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乳腺癌五年或更長期的輔助內(nèi)分泌治療:
一項已發(fā)表的隨機試驗的meta分析Fiveormoreyearsofadjuvantendocrinetherapyinbreastcancer:ameta-analysisofpublishedrandomisedtrials——FaustoPetrelli——BreastCancerResTreat2013-6-281乳腺癌五年或更長期的輔助內(nèi)分泌治療:
一項已發(fā)表的隨機試驗的一、背景介紹在早期乳腺癌患者中(BC)2五年他莫西芬(TAM)輔助治療死亡風險復發(fā)風險30%40%在各項隨機試驗中,輔助TAM治療推薦應用:5年延滯效應:這種風險降低可以一直延續(xù)到開始使用內(nèi)分泌治療后的15年,在10年后,死亡風險可降低1/3.一、背景介紹在早期乳腺癌患者中(BC)2五年他莫西芬(TAM一、背景介紹3ALAST12000BC5年VS10年TAM治療中位隨訪13.6年:減少總生存及晚期BC發(fā)生子宮內(nèi)膜癌發(fā)生風險(3.1vs.1.6%),死亡風險增加0.2%。ATTOM10年TAM,減少BC復發(fā)風險(P=0.003),BC相關死亡風險(P=0.05),整體死亡風險(P=0.1),第九年后的獲益更大。MA175年TAM來曲唑/安慰劑,64個月的中位隨訪中,顯著降低復發(fā)風險,但OS相近。考慮了揭盲后,安慰劑組中66%應用了來曲唑,提示來曲唑顯著提高了DFS和OS。一、背景介紹3ALAST12000BC5年VS二、研究方法1.數(shù)據(jù)來源4電子搜索CochraneControlledTrialsRegisterEMBASEISIWebofSciencePubMed參考文獻/會議記錄檢索策略:(breastcancerORbreastcarcinoma)and(tamoxifenORletrozoleORexemestaneORanastrozole)and(extendedORdurationORlongerORcontinuedOR‘5years’OR‘10years’ORprolongedORcontinuing)and(randomisedORrandomised)二、研究方法1.數(shù)據(jù)來源4電子搜索CochraneEMBAS二、研究方法2.研究選擇/數(shù)據(jù)提取5入選標準提取數(shù)據(jù)早期乳腺癌患者RCT:比較5年及更久內(nèi)分泌治療開始——2013-6-11研究由兩名研究人員分別選擇,出現(xiàn)分歧時有第三名研究人員評議。英文發(fā)表基本信息:雜志名、發(fā)表年份、作者名人口統(tǒng)計學:中位年齡、淋巴結(jié)水平、月經(jīng)狀態(tài)、原發(fā)腫瘤的激素水平研究信息:樣本量、研究設計、研究終點治療方案結(jié)果
(率或事件數(shù)):OS,無復發(fā)生存(RFS),乳腺癌相關生存(BCSS),非癌癥相關死亡,局部或遠處的RFS(LR-RFS/D-RFS)人類研究二、研究方法2.研究選擇/數(shù)據(jù)提取5入選標準提取數(shù)據(jù)早期乳腺二、研究方法6主要終點:OS(隨機至各種原因引起的死亡),BCSS(隨機至復發(fā)后乳腺癌相關死亡),RFS(隨機至除對側(cè)乳腺外的復發(fā))次要終點:非腫瘤相關死亡,LR-RFS(BC相關的局灶或區(qū)域復發(fā)時間)andD-RFS(BC相關的遠處復發(fā))數(shù)據(jù)匯總和統(tǒng)計學分析:統(tǒng)計比值比(OR)和95%CI。異質(zhì)性?。汗潭ㄐP?Mantel–Haenszel法;異質(zhì)性大:DerSimonian–Laird法(隨機效應模型)。根據(jù)樣本量計算權重。X2及I2檢驗用于不同研究OR異質(zhì)性的檢測。根據(jù)方案(T與芳香酶抑制劑),ER狀態(tài),LN(N與N-),絕經(jīng)狀態(tài),對于OS,BCSS和RFS進行了敏感性分析。雙尾P值<0.05被認為有統(tǒng)計學意義。偏倚:Begg’sandEgger’s檢測及漏斗圖的是否對稱性。分析軟件:ReviewManager5.1(RevMan5.1);(哥本哈根:北歐Cochrane中心,Cochrane協(xié)作網(wǎng),2008年)和綜合Meta分析軟件(版本2.2.064,2011年7月27日)。二、研究方法6主要終點:OS(隨機至各種原因引起的死亡)三、結(jié)果71、這8個試驗都是Ⅲ期臨床試驗2、除了ABCSG6a外,其余都是經(jīng)5年TAM后隨機3、ECOG和Scottish研究中,觀察至死亡或復發(fā)4、MA17和NSABPB-33試驗中,分別有66%和33%對照組患者在揭盲后接受了實驗組的藥物治療N=291385年TAM:14540繼續(xù)TAM:21554芳香化酶抑制劑:7584三、結(jié)果71、這8個試驗都是Ⅲ期臨床試驗N=291385年T三、結(jié)果8三、結(jié)果8三、結(jié)果9主要終點:1.OS三、結(jié)果9主要終點:1.OS三、結(jié)果10主要終點:2.BCSSBCSS在TAM組的結(jié)果更加明顯三、結(jié)果10主要終點:2.BCSSBCSS在TAM組的結(jié)果更三、結(jié)果11主要終點:3.RFS亞組分析N+OR:0.76,P<0.0001絕經(jīng)后婦女OR:0.8,P<0.0001ER+三、結(jié)果11主要終點:3.RFS亞組分析N+OR:0.76,三、結(jié)果12次要終點:非癌癥相關死亡、LR-DFS、D-DFS非癌癥相關死亡兩組中相似局部復發(fā)風險36%,P=0.02遠處復發(fā)風險13%,P=0.02三、結(jié)果12次要終點:非癌癥相關死亡、LR-DFS、D-DF三、結(jié)果13發(fā)表偏倚Begg’stestP=0.25,