卡博替尼治疗晚期甲状腺癌有效性和安全性的Meta分析  

Meta-analysis of efficacy and safety of cabozantinib in the treatment of advanced thyroid cancer

作　　者：竺晶 谢骥[2] 赵紫婷[1] 胡晓霞[1] ZHU Jing;XIE Ji;ZHAO Ziting;HU Xiaoxia(Dept.of Geriatrics,Lanzhou University Second Hospital,Lanzhou 730030,China;Dept.of Oncology,Lanzhou University Second Hospital,Lanzhou 730030,China)

机构地区：[1]兰州大学第二医院老年病科,兰州730030 [2]兰州大学第二医院肿瘤内科,兰州730030

出　　处：《中国药房》2023年第22期2800-2804,共5页China Pharmacy

摘　　要：目的评价卡博替尼治疗晚期甲状腺癌的有效性和安全性。方法计算机检索PubMed、the Cochrane Library、Embase、ClinicalTrials.gov、万方数据、维普网、中国知网、中国临床试验注册中心,收集卡博替尼(试验组)对比安慰剂(对照组)的随机对照试验(RCT),检索时限均为建库至2022年11月。筛选文献、提取资料及质量评价后,采用RevMan 5.4软件进行Meta分析。结果共纳入4项RCT,共计588例患者。Meta分析结果显示,试验组患者的无进展生存期(PFS)[HR=0.24,95%CI(0.19,0.31),P<0.00001]、客观缓解率(ORR)[RR=31.46,95%CI(6.32,156.75),P<0.0001]、3~4级不良事件(AE)[RR=2.15,95%CI(1.76,2.61),P<0.00001]、严重不良事件[RR=1.78,95%CI(1.11,2.83),P=0.02]、腹泻[RR=3.29,95%CI(1.62,6.66),P=0.001]、掌跖红斑感觉异常[RR=28.19,95%CI(12.25,64.88),P<0.00001]、高血压[RR=6.50,95%CI(3.90,10.83),P<0.00001]发生率均显著高于对照组,而两组患者的总生存期(OS)[HR=0.83,95%CI(0.67,1.02),P=0.07]、疲劳发生率[RR=1.25,95%CI(0.78,1.98),P=0.35]比较差异均无统计学意义。按不同肿瘤类型进行亚组分析结果显示,试验组分化型甲状腺癌、甲状腺髓样癌患者的PFS、ORR均显著高于对照组(P<0.05),其OS与对照组比较差异均无统计学意义(P>0.05)。结论卡博替尼可延长晚期甲状腺癌患者的PFS,增加ORR,但AE发生率较高。OBJECTIVE To review the efficacy and safety of cabozantinib in the treatment of advanced thyroid cancer.METHODS Retrieved from PubMed,the Cochrane Library,Embase,ClinicalTrials.gov,Wanfang data,VIP,CNKI and China Clinical Trials Registry,randomized controlled trials(RCTs)about cabozantinib(trial group)versus placebo(control group)were collected from the inception to Nov.2022.After literature screening,data extraction and quality evaluation,meta-analysis was performed by using RevMan 5.4 software.RESULTS A total of 4 RCTs were included involving 588 patients.The results of the meta-analysis showed that the progression free survival(PFS)[HR=0.24,95%CI(0.19,0.31),P<0.00001],objective response rate(ORR)[RR=31.46,95%CI(6.32,156.75),P<0.0001],the incidence of grade 3-4 adverse event(AE)[RR=2.15,95%CI(1.76,2.61),P<0.00001],severe adverse event[RR=1.78,95%CI(1.11,2.83),P=0.02],diarrhea[RR=3.29,95%CI(1.62,6.66),P=0.001],palmar-plantar erythrodysesthesia syndrome[RR=28.19,95%CI(12.25,64.88),P<0.00001],and hypertension[RR=6.50,95%CI(3.90,10.83),P<0.00001]in trial group were significantly higher than control group;there was no statistical significance in overall survival(OS)[HR=0.83,95%CI(0.67,1.02),P=0.07]or the incidence of fatigue[RR=1.25,95%CI(0.78,1.98),P=0.35]between the two groups.Subgroup analysis showed that PFS and ORR in patients with differentiated thyroid carcinoma(DTC)and medullary thyroid carcinoma(MTC)in the trial group were significantly higher than control group(P<0.05).There was no significant difference in OS of DTC and MTC patients in the trial group compared with the control group(P>0.05).CONCLUSIONS Cabozantinib can prolong PFS and increase ORR in patients with advanced thyroid cancer,but the incidence of AE is high.

关 键 词：卡博替尼 甲状腺癌 有效性 安全性 META分析 

分 类 号：R979.1[医药卫生—药品] R581.9[医药卫生—药学]