A randomized trial of exemestane after two to three years of tamoxifen therapy in postmenopausal women with primary breast cancer
A randomized trial of exemestane after two to three years of tamoxifen therapy in postmenopausal women with primary breast cancer
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DOI：
10.1056/nejmoa040331
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发表时间：
2004-03-11
影响因子：
158.5
通讯作者：
Bliss, JM
中科院分区：
文献类型：
--
作者：
Coombes, RC;Hall, E;Bliss, JM
背景：他莫昔芬服药5年，是绝经后女性雌激素受体阳性乳腺癌的标准辅助治疗药物。方法：我们进行了一项双盲随机试验，以测试在两到三年的三苯氧胺治疗后，在接下来的五年治疗中，改用依西美坦是否比继续使用他莫昔芬更有效。结果：在登记的4742名患者中，2362名患者被随机分配改用依西美坦，2380名患者继续接受他莫昔芬治疗。经过平均30.6个月的随访，报告了449例首次事件(局部或转移性复发、对侧乳腺癌或死亡)--依西美坦组183例，他莫昔芬组266例。依西美坦组与三苯氧胺组相比，未调整风险比为0.68(95%可信区间为0.56~0.82；P
BACKGROUND:Tamoxifen, taken for five years, is the standard adjuvant treatment for postmenopausal women with primary, estrogen-receptor-positive breast cancer. Despite this treatment, however, some patients have a relapse.METHODS:We conducted a double-blind, randomized trial to test whether, after two to three years of tamoxifen therapy, switching to exemestane was more effective than continuing tamoxifen therapy for the remainder of the five years of treatment. The primary end point was disease-free survival.RESULTS:Of the 4742 patients enrolled, 2362 were randomly assigned to switch to exemestane, and 2380 to continue to receive tamoxifen. After a median follow-up of 30.6 months, 449 first events (local or metastatic recurrence, contralateral breast cancer, or death) were reported -- 183 in the exemestane group and 266 in the tamoxifen group. The unadjusted hazard ratio in the exemestane group as compared with the tamoxifen group was 0.68 (95 percent confidence interval, 0.56 to 0.82; P