赫赛汀联合辅助化疗对人类表皮生长因子受体2阳性早期乳腺癌患者预后影响的Meta分析

Herceptin plus adjuvant chemotherahy for the prognosis of patients with human epithelial growth factor receptor 2 positive early-stage breast cancer: a Meta-analysis

目的:应用meta分析的方法探讨赫赛汀(曲妥珠单抗)联合辅助化疗对人类表皮生长因子受体2(HER2)阳性早期乳腺癌患者预后的影响。方法:在MEDLINE,EMBase,Cochrane图书馆,临床试验注册库,google学术网,中国医院数字化图书馆,维普、万方数据库,历年美国临床肿瘤学会会议资料及欧洲灰色情报系统(SIGLE)中检索有关HER2阳性早期乳腺癌患者赫赛汀联合辅助化疗的前瞻性随机对照临床试验,按Meta分析软件(RevMan4.2)要求处理有关数据。结果:从1996～2006年共有4项研究入选,合并后试验组共有4555例,对照组共有4561例。分析结果显示赫赛汀联合辅助化疗与单纯辅助化疗相比,无病生存率RR=1.08(95%CI,1.06～1.09),P<0.001;总体生存率RR=1.01(95%CI,1.01～1.02),P=0.0003;远处复发率RR=0.49(95%CI,0.42～0.57),P<0.001;心脏事件发生率RR=3.93(95%CI,1.03～15.06),差异均有统计学意义(P=0.05)。结论:赫赛汀联合辅助化疗治疗HER2阳性早期乳腺癌能够显著提高患者的无病生存率、总体生存率,降低远期复发率,但可能有心脏毒性作用,心脏毒性在联用蒽环类药物(阿霉素)后尤为明显。

Objective To evaluate the effect of herceptin （transtuzumab） plus adjuvant chemotherapy on the prognosis of patients with human epithelial growth factor receptor 2 （ HER2 ） positive early-stage breast cancer by Meta-analysis. Methods Search all of randomized clinical trials （RCTs） on herceptin plus adjuvant chemotherapy for HER2 positive early-stage breast cancer in MEDLINE, EMBase, Cochrane library, Clinical Trails, ASCO Conference data, CHKD, Wanfang Database, VIP information, scholar, google, com and SIGLE. A Meta-analysis was carried out by collecting information based on the inclusion and exclusion criteria from all papers available. Results The Meta- analysis 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 （herceptin plus adjuvant chemotherapy ） and the control group （adiuvant chemotherapy ） in the disease-free survival rate [ relative risk （RR） = 1. 08, 95% CI, 1. 06 - 1. 09, P 〈 0.001], the overall survival rate（RR = 1.01, 95% CI, 1.01 - 1.02, P=0.0003）, the distant recurrence rate（RR =0.49, 95% CI, 0.42 -0.57, P 〈0.001）, and the cardiac events rate （RR = 3.93,95% CI, 1.03 - 15.06, P = 0.05）. Conclusion Herceptin plus adjuvant chemotherapy can improve the disease-free survival rate and the overall survival rate, decrease distant recurrence rate of patients with HER2 positive early-stage breast cancer, but may cause heart toxicity, especially when combined with anthracycline （doxorubicin）.