地舒单抗与唑来膦酸在实体肿瘤骨转移和多发性骨髓瘤患者中应用效果和安全性的Meta分析

Efficacy and safety of denosemab versus zoledronic acid in patients with solid tumors bone metastases and multiple myeloma:a meta-analysis

目的 系统评价地舒单抗与唑来膦酸在实体肿瘤骨转移和多发性骨髓瘤患者中的应用效果和安全性。方法 计算机检索PubMed、Embase、Cochrane Library、Web of Science、CNKI、WanFang Data和VIP数据库,搜集地舒单抗与唑来膦酸在实体肿瘤骨转移和多发性骨髓瘤患者中应用的随机对照试验(RCT),检索时限均为建库至2023年11月21日。由2名研究者独立筛选文献、提取资料并评价纳入研究的偏倚风险后,采用RevMan 5.3软件进行Meta分析。结果 共纳入5个RCT,包括8 957例患者。Meta分析结果显示,地舒单抗在推迟发生首次骨相关事件的时间[HR=0.85,95%CI(0.80,0.92),P<0.001]和发生首次及后续骨相关事件的时间[HR=0.87,95%CI(0.79,0.96),P=0.004]方面优于唑来膦酸。地舒单抗组肾脏毒性[RR=0.70,95%CI(0.58,0.85),P <0.001]、急性期反应[RR=0.46,95%CI(0.40,0.51),P <0.001]、贫血[HR=0.91,95%CI(0.85,0.98),P=0.008]和食欲下降/厌食[RR=0.89,95%CI(0.81,0.98),P=0.02]的发生率低于唑来膦酸组,但低钙血症的发生率更高[RR=1.72,95%CI(1.49,1.99),P <0.001]。两组在总生存期、疾病进展时间、不良事件发生率和严重不良事件发生率方面差异均无统计学意义(P> 0.05)。结论 当前证据表明,与唑来膦酸相比,地舒单抗能显著延迟实体瘤骨转移和多发性骨髓瘤引起骨相关事件的时间;在安全性方面,地舒单抗导致肾毒性、急性期反应、贫血和食欲下降/厌食的风险较低,但导致低钙血症的风险较高。

Objective To systematically review the efficacy and safety of denosemab and zoledronic acid in patients with solid tumors bone metastases and multiple myeloma.Methods Pubmed,Embase,Cochrane Library,Web of Science,CNKI,WanFang Data and VIP databases were electronically searched for randomized controlled trials(RCTs)related to denosemab and zoledronic acid in the solid tumors bone metastases and multiple myeloma from inception to November 21,2023.Two reviewers independently screened literature,extracted data and assessed the risk of bias of included studies,and Meta-analysis was performed by using RevMan 5.3 software.Results A total of 5 RCTs,involving 8957 patients were included.The results of Meta-analysis showed that denosumab was effective in delaying the time to first bone-related event(SRE)(HR=0.85,95%CI 0.80 to 0.92,P<0.001)and the time to first and subsequent SRE time(HR=0.87,95%CI 0.79 to 0.96,P=0.004)were superior to zoledronic acid.Denosumab had lower incidence of nephrotoxicity(RR=0.70,95%CI 0.58 to 0.85,P<0.001),acute phase response(RR=0.46,95%CI 0.40 to 0.51,P<0.001),anemia(RR=0.91,95%CI 0.85 to 0.98,P=0.008)and appetite decreased/anorexia(RR=0.89,95%CI 0.81 to 0.98,P=0.02),but the incidence of hypocalcemia was higher(RR=1.72,95%CI 1.49 to 1.99,P<0.001).There were no significant differences between denosumab and zoledronic acid in terms of overall survival,time to disease progression,incidence of adverse events and serious adverse events(P>0.05).Conclusion Current evidence shows that compared with zoledronic acid,denosemab can significantly delay SREs induced by solid tumors bone metastases and multiple myeloma.In terms of safety,the risk of denosemab-induced nephrotoxicity,acute phase reactions,anemia and decreased appetite/anorexia are lower,but the risk of denosemab-induced hypocalcemia is higher.