Late extended adjuvant treatment with letrozole improves outcome in women with early-stage breast cancer who complete 5 years of tamoxifen
Late extended adjuvant treatment with letrozole improves outcome in women with early-stage breast cancer who complete 5 years of tamoxifen
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DOI：
10.1200/jco.2007.11.6798
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发表时间：
2008-04-20
影响因子：
45.3
通讯作者：
Tu, Dongsheng
中科院分区：
文献类型：
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作者：
Goss, Paul E.;Ingle, James N.;Tu, Dongsheng
目的加拿大国家癌症研究所临床试验组。17项试验检测了来曲唑（LET）在绝经后激素受体阳性的早期乳腺癌的5年辅助他莫昔芬治疗后3个月内开始使用的疗效。当试验非盲时，接受安慰剂（placc）的患者被给予LET。患者和方法本队列分析描述了在解盲后最初随机分配的妇女的结果。通过风险比和Cox模型计算的P值（校正组间不平衡），比较选择LET （placa -LET组）和未选择LET （placa - placc组）的妇女的疗效结果。毒性分析仅包括解盲后发生的事件。结果place - let组有1579例（停用他莫昔芬的中位时间为2.8年），place - plac组有804例。placa - let组患者较年轻；业绩状态较好；与PLAC-PLAC组相比，他们更有可能患有淋巴结阳性疾病、腋窝清扫和辅助化疗。中位随访5.3年，无病生存率（DFS），校正风险比[HR]， 0.37; 95% CI, 0.23 ~ 0.61
PurposeThe National Cancer Institute of Canada Clinical Trials Group MA. 17 trial examined the efficacy of letrozole (LET) started within 3 months of 5 years of adjuvant tamoxifen in postmenopausal hormone receptor-positive early-stage breast cancer. When the trial was unblinded, patients who received placebo (PLAC) were offered LET.Patients and MethodsThis cohort analysis describes the outcomes of women assigned PLAC at the initial random assignment after unblinding. Efficacy outcomes of women who chose LET (PLAC-LET group) were compared with those who did not (PLAC-PLAC group) by the hazard ratios and by P values calculated from Cox models that adjusted for imbalances between the groups. Toxicity analyses included only events that occurred after unblinding.ResultsThere were 1,579 women in the PLAC-LET group (median time from tamoxifen, 2.8 years) and 804 in the PLAC-PLAC group. Patients in the PLAC-LET group were younger; had a better performance status; and were more likely to have had node-positive disease, axillary dissection, and adjuvant chemotherapy than those in the PLAC-PLAC group. At a median follow-up of 5.3 years, disease-free survival (DFS; adjusted hazard ratio [ HR], 0.37; 95% CI, 0.23 to 0.61; P