Winer Eric P, Hudis Clifford, Burstein Harold J, Chlebowski Rowan T, Ingle James N, Edge Stephen B, Mamounas Eleftherios P, Gralow Julie, Goldstein Lori J, Pritchard Kathleen I, Braun Susan, Cobleigh Melody A, Langer Amy S, Perotti Judy, Powles Trevor J, Whelan Timothy J, Browman George P
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):3317-27. doi: 10.1200/JCO.2002.06.020.
To conduct an evidence-based technology assessment to determine whether the routine use of anastrozole or any of the aromatase inhibitors in the adjuvant breast cancer setting is appropriate for broad-based conventional use in clinical practice. POTENTIAL INTERVENTIONS: Anastrozole, letrozole, and exemestane.
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 and is detailed in the text. Testimony was collected from invited experts and interested parties. The American Society of Clinical Oncology (ASCO)-prescribed technology assessment procedure was followed. BENEFITS/HARMS: The ASCO panel recognizes that a woman and her physician's decision regarding adjuvant hormonal therapy is complex and will depend on the importance and weight attributed to information regarding both cancer and non-cancer-related risks and benefits.
The panel was influenced by the compelling, extensive, and long-term data available on tamoxifen. Overall, the panel considers the results of the Arimidex (anastrozole) or Tamoxifen Alone or in Combination (ATAC) trial and the extensive supporting data to be very promising but insufficient to change the standard practice at this time (May 2002). A 5-year course of adjuvant tamoxifen remains the standard therapy for women with hormone receptor-positive breast cancer. The panel recommends that physicians discuss the available information with patients, and, in making a decision, acknowledge that treatment approaches can change over time. Individual health care providers and their patients will need to come to their own conclusions, with careful consideration of all of the available data. (Specific questions addressed by the panel are summarized in Appendix 3.)
The conclusions of the panel were endorsed by the ASCO Health Services Research Committee and the ASCO Board of Directors.
进行一项基于证据的技术评估,以确定在辅助性乳腺癌治疗中常规使用阿那曲唑或任何一种芳香化酶抑制剂是否适合在临床实践中广泛常规应用。潜在干预措施:阿那曲唑、来曲唑和依西美坦。
感兴趣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,并在文中详细阐述。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。益处/危害:ASCO专家小组认识到,女性及其医生关于辅助激素治疗的决策很复杂,将取决于赋予癌症和非癌症相关风险及益处信息的重要性和权重。
专家小组受到关于他莫昔芬的令人信服、广泛且长期的数据的影响。总体而言,专家小组认为阿那曲唑或他莫昔芬单独或联合使用(ATAC)试验的结果及大量支持数据很有前景,但目前(2002年5月)不足以改变标准治疗方法。对于激素受体阳性乳腺癌女性,5年疗程的辅助他莫昔芬治疗仍是标准疗法。专家小组建议医生与患者讨论现有信息,并且在做决定时承认治疗方法可能随时间变化。个体医疗服务提供者及其患者需要自行得出结论,同时仔细考虑所有可用数据。(专家小组解决的具体问题总结在附录3中。)
专家小组的结论得到了ASCO卫生服务研究委员会和ASCO董事会的认可。