Tamoxifen adjuvant treatment duration in early breast cancer:: Initial results of a randomized study comparing short-term treatment with long-term treatment
Tamoxifen adjuvant treatment duration in early breast cancer:: Initial results of a randomized study comparing short-term treatment with long-term treatment
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DOI：
10.1200/jco.2000.18.20.3507
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发表时间：
2000-10-15
影响因子：
45.3
通讯作者：
Namer, M
中科院分区：
文献类型：
--
作者：
Delozier, T;Spielmann, M;Namer, M
目的：在1986年，联邦国家中心治疗乳腺癌小组发起了一项多中心随机试验，以评估长期辅助他莫昔芬治疗的有效性。短期辅助他莫昔芬治疗wets比较终身辅助他莫昔芬treatment.Patients和方法：患者谁是无病后2至3年的辅助他莫昔芬治疗有资格参加试验。从1985年9月至1995年5月，从法国、比利时和阿根廷随机抽取了3,793例患者。共有1，882名患者停用他莫昔芬（短期组），1，911名患者终身继续使用他莫昔芬（长期组），剂量与先前处方相同。该方案于1997年2月进行了修改，将他莫昔芬治疗限制在随机化后10年，从而比较了2- 3年治疗和12- 13年治疗。到目前为止，他莫昔芬治疗的中位持续时间为30个月的短期组，70个月的长期group.Results：总体而言，较长的他莫昔芬治疗诱导复发率降低23%，导致7年无病生存率为78%，与72%相比，在较短的治疗组。相比之下，两组的总生存率没有差异，两组的总生存率均为79%。在淋巴结阳性患者中可以观察到无病生存率的改善（P = .001）;然而，在淋巴结阴性患者中没有发现。在雌激素受体阳性患者（P = 0.03）和雌激素受体阴性患者（P = 0.05）中，延长他莫昔芬治疗对应于无病生存率的显著增加。此外，较长的治疗减少对侧乳腺癌，并没有增加子宫内膜cancer.Conclusion的数量：虽然没有生存优势，注意到，患者受益于更长的他莫昔芬治疗超过3年，并有显着更好的无病生存期相比，停止激素治疗的患者。需要长期随访来评估这些结果。长期组的大多数患者仍在接受治疗。随着时间的推移，比较结果将能够得出结论，长期治疗超过5年的价值相比，2至3年。(C)2000年，美国临床肿瘤学会。
purpose: In 1986, The Federation Nationale des Centres de Lune Contre le Cancer Breast Group initiated a multicenter randomized trial to assess the usefulness of long-term adjuvant tamoxifen treatment. Short-term adjuvant tamoxifen treatment wets to be compared with lifelong adjuvant tamoxifen treatment.Patients and Methods: Patients who were disease-free after 2 to 3 years of adjuvant tamoxifen treatment were eligible for the trial. From September 1985 to May 1995, 3,793 patients were randomized from France, Belgium, and Argentina. A total of 1,882 patients stopped tamoxifen (short-term group), and 1,911 patients were to continue tamoxifen for life (long-term group) at the same dose as previously prescribed. The protocol was modified in February 1997, limiting tamoxifen treatment to 10 years after randomization, thus giving a comparison between a 2- to 3-year treatment and a 12- to 13-year treatment. To date, the median duration of tamoxifen treatment is 30 months in the short-term group, and 70 months in the long-term group.Results: Overall, longer tamoxifen treatment induced a 23% reduction in relapse rates, leading to a 7-year disease-free survival rate of 78%, compared with 72% in the shorter-treatment group. In contrast, overall survival did not differ between the two groups, with a 79% overall survival rate in both groups. This improvement in disease-free survival could be observed in node-positive patients (P = .001); however, it was not found in node-negative patients. Prolonged tamoxifen treatment corresponded to a significant increase in disease-free survival in estrogen receptor-positive patients (P = .03) as well as in estrogen receptor-negative patients (P = .05). Furthermore, longer treatment reduced contralateral breast cancers and did not increase the number of endometrial cancers.Conclusion: Although no survival advantage was noted, patients did benefit from longer tamoxifen treatment over 3 years and had significantly better disease-free survival compared with patients who stopped hormonal treatment. Long-term follow-up is needed to assess these results. Most patients in the long-term group are still receiving treatment. Comparison of results as time passes will enable conclusions to be made on the value of long-term treatment over 5 years compared with 2 to 3 years. (C) 2000 by American Society of Clinical Oncology.