地舒单抗用于绝经后激素受体阳性乳腺癌辅助治疗的系统评价

Denosumab Injection in the Adjuvant Treatment of Postmenopausal Women with Hormone Receptor-Positive Breast Cancer:A Systematic Review

目的系统评价地舒单抗用于绝经后激素受体阳性乳腺癌术后辅助治疗的安全性和有效性。方法采用计算机检索The Cochrane Library,PubMed,Embase,SinoMed及中国知网、维普、万方数据库,检索时限为自建库起至2020年10月,对符合纳入标准的随机对照试验(RCT)进行质量评价,采用RevMan5.3.5软件进行Meta分析。结果共纳入3项RCT 8 181例患者。Meta分析结果显示,地舒单抗用于绝经后激素受体阳性乳腺癌辅助治疗的5年无病生存率[RR=1.01,95%CI(0.98,1.04), P=0.48]和无骨转移生存率[HR=0.97,95%CI(0.82,1.14), P=0.70]与安慰剂相似,地舒单抗所致下颌骨坏死[RR=7.31,95%CI(0.34,158.30), P=0.20],关节痛[RR=1.00, 95%CI(0.94, 1.06), P=0.96],疲劳[RR=1.02, 95%CI(0.95, 1.09), P=0.67],便秘[RR=0.99, 95%CI(0.90, 1.08), P=0.79],肢体疼痛[RR=1.05,95%CI(0.95,1.17), P=0.31]发生率与安慰剂相似。结论地舒单抗用于绝经后激素受体阳性乳腺癌辅助治疗的安全性较好,但并未提高患者5年无病生存率和无骨转移生存率。

Objective To systematically evaluate the safety and efficacy of denosumab in the adjuvant treatment of postmenopausal women with hormone receptor-positive breast cancer.Methods The database of Cochrane Library,PubMed,Embase,SinoMed,CNKI,VIP,and WanFang were searched to collect the related randomized controlled trials(RCTs)from the inception to October 2020,and the quality of RCTs that met the inclusion criteria was evaluated.Meta-analysis was performed by the RevMan5.3.5 software.Results A total of three RCTs involving 8181 patients were included.The result of Meta-analysis showed that 5-year disease-free survival rate[RR=1.01,95%CI(0.98,1.04),P=0.48],and bone metastasis-free survival rate[HR=0.97,95%CI(0.82,1.14),P=0.70]were similar between adjuvant treatment with denosumab and placebo for postmenopausal women with hormone receptor-positive breast cancer.The incidence of osteonecrosis of the jaw[RR=7.31,95%CI(0.34,158.30),P=0.20],arthralgia[RR=1.00,95%CI(0.94,1.06),P=0.96],fatigue[RR=1.02,95%CI(0.95,1.09),P=0.67],constipation[RR=0.99,95%CI(0.90,1.08),P=0.79],pain in extremity[RR=1.05,95%CI(0.95,1.17),P=0.31]caused by denosumab and placebo was similar.Conclusion Denosumab is safe in the adjuvant treatment of postmenopausal women with hormone receptor-positive breast cancer,while it does not improve the5-year disease-free survival rate and bone metastasis-free survival rate.