绝经后激素受体阳性乳腺癌患者应用雌激素调节剂与第三代芳香化酶抑制剂疗效及安全性的Meta分析  

Efficacy and safety of the hormone receptor modulator and the third generation of aromatase inhibitors for postmenopausal hormone receptor-positive breast cancer patients: a meta-analysis

作　　者：杨瑞杰[1] 王新帅[1] 冯莹莹[1] 冯笑山[1] 

机构地区：[1]河南科技大学临床医学院第一附属医院肿瘤科,河南洛阳471003

出　　处：《中国循证医学杂志》2017年第6期669-676,共8页Chinese Journal of Evidence-based Medicine

摘　　要：目的探究序贯使用他莫昔芬和第三代芳香化酶抑制剂与单独使用他莫昔芬或第三代芳香化酶抑制剂对绝经后激素受体阳性乳腺癌患者的有效性和安全性。方法计算机检索The Cochrane Library(2016年10期)、Pub Med、EMbase、CNKI、Wan Fang Data数据库,搜集他莫昔芬与芳香化酶抑制剂序贯治疗方案对比单药治疗方案治疗绝经后激素受体阳性乳腺癌的随机对照试验(RCT),检索时限均为从建库至2016年10月。由2位评价员独立筛选文献、提取资料并评价纳入研究的偏倚风险后,采用Rev Man 5.3软件进行Meta分析。结果共纳入9个RCT,包含22 005例患者。Meta分析结果显示:序贯治疗组的总生存期[HR=0.71,95%CI(0.52,0.98),P=0.04]和无复发生存期[HR=0.60,95%CI(0.46,0.79),P=0.000 3]明显优于他莫昔芬单药治疗组。序贯治疗组与芳香化酶抑制剂单药组在总生存期和无病生存期方面差异无统计学意义。在安全性方面,与他莫昔芬单药组相比,序贯治疗组降低了子宫内膜增生发生率[OR=0.22,95%CI(0.11,0.45),P<0.000 01]、死亡率[OR=0.74,95%CI(0.66,0.84),P<0.000 01]和远处转移率[OR=0.79,95%CI(0.68,0.91),P=0.001],但增加了骨折发生率[OR=1.31,95%CI(1.13,1.51),P=0.000 3]。结论序贯使用他莫昔芬与第三代芳香化酶抑制剂对比他莫西芬单药治疗绝经后激素受体阳性乳腺癌患者具有较好疗效和安全性,但序贯治疗方案对比芳香化酶抑制剂单药方案在生存获益上并无优势。Objective To investigate the efficacy and safety of using tamoxifen sequential with the third generation aromatase inhibitors versus the third generation aromatase inhibitors or tamoxifen alone for postmenopausal hormone receptor-positive breast cancer patients. Methods The Cochrane Library （Issue 10, 2016）, PubMed, EMbase, CNKI, and WanFang Data were searched to collect randomized controlled trials on using tamoxifen sequential with the third generation aromatase inhibitors versus the third generation aromatase inhibitors or tamoxifen alone for postmenopausal hormone receptor-positive breast cancer patients from inception to October, 2016. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies, then meta-analysis was performed by using RevMan 5.3 software. Results A total of 9 studies involving 22 005 patients were included. The results of meta-analysis showed that the sequential therapy group was superior to the tamoxifen monotherapy group on overall survival （HR=0.71, 95%CI 0.52 to 0.98, P=0.04） and recurrence-free survival （HR=0.60, 95%CI 0.46 to 0.79, P=0.000 3）. However, no significant difference was found in overall survival and disease free survival between the sequential therapy group and the aromatase inhibitors monotherapy group. As to adverse events, compared with the tamoxifen monotherapy group, the sequential therapy group could reduce the incidence of endometrial hyperplasia （OR=0.22, 95%CI 0.11 to 0.45, P〈0.000 01）, death （OR=0.74, 95%CI 0.66 to 0.84, P〈0.000 01） and metastasis （OR=0.79, 95%CI 0.68 to 0.91, P=0.001）; however, the incidence of bone fracture was higher in sequential therapy group compared with intamoxifen monotherapy group （OR=1.31, 95%CI 1.13 to 1.51, P=0.000 3）. Conclusion The sequential therapy using tamoxifen and the third generation of aromatase inhibitors is better than tamoxifen monotherapy for postmenopausal hormone receptor-positive breast cancer patients. However, there is no signifi

关 键 词：乳腺癌 芳香化酶抑制剂 他莫昔芬 生存期 META分析 系统评价 随机对照试验 

分 类 号：R737.9[医药卫生—肿瘤]