A comparison of letrozole and tamoxifen in postmenopausal women with early breast cancer.
A comparison of letrozole and tamoxifen in postmenopausal women with early breast cancer.
复制标题
来曲唑和他莫昔芬在患有早期乳腺癌的绝经后妇女中的比较。
DOI：
10.1056/nejmoa052258
复制
发表时间：
2005
期刊：
影响因子：
--
通讯作者：
A. Goldhirsch
中科院分区：
文献类型：
--
作者：
B. Thürlimann;A. Keshaviah;A. Coates;H. Mouridsen;L. Mauriac;J. Forbes;R. Paridaens;M. Castiglione‐Gertsch;R. Gelber;M. Rabaglio;I. Smith;A. Wardley;K. Price;A. Goldhirsch
背景
芳香酶抑制剂来曲唑是一种更有效的转移性乳腺癌治疗方法，在新辅助治疗中比他莫昔芬更有效。我们比较了来曲唑和他莫昔芬作为绝经后妇女激素受体阳性乳腺癌的辅助治疗。
方法
乳腺国际组织(BIG)1-98研究是一项随机、3期、双盲试验，对激素受体阳性的绝经后妇女使用不同的内分泌辅助治疗方案进行了5年的治疗比较：来曲唑、来曲唑、他莫昔芬和来曲唑。这项分析比较了最初被分配接受来曲唑的两组和最初被分配接受他莫昔芬的两组；序贯治疗组中的事件和随访包括直到治疗切换的时间。
结果
共有8010名数据可以评估的女性入选，其中来曲唑组4003名，他莫昔芬组4007名。经过25.8个月的中位随访，来曲唑组和他莫昔芬组分别发生了351个事件和428个事件，5年无瘤生存率估计分别为84.0%和81.4%。与他莫昔芬相比，来曲唑显著降低了事件结束无病生存期的风险(风险比0.81；95%可信区间0.70至0.93；P=0.003)，特别是远处复发的风险(风险比0.73；95%可信区间0.60至0.88；P=0.001)。血栓栓塞症、子宫内膜癌和阴道出血在他莫昔芬组中更为常见。服用来曲唑的女性骨骼和心脏事件以及高胆固醇血症的发生率更高。
结论
在患有内分泌反应型乳腺癌的绝经后妇女中，与他莫昔芬相比，来曲唑辅助治疗降低了复发的风险，特别是在遥远的部位。(ClinicalTrials.gov编号，NCT00004205。)
BACKGROUND
The aromatase inhibitor letrozole is a more effective treatment for metastatic breast cancer and more effective in the neoadjuvant setting than tamoxifen. We compared letrozole with tamoxifen as adjuvant treatment for steroid-hormone-receptor-positive breast cancer in postmenopausal women.
METHODS
The Breast International Group (BIG) 1-98 study is a randomized, phase 3, double-blind trial that compared five years of treatment with various adjuvant endocrine therapy regimens in postmenopausal women with hormone-receptor-positive breast cancer: letrozole, letrozole followed by tamoxifen, tamoxifen, and tamoxifen followed by letrozole. This analysis compares the two groups assigned to receive letrozole initially with the two groups assigned to receive tamoxifen initially; events and follow-up in the sequential-treatment groups were included up to the time that treatments were switched.
RESULTS
A total of 8010 women with data that could be assessed were enrolled, 4003 in the letrozole group and 4007 in the tamoxifen group. After a median follow-up of 25.8 months, 351 events had occurred in the letrozole group and 428 events in the tamoxifen group, with five-year disease-free survival estimates of 84.0 percent and 81.4 percent, respectively. As compared with tamoxifen, letrozole significantly reduced the risk of an event ending a period of disease-free survival (hazard ratio, 0.81; 95 percent confidence interval, 0.70 to 0.93; P=0.003), especially the risk of distant recurrence (hazard ratio, 0.73; 95 percent confidence interval, 0.60 to 0.88; P=0.001). Thromboembolism, endometrial cancer, and vaginal bleeding were more common in the tamoxifen group. Women given letrozole had a higher incidence of skeletal and cardiac events and of hypercholesterolemia.
CONCLUSIONS
In postmenopausal women with endocrine-responsive breast cancer, adjuvant treatment with letrozole, as compared with tamoxifen, reduced the risk of recurrent disease, especially at distant sites. (ClinicalTrials.gov number, NCT00004205.)
影响因子：
39.2
作者：
S. Legha
通讯作者：
S. Legha
DOI：
10.1093/jnci/93.1.16
发表时间：
2001-01-03
期刊：
JOURNAL OF THE NATIONAL CANCER INSTITUTE
影响因子：
--
作者：
Reis, SE;Costantino, JP;Kavanah, M
通讯作者：
Kavanah, M