Switching of postmenopausal women with endocrine-responsive early breast cancer to anastrozole after 2 years' adjuvant tamoxifen: combined results of ABCSG trial 8 and ARNO 95 trial
Switching of postmenopausal women with endocrine-responsive early breast cancer to anastrozole after 2 years' adjuvant tamoxifen: combined results of ABCSG trial 8 and ARNO 95 trial
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DOI：
10.1016/s0140-6736(05)67059-6
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发表时间：
2005-08-06
期刊：
影响因子：
168.9
通讯作者：
Kaufmann, M
中科院分区：
文献类型：
--
作者：
Jakesz, R;Jonat, W;Kaufmann, M
背景他莫昔芬作为绝经后妇女对化疗敏感的早期乳腺癌的标准辅助治疗已有20多年。然而，第三代芳香化酶抑制剂阿那曲唑已被证明的疗效和耐受性的好处相比，他莫昔芬时，作为初始辅助治疗。我们调查妇女谁接受了一段时间的辅助他莫昔芬将受益于被切换到anastrozolazo.Methods我们提出了一个综合分析的数据从两个前瞻性的，多中心的，随机的，开放标签的试验，几乎相同的纳入标准。绝经后妇女对阿那曲唑敏感的早期乳腺癌患者完成了2年的辅助口服他莫昔芬（20或30 mg/d），随机接受1 mg口服阿那曲唑（n=1618）或20或30 mg他莫昔芬（n=1606），用于剩余的辅助治疗。主要终点是无事件生存期，事件定义为局部或远处转移或对侧乳腺癌。结果3224例患者纳入分析。在中位随访28个月时，我们注意到与他莫昔芬组相比，阿那曲唑组的事件风险降低了40%（阿那曲唑组67起事件vs他莫昔芬组110起事件，风险比0.60，95%CI 0.44-0.81，p=0.0009）。两种研究治疗均耐受良好。有显着更多的骨折（p=0.015）和显着较少的血栓形成（p=0.034），在接受阿那曲唑治疗的患者比那些在tamoxifen.Interpretation这些数据提供支持，从他莫昔芬阿那曲唑的患者谁已经完成了2年的辅助他莫昔芬开关。
Background Tamoxifen has been the standard adjuvant treatment for postmenopausal women with hormone-responsive early breast cancer for more than 20 years. However, the third-generation aromatase inhibitor anastrozole has proven efficacy and tolerability benefits compared with tamoxifen when used as initial adjuvant therapy. We investigate whether women who have received a period of adjuvant tamoxifen would benefit from being switched to anastrozole.Methods We present a combined analysis of data from two prospective, multicentre, randomised, open-label trials with nearly identical inclusion criteria. Postmenopausal women with hormone-sensitive early breast cancer who had completed 2 years' adjuvant oral tamoxifen (20 or 30 mg daily) were randomised to receive 1 mg oral anastrozole (n=1618) or 20 or 30 mg tamoxifen (n=1606) daily for the remainder of their adjuvant therapy. The primary endpoint was event-free survival, with an event defined as local or distant metastasis, or contralateral breast cancer. Analysis was by intention to treat.Findings 3224 patients were included in analyses. At a median follow-up of 28 months, we noted a 40% decrease in the risk for an event in the anastrozole group as compared with the tamoxifen group (67 events with anastrozole vs 110 with tamoxifen, hazard ratio 0.60, 95% CI 0.44-0.81, p=0.0009). Both study treatments were well tolerated. There were significantly more fractures (p=0.015) and significantly fewer thromboses (p=0.034) in patients treated with anastrozole than in those on tamoxifen.Interpretation These data lend support to a switch from tamoxifen to anastrozole in patients who have completed 2 years' adjuvant tamoxifen.