摘要
目的：系统评价曲妥珠单抗辅助化疗治疗HER2阳性乳腺癌的有效性和安全性。方法：计算机检索国内外1996-2013年发表的曲妥珠单抗辅助化疗治疗HER2阳性乳腺癌的前瞻性随机对照临床试验（Rcts）研究,对符合纳入标准的研究以Jadad评分标准进行文献质量评价,并使用Review Manager 5.3软件进行Meta分析。结果：共纳入4项Ⅲ期Rcts（其中有两项Rcts为合并分析）。Meta分析结果显示,与单纯化疗相比,曲妥珠单抗联合化疗治疗HER2阳性乳腺癌可以显著延长患者的无病生存期DFS[HR=0.63,95%CI（0.50,0.81）,P〈0.001]和总生存期OS[HR=0.69,95%CI（0.56,0.86）,P=0.001]。在安全性方面,曲妥珠单抗联合化疗组心脏事件[RR=5.09,95%CI（3.23,8.03）,P〈0.00001]及充血性心力衰竭[RR=5.32,95%CI（2.28,12.44）,P=0.0001]发生率显著高于单纯化疗组,而在心脏事件导致的死亡方面,两组无显著差异。结论：曲妥珠单抗联合化疗治疗HER2阳性乳腺癌的疗效显著优于单纯化疗,但心脏事件也显著增加。
Objective： To systematically evaluate the efficacy and safety of trastuzumab in adjuvant therapy for HER2-positive breast cancer. Methods： Computerized search was performed to identify prospective random control trials published both in the domestic and overseas during 1996 to 2013 comparing adjuvant chemotherapy with or without trastuzumab in HER2-positive breast cancer patients. Jadad grading standard was used to appraise the quality of the included studies. Review Manager 5. 3 was used to conduct the Metaanalysis. Results： With 4 eligible Phase III clinical randomized controlled trials（ Rcts） identified（ 2 of them were joint analysis）,this analysis demonstrated that patients with HER2-positive breast cancer derived benefit in disease-free survival [HR = 0. 63,95% CI（ 0. 50,0. 81）,P〈0. 001],overall survival [HR = 0. 69,95% CI（ 0. 56,0. 86）,P = 0. 001]from the addition of trastuzumab to adjuvant chemotherapy,whereas trastuzumab bore a higher incidence of cardiac event[RR = 5. 09,95% CI（ 3. 23,8. 03）,P〈0. 00001] and congestive cardiac failure [RR = 5. 32,95% CI（ 2. 28,12. 44）,P = 0. 0001]as compared to the control group. However,the addition of trastuzumab made no significant difference in cardiac death. Conclusion： The curative effect of adjuvant trastuzumab is significantly better than chemotherapy alone in patients with HER2-positive breast cancer with cardiac toxicity increased.
出处
《中国药物评价》
2015年第1期35-40,共6页
Chinese Journal of Drug Evaluation
