氟维司群500mg治疗晚期乳腺癌有效性和安全性Meta分析

Fulvestrant 500mg in the treatment of advanced breast cancer:A systematic review and meta-analysis of randomized controlled trials

目的氟维司群是新型雌激素受体拮抗剂。为进一步明确氟维司群超说明书剂量给药方案的可行性,本研究通过Meta分析评价高剂量氟维司群治疗晚期乳腺癌的有效性和安全性。方法计算机检索PubMed、EMbase、CNKI、CBM、VIP及WanFang等数据库至2017-03-30,筛选500mg氟维司群治疗晚期乳腺癌的随机对照试验。结局指标包括临床获益率(clinical benefit rate,CBR)、客观缓解率(objective response rate,ORR)和不良事件(adverse events,AEs)。试验结果应用RevMan 5.3进行分析。结果 6项随机对照试验纳入Meta分析,试验组898例,对照组921例。Meta分析结果显示,CBR风险比(risk ratio,RR)=1.10,95%CI:1.01~1.19,P=0.02,差异有统计学意义;ORR的RR=1.02,95%CI:0.85~1.23,P=0.81;AEs的RR=1.00,95%CI:0.90~1.10,P=0.97;背痛的比值比(odds ratio,OR)=1.50,95%CI:0.87~2.56,P=0.14;恶心的OR=0.90,95%CI:0.56~1.44,P=0.66;疲乏的OR=1.38,95%CI:0.86~2.21,P=0.18;差异均无统计学意义。结论 500mg氟维司群临床获益率优于对照组,而不增加不良反应发生率。

OBJECTIVE Fulvestrant is a new type of estrogen receptor antagonist. To clarify the feasibility of the off-label drug use of FUL 500 mg, this study aimed to systematically evaluate the efficacy and safety of FUL 500 mg treatment for advanced breast cancer patients by meta analysis. METHODS PubMed, EMbase, CNKI, CBM, VIP, and WanFang databases were searched up to April 30, 2017 for relevant publications. Two reviewers selected the studies and extracted information independently. The outcome indicators include clinical benefit rate, objective response rate and ad verse events. Data extraction form eligible studies was pooled and met^analyzed using RevMan 5. 3 software. RESULTS Six case-control studies were included. Totally 898 patients in the exposed group and 921 patients in the control group were included. The pooled results showed that clinical benefit rate（CBR） RR= 1. 10, 95% CI：1. 01- 1. 19, P=0.02. There was statistically significant. Objective responserate（ORR） RR=1.02, 95%CI：0.85-1.23, P=0.81; Adverse events（AEs） RR=1. 00, 95%CI：0.90-1.10, P=0.97; Back pain OR=I. 50, 95%CI：0.87-2.56, P=0.14; Nausea OR=0.90, 95%CI：0. 56-1. 44, P=0.66; Fatigue OR=1.38, 95%CI：0. 86=2. 21, P=0. 18; There was no statistically significant respectively . CONCLUSION FUL500 mg used in exposed group is better than that in control group in terms of clinic benefit rate, the rate of adverse events is not increased correspondingly.