Objective This study aimed to analyze the adverse effects(AEs)of sacituzumab govitecan(SG)through multiple sources of data to provide a reference for clinical safety management.Methods Clinical trials of SG with avail...Objective This study aimed to analyze the adverse effects(AEs)of sacituzumab govitecan(SG)through multiple sources of data to provide a reference for clinical safety management.Methods Clinical trials of SG with available safety data were retrieved and included in the pooled analysis.The adverse drug reaction(ADR)signals of SG were collected from the FDA Adverse Event Reporting System(FAERS)database.Drug interactions with SG in the DDInter database were summarized.Results A total of 6 clinical trials involving 1737 patients were included in the pooled analysis,and the most common AEs of≥grade 3 were neutropenia(46%),leukopenia(13%),and anemia(8%).In the pharmacovigilance study,1024 AE reports were extracted,and the most common toxicities of SG were hematologic and gastrointestinal.AEs not included in the drug instructions also presented high signals,such as meningitis,colitis and lymphedema.A total of 40 drugs identified could induce drug–drug interactions when they were concomitantly administered with SG.Conclusions This study provides the most comprehensive profile of SG toxicity on the basis of data from clinical trials and the FRAES and DDInter databases.Attention should be given not only to common ADRs but also to ADRs not reported in drug instructions,and potential drugs that can induce drug–drug interactions.展开更多
目的探讨美国食品和药品管理局不良事件报告系统(Food and Drug Administration adverse event reporting system,FAERS)数据库中戈沙妥珠单抗的药物不良事件(adverse drug event,ADE)信号进行挖掘分析。方法选择美国FAERS数据库中2020...目的探讨美国食品和药品管理局不良事件报告系统(Food and Drug Administration adverse event reporting system,FAERS)数据库中戈沙妥珠单抗的药物不良事件(adverse drug event,ADE)信号进行挖掘分析。方法选择美国FAERS数据库中2020年第2季度至2024年第1季度的戈沙妥珠单抗相关ADE报告。运用比值失衡法中的报告比值比法联合贝叶斯可信区间递进神经网络法(bayesian confidence propagation neural network,BCPNN)进行数据挖掘及分析。结果筛选后,共获得3085例ADE报告。其中女性患者占比较多(86.09%),年龄人群以45~64岁(25.35%)为主。上报国家以美国(34.20%)为主;转归结果以死亡(26.65%)和住院(28.75%)为主。有145个与ADE相关的阳性信号涉及26个系统器官分类。ADE信号发生频次较高的与说明书基本一致。说明书中未提及严重不良反应有出血性腹泻、麻痹性肠梗阻、大肠穿孔,发热性骨髓再生障碍以及骨髓功能衰竭等。结论医生临床使用戈沙妥珠单抗时应做好患者用药评估,治疗期间应警惕新的不良反应的发生,当发现异常时应及时干预。展开更多
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...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。展开更多
基金supported by grants from the National Natural Science Foundation of China(82200212)and(81902934).
文摘Objective This study aimed to analyze the adverse effects(AEs)of sacituzumab govitecan(SG)through multiple sources of data to provide a reference for clinical safety management.Methods Clinical trials of SG with available safety data were retrieved and included in the pooled analysis.The adverse drug reaction(ADR)signals of SG were collected from the FDA Adverse Event Reporting System(FAERS)database.Drug interactions with SG in the DDInter database were summarized.Results A total of 6 clinical trials involving 1737 patients were included in the pooled analysis,and the most common AEs of≥grade 3 were neutropenia(46%),leukopenia(13%),and anemia(8%).In the pharmacovigilance study,1024 AE reports were extracted,and the most common toxicities of SG were hematologic and gastrointestinal.AEs not included in the drug instructions also presented high signals,such as meningitis,colitis and lymphedema.A total of 40 drugs identified could induce drug–drug interactions when they were concomitantly administered with SG.Conclusions This study provides the most comprehensive profile of SG toxicity on the basis of data from clinical trials and the FRAES and DDInter databases.Attention should be given not only to common ADRs but also to ADRs not reported in drug instructions,and potential drugs that can induce drug–drug interactions.
文摘目的探讨美国食品和药品管理局不良事件报告系统(Food and Drug Administration adverse event reporting system,FAERS)数据库中戈沙妥珠单抗的药物不良事件(adverse drug event,ADE)信号进行挖掘分析。方法选择美国FAERS数据库中2020年第2季度至2024年第1季度的戈沙妥珠单抗相关ADE报告。运用比值失衡法中的报告比值比法联合贝叶斯可信区间递进神经网络法(bayesian confidence propagation neural network,BCPNN)进行数据挖掘及分析。结果筛选后,共获得3085例ADE报告。其中女性患者占比较多(86.09%),年龄人群以45~64岁(25.35%)为主。上报国家以美国(34.20%)为主;转归结果以死亡(26.65%)和住院(28.75%)为主。有145个与ADE相关的阳性信号涉及26个系统器官分类。ADE信号发生频次较高的与说明书基本一致。说明书中未提及严重不良反应有出血性腹泻、麻痹性肠梗阻、大肠穿孔,发热性骨髓再生障碍以及骨髓功能衰竭等。结论医生临床使用戈沙妥珠单抗时应做好患者用药评估,治疗期间应警惕新的不良反应的发生,当发现异常时应及时干预。
