ADC类药物治疗乳腺癌疗效与安全性的Meta分析

Efficacy and safety of antibody-drug conjugates in the treatment of breast cancer:a meta-analysis

目的评价抗体药物偶联物(ADC)类药物治疗乳腺癌的疗效和安全性,为临床用药提供循证依据。方法计算机检索中国知网、万方数据库、维普网、PubMed、the Cochrane Library、Embase、Web of Science,收集恩美曲妥珠单抗、德曲妥珠单抗和戈沙妥珠单抗(试验组)对比化疗药物或其他抗肿瘤药物(对照组)的随机对照试验(RCT),检索时限为建库起至2023年4月。筛选文献,提取资料并评价文献质量后,采用RevMan 5.4.1软件进行Meta分析。结果共纳入8项RCT,共计5577例患者。Meta分析结果显示,试验组患者的无进展生存期(PFS)[HR=0.76,95%CI(0.69,0.83),P<0.00001]、总生存期(OS)[HR=0.87,95%CI(0.81,0.93),P<0.0001]、临床获益率(CBR)[OR=2.70,95%CI(1.15,6.33),P=0.02]均显著长于/高于对照组;两组患者的客观缓解率(ORR)比较,差异无统计学意义[OR=2.34,95%CI(0.59,9.33),P=0.23]。亚组分析结果显示,试验组人表皮生长因子受体-2(HER2)阳性、HER2阴性患者的PFS以及HER2阳性患者的OS均显著高于对照组(P<0.05)。试验组患者的贫血、天冬氨酸转氨酶升高发生率均显著高于对照组(P<0.05)。敏感性分析结果显示,以PFS、OS、ORR为指标时,所得结果较稳健;以CBR为指标时,所得结果缺乏稳健性。结论ADC类药物用于乳腺癌的疗效显著,但会增加贫血和天冬氨酸转氨酶升高的发生风险。

OBJECTIVE To evaluate the efficacy and safety of antibody-drug conjugates(ADC)in the treatment of breast cancer,so as to provide an evidence-based reference for clinical medication.METHODS Retrieved from CNKI,Wanfang database,VIP,PubMed,the Cochrane Library,Embase,and Web of Science,randomized controlled trials(RCTs)about trastuzumab emtansine,trastuzumab deruxtecan and sacituzumab govitecan(trial group)versus chemotherapy or other anti-tumor drugs(control group),were collected during the inception to April 2023.After screening the literature,extracting data,and evaluating the quality of the literature,a meta-analysis was conducted by using RevMan 5.4.1 software.RESULTS A total of 8 RCTs were included,with a total of 5577 patients.The results of the meta-analysis showed that the progression-free survival(PFS)[HR=0.76,95%CI(0.69,0.83),P<0.00001],overall survival(OS)[HR=0.87,95%CI(0.81,0.93),P<0.0001],and clinical benefit rate(CBR)[OR=2.70,95%CI(1.15,6.33),P=0.02]of the trial group were significantly higher than control group.There was no statistically significant difference in objective response rate(ORR)between the two groups[OR=2.34,95%CI(0.59,9.33),P=0.23].The results of subgroup analysis showed that the PFS of HER2-positive patients and HER2-negative patients,and the OS of HER2-positive patients in the trial group were significantly higher than control group(P<0.05).The incidence of anemia and increase of aspartic acid transaminase(AST)in the trial group was significantly higher than control group(P<0.05).The results of sensitivity analysis showed that the results obtained with PFS,OS,and ORR as indicators were relatively robust,while the results obtained with CBR as indicators lacked robustness.CONCLUSIONS ADC drugs have significant effects on breast cancer,but will increase the risk of anemia and elevated AST.