Fisher B, Brown A, Wolmark N, Redmond C, Wickerham D L, Wittliff J, Dimitrov N, Legault-Poisson S, Schipper H, Prager D
Ann Intern Med. 1987 May;106(5):649-54. doi: 10.7326/0003-4819-106-5-649.
To determine whether prolonging the duration of tamoxifen administration beyond the cessation of a combined chemotherapy regimen benefits patients with primary breast cancer with positive findings in axillary nodes who benefit initially from the combined regimen.
Nonrandomized, nonconcurrent cohort study.
National Surgical Adjuvant Breast and Bowel Project, conducted in 68 institutions in North America.
Women were included if they had breast cancer with positive nodes and were aged 49 years or less with both estrogen and progesterone receptor levels of 10 fmol or more, aged 50 to 59 years with progesterone receptor levels of 10 fmol or more, or aged 60 to 69 years. Two cohorts were compared: patients who were randomly assigned to the tamoxifen arm of the adjuvant chemotherapy trial (randomized patients) and women who were added to this arm after randomization had ceased (registered patients). Three hundred seventy-seven women in each group who were disease free at the end of the initial 2-year treatment period were followed for an additional 3 years.
All received melphalan, fluorouracil, and tamoxifen (10 mg twice daily by mouth) for 2 years. Registered patients (but not randomized patients) were offered tamoxifen for a third year after the initial 2-year treatment period, and 273 (72%) agreed.
Women receiving a third year of tamoxifen had a better disease-free survival rate (odds ratio, 1.54; 95% confidence interval, 1.14 to 2.07; p = 0.004) and survival rate (odds ratio, 1.56; 95% Cl, 1.02 to 2.37; p = 0.04) through their fifth postoperative year. Women aged 50 years or more benefited, but those aged 49 years or less did not.
The benefit of tamoxifen given to tamoxifen-responsive patients in conjunction with melphalan and fluorouracil appears to be enhanced when the tamoxifen treatment is continued beyond cessation of treatment with these agents.
确定在联合化疗方案结束后延长他莫昔芬给药时间是否对最初从联合方案中获益的腋窝淋巴结阳性的原发性乳腺癌患者有益。
非随机、非同期队列研究。
北美68家机构开展的国家乳腺与肠道外科辅助治疗项目。
纳入标准为患有淋巴结阳性乳腺癌的女性，年龄49岁及以下且雌激素和孕激素受体水平均为10 fmol或更高，年龄50至59岁且孕激素受体水平为10 fmol或更高，或年龄60至69岁。比较两个队列：随机分配至辅助化疗试验他莫昔芬组的患者（随机分组患者）和随机分组结束后加入该组的女性（登记患者）。每组中在初始2年治疗期结束时无疾病的377名女性再随访3年。
所有人接受美法仑、氟尿嘧啶和他莫昔芬（口服10 mg，每日两次）治疗2年。登记患者（而非随机分组患者）在最初2年治疗期后可选择接受第3年的他莫昔芬治疗，273名（72%）患者同意。
接受第3年他莫昔芬治疗的女性在术后第5年的无病生存率（优势比，1.54；95%置信区间，1.14至2.07；p = 0.004）和生存率（优势比，1.56；95% Cl，1.02至2.37；p = 0.04）更好。50岁及以上的女性获益，但49岁及以下的女性未获益。
对于对他莫昔芬有反应的患者，在使用美法仑和氟尿嘧啶治疗结束后继续使用他莫昔芬，似乎可增强其疗效。
