Delozier T, Switsers O, Génot J Y, Ollivier J M, Héry M, Namer M, Fresney M, Kerbrat P, Veyret C, de Lafontan B, Janvier M, Macé-Lesech J
Centre François Baclesse, Caen, France.
Ann Oncol. 2000 May;11(5):515-9. doi: 10.1023/a:1008321415065.
Immediate adjuvant tamoxifen reduces disease recurrence and improves survival in patients with early breast cancer. However, is it too late to administer tamoxifen to patients who have already undergone treatment, but were unable to benefit from this adjuvant therapy? The French National Cancer Centers (FNCLCC) have investigated the efficacy of delayed tamoxifen administration in a randomized controlled trial.
From September 1986 to October 1989, women with primary breast cancer, who had undergone surgery, radiotherapy, and/or received adjuvant chemotherapy but not hormone therapy more than two years earlier, were randomized to receive either 30 mg/day tamoxifen or no treatment. The 10-year disease-free and overall survival rates of the two groups of patients and of various subgroups were determined according to the Kaplan-Meyer method and compared by the log-rank test.
This intention-to-treat analysis comprised 250 Introduction women in the tamoxifen group and 244 in the control group. Patient characteristics (age, T stage, number of positive nodes, receptor status, and interval since tumor treatment) were comparable in both groups. Delayed adjuvant tamoxifen significantly improved overall survival only in node-positive patients and in patients with estrogen receptor-positive (ER+) or progesterone receptor-positive (PR+) tumors. Disease-free survival, however, was significantly improved in the global population and in several patient subgroups (node-positive, ER+, PR+). Patients in whom the interval between primary treatment and delayed adjuvant tamoxifen was greater than five years also had significantly improved disease-free survival.
Overall and disease-free survival results indicate that delayed adjuvant tamoxifen administration (30 mg/day) is justified in women with early breast cancer, even if this treatment is initiated two or more years after primary treatment.
早期乳腺癌患者立即使用他莫昔芬辅助治疗可降低疾病复发率并提高生存率。然而，对于那些已经接受过治疗但未能从这种辅助治疗中获益的患者，给予他莫昔芬是否为时已晚？法国国家癌症中心（FNCLCC）在一项随机对照试验中研究了延迟使用他莫昔芬的疗效。
从1986年9月至1989年10月，将患有原发性乳腺癌且已接受手术、放疗和/或辅助化疗但超过两年未接受激素治疗的女性随机分为两组，一组接受每日30毫克他莫昔芬治疗，另一组不接受治疗。根据Kaplan - Meyer方法确定两组患者及各亚组的10年无病生存率和总生存率，并通过对数秩检验进行比较。
这项意向性分析包括他莫昔芬组的250名女性和对照组的244名女性。两组患者的特征（年龄、T分期、阳性淋巴结数量、受体状态以及肿瘤治疗后的时间间隔）具有可比性。延迟使用他莫昔芬辅助治疗仅在淋巴结阳性患者以及雌激素受体阳性（ER +）或孕激素受体阳性（PR +）肿瘤患者中显著提高了总生存率。然而，在总体人群以及几个患者亚组（淋巴结阳性、ER +、PR +）中，无病生存率显著提高。原发性治疗与延迟使用他莫昔芬辅助治疗之间的时间间隔大于五年的患者，其无病生存率也显著提高。
总生存率和无病生存率结果表明，对于早期乳腺癌女性患者，延迟给予他莫昔芬辅助治疗（每日30毫克）是合理的，即使这种治疗在原发性治疗两年或更长时间后开始。
