延长辅助内分泌治疗对比5年标准治疗对雌激素受体阳性早期乳腺癌患者预后影响的Meta分析

Extended adjuvant endocrine therapy vs five-year standard treatment for estrogen receptor-positive early breast cancer: a meta-analysis on patient prognosis

目的探讨延长辅助内分泌治疗5年以上对雌激素受体(ER)阳性早期乳腺癌患者预后的影响。方法检索Pubmed、Cochrane图书馆、Medline数据库、Embase数据库、中国期刊全文数据库(CNKI)及万方数据库,收集有关延长辅助内分泌治疗疗效比较的随机对照研究。按照纳入及排除标准,由2名研究人员独立进行筛选并提取相关数据,总生存率、无瘤生存率、乳腺癌特异性生存率以及复发率作为观察指标。采用Rev Man 5.3软件进行Meta分析。结果共纳入1996—2016年11篇随机对照研究,纳入患者29 000例。对数据进行统计分析显示:相比5年辅助内分泌治疗,5年以上的治疗并不能够显著改善ER阳性早期乳腺癌患者的总生存率(OR=1.02,95%CI:0.90~1.15,P=0.790),却能够改善无瘤生存率(OR=0.87,95%CI:0.75~0.99,P=0.040)、乳腺癌特异性生存率(OR=0.87,95%CI:0.79~0.96,P=0.004)以及降低复发率(OR=0.76,95%CI:0.64~0.90,P=0.001)。坚持5年以上辅助内分泌治疗能够使ER阳性早期乳腺癌患者受益。结论对于ER阳性早期乳腺癌患者,建议延长辅助内分泌治疗。

Objective To evaluate the efficacy of extended adjuvant endocrine therapy for over 5 years in early breast cancer patients with estrogen receptor positive.Methods The related clinical controlled trials in literature on the efficacy comparison between standard endocrine therapy and extended adjuvant endocrine therapy were retrieved from the databases of Pubmed,Cochrane,Medline,Embase,China National Knowledge Infrastructure(CNKI)and WanFang.The screening was independently performed by two researchers according to the inclusion and exclusion criteria.The overall survival,disease-free survival,breast cancer-specific survival and recurrence rate were analyzed as indicators.The data were extracted and a meta-analysis was performed by the RevMan 5.3 software.Results The 11 randomized controlled studies involving 29 000 patients from 1996 to 2016 were included for the meta-analysis.The extended adjuvant endocrine therapy for more than 5 years did not significantly improve the overall survival in the early breast cancer patients with ER positive(OR=1.02,95%CI:0.90-1.15,P=0.790),but it improved the disease-free survival(OR=0.87,95%CI:0.75-0.99,P=0.040)and breast cancer-specific survival(OR=0.87,95%CI:0.79-0.96,P=0.004)and reduced the recurrence rate(OR=0.76,95%CI:0.64-0.90,P=0.001).The early breast cancer patients with estrogen receptor positive could benefit from extended adjuvant endocrine therapy for more than 5 years.Conclusion For ER-positive patients with early-stage breast cancer,it is recommended to extend the adjuvant endocrine therapy for over 5 years.