摘要
目的应用Meta分析的方法探讨曲妥珠单抗对HER2阳性早期乳腺癌患者预后的影响。材料和方法在MEDLINE,EMBASE,Cochrane图书馆,临床试验登记网,历年美国临床肿瘤学会会议资料,中国数字医院全文数据库,维普数据库及Google检索有关HER2阳性早期乳腺癌患者曲妥珠单抗联合辅助化疗的前瞻性随机对照研究,按Meta分析软件要求评价和处理有关数据。结果1996-2006年共有4项研究入选,试验组共有4555例,对照组共有4561例。分析结果显示曲妥珠单抗联合辅助化疗与单纯辅助化疗相比,无病生存率的相对危险度RR=1.08(95%CI1.06～1.09),P<0.00001;总体生存率的相对危险度RR=1.01(95%CI1.01～1.02),P=0.0003;远处复发率相对危险度RR=0.49(95%CI0.42～0.57),P<0.00001;心脏事件发生率相对危险度RR=3.93(95%CI1.03～15.06),P=0.05,差异有统计学意义。结论曲妥珠单抗联合辅助化疗治疗HER2阳性早期乳腺癌能够显著提高患者的无病生存率,降低远期复发率,但对总体生存率并无明显改善,且可能有心脏毒性作用,尤其是联用蒽环类药物(阿霉素)后,需进一步研究证实。
Objective To evaluate the effects of Trastuzumab on the prognosis of HER2 positive patients with early-stage breast cancer by meta-analysis. Methods Search all of RCTs on Trastuzumab plus adjuvant chemotherapy for HER2 positive early-stage breast cancer in MEDLINE, EMBASE, Cochrane Library, ClinicalTrials, ASCO Conference data, CHKD , Wanfang Database, VIP information and scholar.google.com. A meta-analysis was carried out by collecting information based on inclusion and exclusion criteria from all papers available. Results The metaanalysis included 4 trials. A total of 9 116 patients were included in the analysis （4 555 in the study group and 4 561 in the control group）, There were statistical differences between the study group （Trastuzumab plus adjuvant chemotherapy） and the control group （adjuvant chemotherapy） in disease-free survival rate[relative risk（RR） 1.08, 95%CI 1.06 to 1.09, P〈0.000 01], in overall survival rate（RR 1.01, 95%CI 1.01 to 1.02, P=0.000 3）, in distant recurrence rate （RR 0.49, 95%CI 0.42 to 0.57,P〈0.000 01）, and in cardiac events rate [RR 3.93,95%CI 1.03 to 15.06,P=0.05] respectively. Conclusion Trastuzumab plus adjuvant chemotherapy can improve disease-free survival rate, decrease distant recurrence rate of patients with HER2 positive early-stage breast cancer, but shows no superior improvement in overall survival rate, and may cause heart toxicity, especially when it combined with anthracycline （Doxorubicin）, so further research is needed.
出处
《循证医学》
CSCD
2006年第6期352-356,共5页
The Journal of Evidence-Based Medicine
