托瑞米芬与他莫昔芬治疗围绝经期与绝经期乳腺癌
| 作者: |
1闫涵,
1张瑞雪,
1李琴,
1杨薏帆,
1肖婧,
1刘文婷,
1曹邦伟
1 首都医科大学附属北京友谊医院肿瘤科，北京 100050 |
| 通讯: |
曹邦伟
Email: oncologychina@163.com |
| DOI: | 10.3978/j.issn.2095-6959.2014.06.016 |
| 基金: | 国家自然科学基金, H1609 北京市“215”高层次卫生人才资助项目(2011-3-007)，北京市“十百千”人才资 助项目, 2010-9-6 |
摘要
目的：评价托瑞米芬(toremifene，TOR)与他莫昔芬(tamoxifen，TAM)在治疗围绝经期与绝经期乳腺癌的 有效性与安全性差异。方法：检索PubMed、EMBASE及Web of Science中公开发表的TOR与TAM有效与 安全性相关英文文献，文献类型限制为随机对照临床试验(randomized controlled trial，RCT)；采用Jadad 评分标准评价文献质量；系统评价采用Cochrane协作网提供的RevMan5.0软件完成；研究结果的分析根 据异质性检验结果，采用固定效应模型(fixed effects model，FEM)或随机效应模型(random effects model， REM)进行分析。结果：8项纳入的RCT的系统评价结果显示，TOR远期疗效与TAM相似，即TAM组 与TOR组的总生存时间(overall survival，OS)、疾病进展时间(time to progression，TTP)及5年无病生存率 (disease-free survival，DFS)没有显著差异(OS：HR=1.00，95% CI：0.85~1.16；TTP：HR=0.93，95% CI： 0.81~1.06；5年DFS：OR=1.11，95% CI：0.88~1.40)，5年总生存率TOR组优于TAM组，OR=1.26，95% CI：1.04~1.53，P=0.02；TOR临床不良反应的发生率与TAM相似，但在某些不良事件的发生率，如眼毒 性及血管栓塞事件的发生率低于TAM。结论：TOR与TAM在治疗围绝经期与绝经期乳腺癌的疗效与安 全性相似，TOR远期预后可能优于TAM。
关键词：
托瑞米芬
他莫昔芬
系统评价
The efficacy and safety of toremifene versus tamoxifen in the treatment of perimenopausal and postmenopausal breast cancer: a system assessment
CorrespondingAuthor: CAO Bangwei Email: oncologychina@163.com
DOI: 10.3978/j.issn.2095-6959.2014.06.016
Abstract
Objective: The efficacy and safety of toremifene in adjuvant endocrine therapy for perimenopausal and postmenopausal breast cancer still not very clear, compared with tamoxifen. The purpose of this meta-analysis was to assess the efficacy and side effects of toremifene versus tamoxifen in the treatment of perimenopausal and postmenopausal breast cancer. Methods: PubMed, EMBASE as well as Web of Science database were searched for relevant RCTs comparing the efficacy and safety of toremifene with tamoxifen. Jadad scale was used to evaluate the quality of the trials. The result of this systems assessment was pooled by RevMan5.0 software. Fixed effect model or random effect model was chosen depending on the heterogeneity. Overall survival (OS), progression-free survival (PFS), response rate (RR) are evaluated as the outcomes in our analysis. The toxicities included nausea and vomiting, vagina discharge, hot flash, vagina bleeding, ophthalmological and thromboembolic events. Results: Eight randomized trials including 5 734 cases published in the three articles were eligible. OS time to progression (TTP) and 5-year disease-free-survival rates was not significantly different between tamoxifen group and toremifene group (OS: HR=1.00, 95% CI: 0.85~1.16; TTP: HR=0.93, 95% CI: 0.81~1.06; 5-year DFS: OR=1.11, 95% CI: 0.88~1.40. The results meta-analyses showed toremifene significantly increased 5-year overall survival rates compared with tamoxifen (OR=1.26, 95% CI: 1.04~1.53, P=0.02). The incidence of nausea and vomiting, hot flash and vagina bleeding between the two groups were similar. The incidence of the ophthalmological (OR: 0.63, 95% CI: 0.46~0.85, P=0.003) and thromboembolic (OR: 0.69, 95% CI: 0.54~0.90, P=0.006) events in the toremifene group were higher compared with the tamoxifen group. The incidence of vagina discharge was higher in toremifene group (OR: 1.30, 95% CI: 1.04~1.63, P=0.02). Conclusion: The efficacy and safety of toremifene is similar to tamoxifen in the treatment of perimenopausal and postmenopausal breast cancer. The long-term prognosis of toremifene may be better than tamoxifen.