乳腺癌五年或更长期的辅助内分泌治疗：一项已发表的随机试验的meta分析ppt课件

1、乳腺癌五年或更长期的辅助内分泌治疗：一项已发表的随机试验的meta分析Five or more years of adjuvant endocrine therapy in breast cancer: a meta-analysis of published randomised trialsFausto PetrelliBreast Cancer Res Treat 2013-6-281一、背景介绍在早期乳腺癌患者中（BC）2五年他莫西芬（TAM）辅助治疗死亡风险复发风险30%40%在各项随机试验中，辅助TAM治疗推荐应用：5年延滞效应：这种风险降低可以一直延续到开始使用内分泌治疗后的15

2、年，在10年后，死亡风险可降低1/3.一、背景介绍3ALAST 12000BC 5年VS10年TAM治疗中位随访13.6年：减少总生存及晚期BC发生子宫内膜癌发生风险(3.1 vs. 1.6 %),死亡风险增加0.2%。ATTOM10年TAM，减少BC复发风险(P = 0.003), BC 相关死亡风险 (P = 0.05) ，整体死亡风险 (P = 0.1), 第九年后的获益更大。MA 175年TAM 来曲唑/安慰剂，64个月的中位随访中，显著降低复发风险，但OS相近。考虑了揭盲后，安慰剂组中66%应用了来曲唑，提示来曲唑显著提高了DFS和OS 。二、研究方法1.数据来源4电子搜索Cochr

3、aneControlled Trials RegisterEMBASEISI Web of SciencePubMed参考文献/会议记录检索策略：(breast cancer OR breast carcinoma) and (tamoxifen OR letrozole OR exemestane OR anastrozole) and (extended OR duration OR longer OR continued OR 5 years OR 10 years OR prolonged OR continuing) and (randomised OR randomised)二、研

4、究方法2.研究选择/数据提取5入选标准提取数据早期乳腺癌患者RCT:比较5年及更久内分泌治疗开始2013-6-11研究由两名研究人员分别选择，出现分歧时有第三名研究人员评议。英文发表基本信息：杂志名、发表年份、作者名人口统计学：中位年龄、淋巴结水平、月经状态、原发肿瘤的激素水平研究信息：样本量、研究设计、研究终点治疗方案结果 （率或事件数）：OS, 无复发生存(RFS), 乳腺癌相关生存(BCSS), 非癌症相关死亡, 局部或远处的 RFS (LR-RFS/D-RFS)人类研究二、研究方法6主要终点：OS ( 随机至各种原因引起的死亡)，BCSS (随机至复发后乳腺癌相关死亡) ，RFS (随

5、机至除对侧乳腺外的复发)次要终点：非肿瘤相关死亡, LR-RFS (BC相关的局灶或区域复发时间) and D-RFS (BC相关的远处复发)数据汇总和统计学分析：统计比值比（OR ）和95CI。异质性小：固定效应模型/MantelHaenszel法；异质性大：DerSimonianLaird法（随机效应模型）。根据样本量计算权重。X2 及I2检验用于不同研究OR异质性的检测。根据方案（T与芳香酶抑制剂），ER状态，LN（N与N-），绝经状态，对于OS，BCSS和RFS进行了敏感性分析。双尾P值0.05被认为有统计学意义。偏倚： Beggs and Eggers 检测及漏斗图的是否对称性。分析

6、软件：Review Manager 5.1 (RevMan5.1);(哥本哈根：北欧Cochrane中心，Cochrane协作网，2008年)和综合Meta分析软件（版本2.2.064，2011年7月27日）。三、结果71、这8个试验都是期临床试验2、除了ABCSG6a外，其余都是经5年TAM后随机3、 ECOG 和 Scottish研究中，观察至死亡或复发4、 MA 17 和 NSABP B-33试验中，分别有66%和33%对照组患者在揭盲后接受了实验组的药物治疗N=291385年TAM：14540继续TAM：21554芳香化酶抑制剂：7584三、结果8三、结果9主要终点：1.OS三、结果1

7、0主要终点：2.BCSSBCSS在TAM组的结果更加明显三、结果11主要终点：3.RFS亚组分析N+OR:0.76，P0.0001绝经后妇女OR:0.8，P0.0001ER+三、结果12次要终点：非癌症相关死亡、LR-DFS、D-DFS非癌症相关死亡两组中相似局部复发风险36%，P=0.02远处复发风险13%，P=0.02三、结果13发表偏倚Beggs test P=0.25, Eggers test P=0.24对OS的OR无影响四、讨论1、14Click to edit title styleThemeGallery is a Design Digital Content & Conten

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