Bryant J, Fisher B, Dignam J
National Surgical Adjuvant Breast and Bowel Project (NSABP) Biostatistical Center, 1 Sterling Plaza, 230 N. Craig St., Pittsburgh, PA 15213, USA.
J Natl Cancer Inst Monogr. 2001(30):56-61. doi: 10.1093/oxfordjournals.jncimonographs.a003462.
The benefit of using adjuvant tamoxifen to treat breast cancer has been firmly established for patients with estrogen receptor (ER)-positive tumors, regardless of age, lymph node status, or menopausal status. Uncertainty remains, however, regarding the optimal duration of tamoxifen therapy. We reviewed the findings of randomized clinical trials that directly compared alternative treatment durations. Trials comparing short-term adjuvant treatment with tamoxifen (i.e., 1-3 years) with treatments having durations of about 5 years consistently have demonstrated additional benefits stemming from the longer therapy. Trials testing 5 years of treatment with longer durations have, in the aggregate, suggested no additional benefit for the patient. Nevertheless, the number of recurrences reported to date in these trials is not large, and the results of the individual trials are heterogeneous. Furthermore, as a result of tamoxifen's "carryover" effect, duration trials require considerable follow-up before definitive results can be established. Until more definitive data become available, adjuvant treatment with tamoxifen should be limited to 5 years outside the clinical trials setting. Continued accrual of ER-positive patients to ongoing tamoxifen duration trials, including the Adjuvant Tamoxifen Treatment Offer More (aTTom) and Adjuvant Tamoxifen Longer Against Shorter (ATLAS) trials, is appropriate. Alternatively, patients who remain disease free after 5 years of tamoxifen therapy should be encouraged to participate in trials testing crossover to other hormonal interventions, including selective ER modulators or aromatase inhibitors.
对于雌激素受体（ER）阳性肿瘤患者，无论年龄、淋巴结状态或绝经状态如何，使用辅助性他莫昔芬治疗乳腺癌的益处已得到明确证实。然而，关于他莫昔芬治疗的最佳疗程仍存在不确定性。我们回顾了直接比较不同疗程的随机临床试验结果。将他莫昔芬短期辅助治疗（即1 - 3年）与约5年疗程的治疗进行比较的试验一致表明，较长疗程的治疗有额外益处。总体而言，测试5年以上疗程治疗的试验表明对患者没有额外益处。然而，迄今为止这些试验中报告的复发例数不多，且各个试验的结果存在异质性。此外，由于他莫昔芬的“延续”效应，疗程试验需要相当长的随访时间才能得出明确结果。在获得更确切的数据之前，在临床试验环境之外，他莫昔芬的辅助治疗应限制在5年。持续将ER阳性患者纳入正在进行的他莫昔芬疗程试验，包括辅助性他莫昔芬更多治疗（aTTom）试验和辅助性他莫昔芬长疗程与短疗程对比（ATLAS）试验，是合适的。或者，对于他莫昔芬治疗5年后仍无疾病的患者，应鼓励他们参与试验，测试交叉使用其他激素干预措施，包括选择性ER调节剂或芳香化酶抑制剂。
