Preoperative treatment of postmenopausal breast cancer patients with letrozole: A randomized double-blind multicenter study
Preoperative treatment of postmenopausal breast cancer patients with letrozole: A randomized double-blind multicenter study
复制标题
DOI：
10.1023/a:1013128213451
复制
发表时间：
2001-01-01
影响因子：
50.5
通讯作者：
Semiglazov, V
中科院分区：
文献类型：
--
作者：
Eiermann, W;Paepke, S;Semiglazov, V
背景资料：进行了一项随机、双盲、多中心研究，以比较来曲唑与他莫昔芬在绝经后ER和/或PgR阳性的原发性未治疗乳腺癌妇女中的抗肿瘤活性。患者和方法：337名绝经后ER和/或PgR阳性的原发性未治疗乳腺癌妇女被随机分配每日一次用来曲唑2.5 mg或他莫昔芬20 mg治疗4个月。在基线时，没有患者被认为是保乳手术（BCS）的候选人，14%的患者被认为是不可手术的。主要终点是比较通过临床触诊确定的总体客观缓解（CR + PR）。次要终点包括超声和乳腺X线检查的总体客观反应以及符合BCS条件的患者数量。结果：来曲唑组的总体客观反应率（临床触诊）在统计学上显著优于他莫昔芬组（上级，55%，36%）（P < 0.001）。来曲唑组和他莫昔芬组的次要终点超声反应率分别为35%和25%（P = 0.042），乳腺摄影反应率分别为34%和16%（P < 0.001），BCS分别为45%和35%（P = 0.022），显示来曲唑显著上级他莫昔芬。这两种治疗都是良好的tolerance.Conclusions：这项研究表明，来曲唑是更有效的比他莫昔芬作为术前治疗绝经后患者ER和/或PgR阳性的原发性未经治疗的乳腺癌，至少是耐受性良好。
Background: A randomized, double-blind, multicenter study was conducted to compare the anti-tumor activity of letrozole vs. tamoxifen in postmenopausal women with ER and/or PgR positive primary untreated breast cancer.Patients and methods: Three hundred thirty-seven postmenopausal women with ER and/or PgR positive primary untreated breast cancer were randomly assigned once daily treatment with either letrozole 2.5 mg or tamoxifen 20 mg for four months. At baseline none of the patients were considered to be candidates for breast-conserving surgery (BCS) and 14% of the patients were considered inoperable. The primary endpoint was to compare overall objective response (CR + PR) determined by clinical palpation. Secondary endpoints included overall objective response on ultrasound and mammography and the number of patients who qualified for BCS.Results: Overall objective response rate (clinical palpation) was statistically significantly superior in the letrozole group, 55% compared to tamoxifen, 36% (P < 0.001). Secondary endpoints of ultrasound response, 35% vs. 25% (P = 0.042), mammographic response, 34% vs. 16% (P < 0.001), and BCS, 45% vs. 35% (P = 0.022) between the letrozole and tamoxifen groups, respectively, showed letrozole to be significantly superior. Both treatments were well tolerated.Conclusions: This study shows that letrozole is more effective than tamoxifen as preoperative therapy in postmenopausal patients with ER and/or PgR positive primary untreated breast cancer and is at least as well tolerated.