主页 > 医药科学 >
【NEJM】女性乳腺癌中单用Letrozole与Tamoxifen+Letro
http://content.nejm.org/cgi/content/short/361/8/766
Letrozole Therapy Alone or in Sequence with Tamoxifen in Women with Breast Cancer
女性乳腺癌中单用Letrozole与Tamoxifen+Letrozole序贯治疗的3期临床随机盲法研究
ABSTRACT
Background 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.
Methods 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.
Results 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.
Conclusions 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 [ClinicalTrials.gov] .)
http://content.nejm.org/cgi/content/short/361/8/766
本人已认领该文编译，48小时后若未提交译文，请其他战友自由认领。 Letrozole Therapy Alone or in Sequence with Tamoxifen in Women with Breast Cancer
The BIG 1-98 Collaborative Group
女性乳腺癌中单用Letrozole与Tamoxifen+Letrozole序贯治疗的3期临床随机盲法研究
国际乳腺协作组
ABSTRACT
摘要
Background 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.
背景 芳香酶抑制剂来曲唑(letrozole)，与他莫昔芬(tamoxifen)相比，延长了绝经后激素受体阳性的早期女性乳腺癌患者的无病生存期。tamoxifen联合letrozole的序贯治疗是否优于单用letrozole治疗尚未有定论。
Methods 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.
方法 在这项随机，3期，双盲试验中，纳入的研究对象为绝经后激素受体阳性的女性乳腺癌患者，我们随机将这些研究对象分为5年tamoxifen单一疗法，5年letrozole单一疗法，或两者中任一种先用2年，剩余3年用两外一种。在6182例患者当中将序贯组与单用letrozole组进行比较，并且报告了在4922例患者当中单用letrozole与单用tamoxifen之间的特定条件下的最新分析研究。
Results 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.
阅读本文的人还阅读：
作者:admin@医学,生命科学 2010-10-29 05:11
医学,生命科学网