目的:系统评价PARPi治疗转移性去势抵抗性前列腺癌(mCRPC)的有效性及安全性,以期为临床决策供循证医学证据.方法:依据纳入和排除标准,网络检索2015年1月～2023年6月PubMed、Web of Science、Embace、Clinicial.gov中有关PARPi治疗mCRPC的随机对照试验文献,使用RevMan5.4 及Stata17.0软件对数据进行Meta分析.结果:纳入7篇随机对照试验文献,共1 888例患者.Meta分析结果表明,与非PARPi组比较,PARPi组(PARPi联合或不联合抗激素治疗)可提高mCRPC的放射学无进展生存期(HR=0.52,95%CI=0.34～0.78)和总生存期(HR=0.72,95%CI=0.60～0.86),差异均有统计学意义(P<0.05).在安全性方面,PARPi组1～2级骨痛、背痛、贫血、中性粒细胞减少、恶心、呕吐、腹泻、乏力不良反应发生率明显高于非PARPi组,差异均有统计学意义(P<0.05);≥3级上述不良反应中与非PARPi组比较,PARPi组中只有恶心和贫血不良反应发生率较高,差异均有统计学意义(P<0.05),而骨痛、背痛、中性粒细胞减少、呕吐、腹泻、乏力两组间比较差异均无统计学意义(P>0.05).结论:与非PARPi比较,PARPi联合或不联合抗激素治疗可提高mCRPC的放射学无进展生存期和总生存期,3级及以上不良反应发生率低,值得在临床上推广应用.
Abstract
Objective:To systematically evaluate the efficacy and safety of PARPi in the treatment of metastatic castration re-sistance prostate cancer mCRPC to provide evidence-based medical evidence for clinical decision making.Methods:According to the inclusion and exclusion criteria,PubMed,Web of Science,Embace,and Clinicial.gov were searched for randomized con-trolled trials of PARPi for treating mCRPC from January 2015 to June 2023.A Meta-analysis was performed using RevMan5.4 and Stata17.0 software.Results:Seven randomized controlled trials involving 1 888 patients were included.The results of the me-ta-analysis showed that compared with the non-PARPi group,the PARPi group(PARPi with or without anti-hormone therapy)exhibited significantly improved radiological progression-free survival(HR:0.52,95%CI:0.34-0.78)and overall survival(HR:0.72,95%CI:0.60-0.86)of mCRPC(P<0.05).In terms of safety,the incidence of grades 1-2 bone pain,back pain,anemia,neutropenia,nausea,vomiting,diarrhea,and fatigue was significantly higher in the PARPi group than in the non-PARPi group(P<0.05).Only the incidences of nausea and anemia were significantly higher in the PARPi group than in the non-PARPi group(P<0.05),with no significant difference in bone pain,back pain,neutropenia,vomiting,diarrhea,and fatigue between the two groups(P>0.05).Conclusion:Compared with non-PARPi,the treatment of mCRPC with PARPi with or without anti-hormone therapy can improve radiological progression-free survival and overall survival,with a low incidence of grade 3 and above adverse reactions,which is worthy of clinical application.
维普
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