子宫女性以及乳腺癌风险较高的女性中使用他莫昔芬可获得最大临床益处且副作用最小。目前数据尚未表明他莫昔芬能带来整体健康益处或提高生存率。在所有情况下，使用他莫昔芬都应作为知情决策过程的一部分进行讨论，仔细考虑个体计算的风险和益处。在临床试验环境之外，不建议将他莫昔芬与激素替代疗法联合使用或使用雷洛昔芬、任何芳香化酶抑制剂或灭活剂、或非维生素A酸来降低患乳腺癌的风险。本技术评估是一个持续的过程，建议将及时更新。
这些结论得到了ASCO卫生服务研究委员会和ASCO董事会的认可。
