摘要
目的系统评价卡瑞利珠单抗联合阿帕替尼治疗三阴性乳腺癌的有效性和安全性。方法计算机检索PubMed、Web of Science、Embase、Cochrane Library、CNKI和WanFang Data数据库,搜集卡瑞利珠单抗联合阿帕替尼(联合组)或其与单用卡瑞利珠单抗(单一组)对比治疗三阴性乳腺癌的临床研究,检索时限均从建库至2024年6月10日。由2名研究者独立筛选文献、提取资料并评价纳入研究的偏倚风险后,采用RevMan 5.4.1及STATA 15软件进行Meta分析。结果共纳入6项研究,其中1项随机对照试验,2项队列研究,3项单臂试验,包括366例患者。Meta分析结果显示,联合组患者的客观缓解率(ORR)[OR=2.77,95%CI(1.60,4.81),P<0.001]及疾病控制率(DCR)[OR=2.27,95%CI(1.34,3.85),P=0.002]均显著高于单一组;单臂试验的结果显示,卡瑞利珠单抗联合阿帕替尼治疗后患者的总体ORR、DCR和无疾病进展期分别为28%[95%CI(0.04,0.52)]、65%[95%CI(0.37,0.92)]、5.66个月[95%CI(3.78,8.48)];联合组与单一组患者的白细胞减少发生率[OR=1.45,95%CI(0.50,4.17),P=0.49]、皮疹发生率[OR=1.11,95%CI(0.35,3.49),P=0.86];恶心呕吐发生率[OR=1.28,95%CI(0.36,4.61),P=0.70]差异均无统计学意义。结论现有证据表明,卡瑞利珠单抗联合阿帕替尼治疗三阴性乳腺癌具有协同效能,能改善细胞免疫功能,安全性可控。受纳入研究数量和质量的限制,上述结论尚需开展更多高质量的研究予以验证。
Objective To systematically review the efficacy and safety of camrelizumab and apatinib in the treatment of triple-negative breast cancer.Methods PubMed,Web of Science,Embase,Cochrane Library,CNKI,and WanFang Data databases were electronically searched to collect clinical studies of carelizumab combined with apatinib(combination group)or it vs.carelizumab alone(single group)in the treatment of triplenegative breast cancer from inception to June 14,2024.Two reviewers independently screened the literature,extracted data,and assessed the risk of bias in the included studies.Meta-analysis was performed by using RevMan 5.4.1 and STATA 15 softwares.Results A total of 6 studies were included,1 randomized controlled trial,2 cohort studies,and 3 single-arm trials,involving 366 patients.The results of the Meta-analysis indicated that the objective response rate(ORR)(OR=2.77,95%CI 1.60 to 4.81,P<0.001),and disease control rate(DCR)(OR=2.27,95%CI 1.34 to 3.85,P=0.002)in the combination group were significantly higher than those of the single group.The results of the single-arm trial showed that after the treatment of camrelizumab combined with apatinib,the ORR and DCR of the patients were 28%(95%CI 0.04 to 0.52)and 65%(95%CI 0.37 to 0.92),respectively.The overall progression-free survival of the patients after the combined treatment was 5.66 months(95%CI 3.78 to 8.48).The incidences of leukopenia(OR=1.45,95%CI 0.50 to 4.17,P=0.49),rash(OR=1.11,95%CI 0.35 to 3.49,P=0.86),nausea and vomiting(OR=1.28,95%CI 0.36 to 4.61,P=0.70)were not statistically significantly between the combination group and the single group.Conclusion Current evidence shows that carilizumab combined with apatinib has synergistic efficacy in treating triple-negative breast cancer,improves cellular immune function,and has a controllable safety profile.Due to the limitations of the number and quality of studies included,the above conclusion still needs to be verified by more high-quality studies.
作者
牛钊峰
翟杨海
耿睿
NIU Zhaofeng;ZHAI Yanghai;GENG Rui(Department of Breast Health,Yuncheng Maternal and Child Health Hospital in Shanxi Province,Yuncheng 044000,Shanxi Province,China;Department of Breast,Yuncheng Central Hospital in Shanxi Province,Yuncheng 044000,Shanxi Province,China)
出处
《药物流行病学杂志》
CAS
2024年第10期1137-1146,共10页
Chinese Journal of Pharmacoepidemiology
基金
2023年吴阶平医学基金会临床科研专项资助基金项目(320.6750.2023-18-30)。
作者简介
通信作者:耿睿,硕士,主治医师,Email:18935087181@163.com。
