摘要
目的:系统性评价临床试验研究报道中FGFR1抑制剂在实体瘤治疗中的安全性和有效性.方法:检索PubMed、Embase、Cochrane Library、Clinical trials、维普、中国知网、万方数据库,筛选FGFR1抑制剂在实体瘤患者治疗中的临床试验报道,用CMA3.7软件进行Meta分析.结果:最终纳入12篇关于FGFR1抑制剂的临床试验研究报道,包括 BGJ398、lucitanib、pazopanib、ARQ 087、AZD4547、ASP5878、Infigratinib、rogaratinib 和dovitinib共9种FGFR1抑制剂,共计700例实体瘤患者,均为单臂研究.Meta分析结果显示FGFR1抑制剂应用后引起的所有级别的总的不良反应率为96.7％.常见的有:①血液系统改变:血小板减少(6.0％)、贫血(8.7％)、白细胞减少(3.6％);②非血液系统改变:腹泻(39.3％)、转氨酶升高(31.7％)、恶心(31.4％).严重的不良反应(AE)(≥3级)发生率为47.3％.常见的有:①血液系统改变:血小板减少(1.6％)、贫血(1.0％)、白细胞减少(0.9％);②非血液系统改变:高血压(14.0％)、转氨酶异常(9.1％)、乏力(4.6％).单药治疗后疾病完全缓解率(CR)为5.9％、部分缓解率(PR)为8.9％;疾病稳定(SD)39.7％;疾病进展(PD)的发生率45.5％,总体疾病控制率达到为54.5％.结论:FGFR1抑制剂使用后产生的副作用可耐受和调控.临床试验研究证实FGFR1抑制剂对部分实体瘤的治疗有一定疗效,期待进一步增加临床试验研究,通过改变给药剂量或/和考虑联合用药以提高其疗效.
Abstract
Objective:To systematically evaluate the safety and efficacy of FGFR1 inhibitors in treatment of solid tumors reported in clinical trials.Methods:PubMed,Embase,Cochrane Library,Clinical trials,VIP,CNKI and Wanfang databases were searched to screen clinical trial reports on FGFR1 inhibitors in the treatment of solid tumor patients.Meta-analysis was performed using CMA 3.7 software.Results:Twelve clinical trials involving 9 FGFR1 inhibitors in 700 patients with solid tumors in a single-arm study were finally included.There were 9 FGFR1 inhibitors,including BGJ398,lucitanib,pazopanib,ARQ 087,AZD4547,ASP5878,Infigratinib,rogaratinib and dovitinib.Meta-analysis showed that the total adverse events(AEs)rate of all grades of FGFR1 inhibitors was 96.7％.① Hematological adverse events(AEs):thrombocytopenia(6.0％),anemia(8.7％),leukopenia(3.6％);② Non-hematological adverse events(AEs):diarrhea(39.3％),elevated aminotransferase(31.7％),nausea(31.4％).The incidence of severe adverse events(AE)(grade ≥3)was 47.3％.① Hematological adverse events(AEs):thrombocytopenia(1.6％),anemia(1.0％),leukopenia(0.9％);② Non-hematological adverse events(AEs):hypertension(14.0％),abnormal transaminase(9.1％),fatigue(4.6％).After monotherapy of FGFR1 inhibitor,the rates of complete response(CR),partial response(PR),stable disease(SD),disease progression(PD)were 5.9％,8.9％,39.7％,45.5％.The overall disease control rate was 54.5％.Conclusion:The side effects of FGFR1 inhibitors were tolerable and manageable.Clinical trials had demonstrated positive efficacy of FGFR1 inhibitors in the treatment of some solid tumors,and further clinical trials are expected to improve the efficacy of FGFR1 inhibitors by changing dosing and/or drug combinations.
NETL
NSTL
维普
万方数据