Letrozole therapy alone or in sequence with tamoxifen in women with breast cancer.
Letrozole therapy alone or in sequence with tamoxifen in women with breast cancer.
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DOI：
10.1056/nejmoa0810818
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发表时间：
2009-08-20
期刊：
影响因子：
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通讯作者：
Coates AS
中科院分区：
文献类型：
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作者：
BIG 1-98 Collaborative Group;Mouridsen H;Giobbie-Hurder A;Goldhirsch A;Thürlimann B;Paridaens R;Smith I;Mauriac L;Forbes J;Price KN;Regan MM;Gelber RD;Coates AS
芳香化酶抑制剂来曲唑与他莫昔芬相比，可提高受体阳性早期乳腺癌绝经后妇女的无病生存率。目前尚不清楚他莫昔芬和来曲唑序贯治疗是否上级来曲唑单独治疗。在这项治疗绝经后妇女乳腺癌受体阳性的随机、3期、双盲试验中，我们将妇女随机分配接受5年他莫昔芬单药治疗、5年来曲唑单药治疗或2年一种药物治疗，随后3年另一种药物治疗。我们比较了6182名妇女接受来曲唑单药治疗的序贯治疗，并报告了4922名妇女接受来曲唑与他莫昔芬单药治疗的方案规定的最新分析。在随机分组后中位随访71个月时，与来曲唑单药治疗相比，两种序贯治疗均未显著改善无病生存率（他莫昔芬继来曲唑的风险比为1.05; 99%置信区间[CI]为0.84 - 1.32;来曲唑继他莫昔芬的风险比为0.96; 99% CI为0.76 - 1.21）。在接受他莫昔芬联合来曲唑治疗的妇女中，早期复发率高于单独接受来曲唑治疗的妇女。单药治疗的最新分析显示，来曲唑治疗组和他莫昔芬治疗组的总生存率无显著差异（来曲唑的风险比为0.87; 95%CI为0.75 - 1.02; P=0.08）。不良事件的发生率与先前来曲唑和他莫昔芬治疗报告的预期一致。在绝经后内分泌反应性乳腺癌患者中，与来曲唑单药治疗相比，来曲唑和他莫昔芬序贯治疗并不能提高无病生存率。来曲唑单药治疗和他莫昔芬单药治疗的总生存率差异无统计学意义。（ClinicalTrials.gov编号，NCT 00004205。）
The aromatase inhibitor letrozole, as compared with tamoxifen, improves disease-free survival among postmenopausal women with receptor-positive early breast cancer. It is unknown whether sequential treatment with tamoxifen and letrozole is superior to letrozole therapy alone. In this randomized, phase 3, double-blind trial of the treatment of hormone-receptor–positive breast cancer in postmenopausal women, we randomly assigned women to receive 5 years of tamoxifen monotherapy, 5 years of letrozole monotherapy, or 2 years of treatment with one agent followed by 3 years of treatment with the other. We compared the sequential treatments with letrozole monotherapy among 6182 women and also report a protocol-specified updated analysis of letrozole versus tamoxifen monotherapy in 4922 women. At a median follow-up of 71 months after randomization, disease-free survival was not significantly improved with either sequential treatment as compared with letrozole alone (hazard ratio for tamoxifen followed by letrozole, 1.05; 99% confidence interval [CI], 0.84 to 1.32; hazard ratio for letrozole followed by tamoxifen, 0.96; 99% CI, 0.76 to 1.21). There were more early relapses among women who were assigned to tamoxifen followed by letrozole than among those who were assigned to letrozole alone. The updated analysis of monotherapy showed that there was a nonsignificant difference in overall survival between women assigned to treatment with letrozole and those assigned to treatment with tamoxifen (hazard ratio for letrozole, 0.87; 95% CI, 0.75 to 1.02; P=0.08). The rate of adverse events was as expected on the basis of previous reports of letrozole and tamoxifen therapy. Among postmenopausal women with endocrine-responsive breast cancer, sequential treatment with letrozole and tamoxifen, as compared with letrozole monotherapy, did not improve disease-free survival. The difference in overall survival with letrozole monotherapy and tamoxifen monotherapy was not statistically significant. (ClinicalTrials.gov number, NCT00004205.)