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分析课件

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Fiveormoreyearsofadjuvantendocrinetherapyinbreastcancer:ameta-analysisofpublishedrandomisedtrials——FaustoPetrelli——BreastCancerResTreat2013-6-281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年，在10年后，死亡风险可降低1/3.一、背景介绍在早期乳腺癌患者中（BC）2五年他莫西芬（TAM一、背景介绍3ALAST12000BC5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(3.1vs.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。MA175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。一、背景介绍3ALAST12000BC5年VS二、研究方法1.数据来源4电子搜索CochraneControlledTrialsRegisterEMBASEISIWebofSciencePubMed参考文献/会议记录检索策略：(breastcancerORbreastcarcinoma)and(tamoxifenORletrozoleORexemestaneORanastrozole)and(extendedORdurationORlongerORcontinuedOR‘5years’OR‘10years’ORprolongedORcontinuing)and(randomisedORrandomised)二、研究方法1.数据来源4电子搜索CochraneEMBAS二、研究方法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2.研究选择/数据提取5入选标准提取数据早期乳腺二、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)andD-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95％CI。异质性小：固定效应模型/Mantel–Haenszel法；异质性大：DerSimonian–Laird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：Begg’sandEgger’s检测及漏斗图的是否对称性。分析软件：ReviewManager5.1(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）。二、研究方法6主要终点：OS(随机至各种原因引起的死亡)三、结果71、这8个试验都是Ⅲ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、MA17和NSABPB-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71、这8个试验都是Ⅲ期临床试验N=291385年T三、结果8三、结果8三、结果9主要终点：1.OS三、结果9主要终点：1.OS三、结果10主要终点：2.BCSSBCSS在TAM组的结果更加明显三、结果10主要终点：2.BCSSBCSS在TAM组的结果更三、结果11主要终点：3.RFS亚组分析N+OR:0.76，P<0.0001绝经后妇女OR:0.8，P<0.0001ER+三、结果11主要终点：3.RFS亚组分析N+OR:0.76，三、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12次要终点：非癌症相关死亡、LR-DFS、D-DF三、结果13发表偏倚Begg’stestP=0.25,Egger’stestP=0.24对OS的OR无影响三、结果13发表偏倚Begg’stestP=0.25,四、讨论1、14四、讨论1、14ClicktoedittitlestyleThemeGalleryisaDesignDigitalContent&ContentsmalldevelopedbyGuildDesignInc.AddyourtextAddyourtextAddyourtextAddyourtextAddyourtextAddyourtext15ClicktoedittitlestyleThemeContentsClicktoaddtitleinhereClicktoaddtitleinhereClicktoaddtitleinhereClicktoaddtitleinhere4123ThemeGalleryisaDesignDigitalContent&ContentsmalldevelopedbyGuildDesignInc.16ContentsClicktoaddtitleinHotTip

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一项已发表的随机试验的meta分析Fiveormoreyearsofadjuvantendocrinetherapyinbreastcancer:ameta-analysisofpublishedrandomisedtrials——FaustoPetrelli——BreastCancerResTreat2013-6-2844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一、背景介绍在早期乳腺癌患者中（BC）45五年他莫西芬（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年，在10年后，死亡风险可降低1/3.一、背景介绍在早期乳腺癌患者中（BC）2五年他莫西芬（TAM一、背景介绍46ALAST12000BC5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(3.1vs.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。MA175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。一、背景介绍3ALAST12000BC5年VS二、研究方法1.数据来源47电子搜索CochraneControlledTrialsRegisterEMBASEISIWebofSciencePubMed参考文献/会议记录检索策略：(breastcancerORbreastcarcinoma)and(tamoxifenORletrozoleORexemestaneORanastrozole)and(extendedORdurationORlongerORcontinuedOR‘5years’OR‘10years’ORprolongedORcontinuing)and(randomisedORrandomised)二、研究方法1.数据来源4电子搜索CochraneEMBAS二、研究方法2.研究选择/数据提取48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2.研究选择/数据提取5入选标准提取数据早期乳腺二、研究方法49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)andD-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95％CI。异质性小：固定效应模型/Mantel–Haenszel法；异质性大：DerSimonian–Laird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：Begg’sandEgger’s检测及漏斗图的是否对称性。分析软件：ReviewManager5.1(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）。二、研究方法6主要终点：OS(随机至各种原因引起的死亡)三、结果501、这8个试验都是Ⅲ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、MA17和NSABPB-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71、这8个试验都是Ⅲ期临床试验N=291385年T三、结果51三、结果8三、结果52主要终点：1.OS三、结果9主要终点：1.OS三、结果53主要终点：2.BCSSBCSS在TAM组的结果更加明显三、结果10主要终点：2.BCSSBCSS在TAM组的结果更三、结果54主要终点：3.RFS亚组分析N+OR:0.76，P<0.0001绝经后妇女OR:0.8，P<0.0001ER+三、结果11主要终点：3.RFS亚组分析N+OR:0.76，三、结果55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12次要终点：非癌症相关死亡、LR-DFS、D-DF三、结果56发表偏倚Begg’stestP=0.25,Egger’stestP=0.24对OS的OR无影响三、结果13发表偏倚Begg’stestP=0.25,四、讨论1、57四、讨论1、14ClicktoedittitlestyleThemeGalleryisaDesignDigitalContent&ContentsmalldevelopedbyGuildDesignInc.AddyourtextAddyourtextAddyourtextAddyourtextAddyourtextAddyourtext58ClicktoedittitlestyleThemeContentsClicktoaddtitleinhereClicktoaddtitleinhereClicktoaddtitleinhereClicktoaddtitleinhere4123ThemeGalleryisaDesignDigitalContent&ContentsmalldevelopedbyGuildDesignInc.59ContentsClicktoaddtitleinHotTip

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