瑞戈非尼治疗晚期骨肉瘤与软组织肉瘤有效性和安全性Meta分析

Efficacy and Safety of Regofinib in the Treatment of Advanced Osteosarcoma and Soft Tissue Sarcoma:A Meta-Analysis

目的评价瑞戈非尼治疗晚期骨肉瘤与软组织肉瘤的有效性和安全性。方法采用计算机检索PubMed,Embase,The Cochrane Library,Web of Science及中国知网(CNKI)、万方(WanFang)、维普(VIP)、中国生物医学文献(CBM)数据库中自建库起至2023年11月19日关于瑞戈非尼治疗晚期骨肉瘤与软组织肉瘤的随机对照试验(RCT),采用Cochrane风险评估量表对纳入文献进行质量评价,采用RevMan 5.3软件进行Meta分析。结果共纳入8项RCT,涉及455例患者。Meta分析结果显示,试验组(予瑞戈非尼)治疗骨肉瘤与软组织肉瘤的疾病控制率[OR=4.18,95%CI(2.59,6.75),P<0.00001],3个月无进展生存期(PFS)率[OR=4.18,95%CI(2.69,6.48),P<0.00001],6个月PFS率[OR=3.99,95%CI(2.29,6.93),P<0.00001]均显著高于对照组(予安慰剂)。亚组分析结果显示,试验组治疗骨肉瘤的3个月PFS率[OR=6.22,95%CI(2.93,13.23),P<0.00001]和6个月PFS率[OR=3.62,95%CI(1.57,8.38),P=0.003]均显著高于对照组;试验组治疗非脂肪肉瘤的软组织肉瘤的3个月PFS率[OR=6.63,95%CI(3.17,13.86),P<0.00001]和6个月PFS率[OR=6.84,95%CI(2.57,18.19),P=0.0001]均显著高于对照组。试验组高血压、手足皮肤反应、腹泻、疲劳的发生率,以及≥3级高血压、手足皮肤反应和腹泻的发生率均显著高于对照组(P<0.05)。结论瑞戈非尼治疗非脂肪肉瘤的软组织肉瘤和骨肉瘤有效,不良反应发生风险基本可控。

Objective To evaluate the efficacy and safety of regofinib in the treatment of advanced osteosarcoma and soft tissue sarcoma.Methods Randomized controlled trials(RCTs)related to regofinib in the treatment of advanced osteosarcoma and soft tissue sarcoma in the PubMed,Embase,The Cochrane Library,Web of Science,CNKI,WanFang,VIP,and CBM databases from their inception to November 19,2023 were searched.The Cochrane risk assessment scale was used to evaluate the quality of the included literature,and RevMan 5.3 software was used for Meta-analysis.Results Eight RCTs were included,involving 455 patients.Meta-analysis results showed that the disease control rate[OR=4.18,95%CI(2.59,6.75),P<0.00001],3-month progression-free survival(PFS)rate[OR=4.18,95%CI(2.69,6.48),P<0.00001],and 6-month PFS rate[OR=3.99,95%CI(2.29,6.93),P<0.00001]in the experimental group(treated with regofinib)were significantly higher than those in the control group(treated with placebo).The sub-group analysis results showed that the 3-month PFS rate[OR=6.22,95%CI(2.93,13.23),P<0.00001]and 6-month PFS rate[OR=3.62,95%CI(1.57,8.38),P=0.003]of patients with osteosarcoma in the experimental group were significantly better than those in the control group;the 3-month PFS rate[OR=6.63,95%CI(3.17,13.86),P<0.00001]and 6-month PFS rate[OR=6.84,95%CI(2.57,18.19),P=0.0001]of patients with soft tissue sarcoma without liposarcoma in the experimental group were significantly higher than those in the control group.The incidence of hypertension,hand-foot skin reactions,and diarrhea,as well as the incidence of grade≥3 hypertension,hand-foot skin reactions,diarrhea,and fatigue in the experimental group were significantly higher than those in the control group(P<0.05).Conclusion Regofinib is effective in the treatment of patients with soft tissue sarcoma and osteosarcoma without liposarcoma,and the risk of adverse reactions is basically controllable.