Egger’stestP=0.24對OS的OR無影響三、結(jié)果13發(fā)表偏倚Begg’stestP=0.25,四、討論1、14四、討論1、14ClicktoedittitlestyleThemeGalleryisaDesignDigitalContent&ContentsmalldevelopedbyGuildDesignInc.AddyourtextAddyourtextAddyourtextAddyourtextAddyourtextAddyourtext15ClicktoedittitlestyleThemeContentsClicktoaddtitleinhereClicktoaddtitleinhereClicktoaddtitleinhereClicktoaddtitleinhere4123ThemeGalleryisaDesignDigitalContent&ContentsmalldevelopedbyGuildDesignInc.16ContentsClicktoaddtitleinHotTip
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isaDesignDigitalContent&ContentsmalldevelopedbyGuildDesignInc.21ClicktoedittitlestyleConteClicktoedittitlestyleTextinhereTextinhereTextinhereThemeGalleryisaDesignDigitalContent&ContentsmalldevelopedbyGuildDesignInc.ClicktoaddText22ClicktoedittitlestyleTextClicktoedittitlestyleThemeGalleryisaDesignDigitalContent&ContentsmalldevelopedbyGuildDesignInc.Titleinhere2.Descriptionofthecompany’ssubcontentsThemeGalleryisaDesignDigitalContent&ContentsmalldevelopedbyGuildDesignInc.1.Descriptionofthecompany’ssubcontents23ClicktoedittitlestyleThemeClicktoedittitlestyleThemeGalleryisaDesignDigitalContent&ContentsmalldevelopedbyGuildDesignInc.TitleinhereTitleinhereTitleinhereTitleinhereABCD24ClicktoedittitlestyleTheme一、背景介紹DescriptionofthecontentsDescriptionofthecontentsDescriptionofthecontentsDescriptionofthecontentsDescriptionofthecontentsDescriptionofthecontentsContentTitleContentTitleContentTitle25ATLAS一、背景介紹DescriptionofthecontClicktoedittitlestyleDescriptionofthecontentsThemeGalleryisaDesignDigitalContent&ContentsmalldevelopedbyGuildDesignInc.ThemeGalleryisaDesignDigitalContent&ContentsmalldevelopedbyGuildDesignInc.ThemeGalleryisaDesignDigitalContent&ContentsmalldevelopedbyGuildDesignInc.TitleinhereTitleinhereTitleinhere26ClicktoedittitlestyleDescrClicktoedittitlestyleTextinhereTextinhereTextinhereTextinhereTextinhereTextinhereTextinhereTextinhereContentsContentsContentsContentsContentsThemeGalleryisaDesignDigitalContent&ContentsmalldevelopedbyGuildDesignInc.27ClicktoedittitlestyleTextClicktoedittitlestyleDescribeavisionofcompanyorstrategiccontents.Describeavisionofcompanyorstrategiccontents.Describeavisionofcompanyorstrategiccontents.Describeavisionofcompanyorstrategiccontents.Descriptionoftheproducts28ClicktoedittitlestyleDescrPleasewritedownofasloganforavisionofacompanyinshortly.Pleasewritedownofasloganforavisionofacompanyinshortly.Pleasewritedownofasloganforavisionofacompanyinshortly.Pleasewritedownofasloganforavisionofacompanyinshortly.Vision01Vision03Vision02Vision04CompanyLOGOClicktoedittitlestyle29PleasewritedownofPleasewrClicktoedittitlestyleTitleinhereThemeGalleryisaDesignDigitalContent&ContentsmalldevelopedbyGuildDesignInc.DescriptionofthecontentsDescriptionofthecontentsDescriptionofthecontentsDescriptionofthecontentsTitleinhereTitleinhereTitleinhere30ClicktoedittitlestyleTitleService01Service02Service03LOGOThemeGalleryisaDesignDigitalContent&ContentsmalldevelopedbyGuildDesignInc.Clicktoedittitlestyle31Service01Service02Service03ClicktoedittitlestyleTitleinhereAddTitleAddTitleAddTitleAddTitleDescriptionofthecontentsDescriptionofthecontentsDescriptionofthecontentsDescriptionofthecontentsTextinhereTextinhereTextinhereTextinhereDescriptionofthecontentsDescriptionofthecontentsDescriptionofthecontentsDescriptionofthecontents32ClicktoedittitlestyleTitleClicktoedittitlestyleThemeGalleryisaDesignDigitalContent&ContentsmalldevelopedbyGuildDesignInc.TitleTextinhereTextinhereTextinhereTextinhere33ClicktoedittitlestyleThemeClicktoedittitlestyleDescriptionofthecontentsThemeGalleryisaDesignDigitalContent&ContentsmalldevelopedbyGuildDesignInc.DescriptionofthecontentsThemeGalleryisaDesignDigitalContent&ContentsmalldevelopedbyGuildDesignInc.DescriptionofthecontentsThemeGalleryisaDesignDigitalContent&ContentsmalldevelopedbyGuildDesignInc.DescriptionofthecontentsThemeGalleryisaDesignDigitalContent&ContentsmalldevelopedbyGuildDesignInc.34ClicktoedittitlestyleDescClicktoedittitlestyleGrowthStartJump200820072006200520042003200220012000Descriptionofthecontents
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一項已發(fā)表的隨機試驗的meta分析Fiveormoreyearsofadjuvantendocrinetherapyinbreastcancer:ameta-analysisofpublishedrandomisedtrials——FaustoPetrelli——BreastCancerResTreat2013-6-2844乳腺癌五年或更長期的輔助內(nèi)分泌治療:
一項已發(fā)表的隨機試驗的一、背景介紹在早期乳腺癌患者中(BC)45五年他莫西芬(TAM)輔助治療死亡風險復發(fā)風險30%40%在各項隨機試驗中,輔助TAM治療推薦應用:5年延滯效應:這種風險降低可以一直延續(xù)到開始使用內(nèi)分泌治療后的15年,在10年后,死亡風險可降低1/3.一、背景介紹在早期乳腺癌患者中(BC)2五年他莫西芬(TAM一、背景介紹46ALAST12000BC5年VS10年TAM治療中位隨訪13.6年:減少總生存及晚期BC發(fā)生子宮內(nèi)膜癌發(fā)生風險(3.1vs.1.6%),死亡風險增加0.2%。ATTOM10年TAM,減少BC復發(fā)風險(P=0.003),BC相關死亡風險(P=0.05),整體死亡風險(P=0.1),第九年后的獲益更大。MA175年TAM來曲唑/安慰劑,64個月的中位隨訪中,顯著降低復發(fā)風險,但OS相近??紤]了揭盲后,安慰劑組中66%應用了來曲唑,提示來曲唑顯著提高了DFS和OS。一、背景介紹3ALAST12000BC5年VS二、研究方法1.數(shù)據(jù)來源47電子搜索CochraneControlledTrialsRegisterEMBASEISIWebofSciencePubMed參考文獻/會議記錄檢索策略:(breastcancerORbreastcarcinoma)and(tamoxifenORletrozoleORexemestaneORanastrozole)and(extendedORdurationORlongerORcontinuedOR‘5years’OR‘10years’ORprolongedORcontinuing)and(randomisedORrandomised)二、研究方法1.數(shù)據(jù)來源4電子搜索CochraneEMBAS二、研究方法2.研究選擇/數(shù)據(jù)提取48入選標準提取數(shù)據(jù)早期乳腺癌患者RCT:比較5年及更久內(nèi)分泌治療開始——2013-6-11研究由兩名研究人員分別選擇,出現(xiàn)分歧時有第三名研究人員評議。英文發(fā)表基本信息:雜志名、發(fā)表年份、作者名人口統(tǒng)計學:中位年齡、淋巴結(jié)水平、月經(jīng)狀態(tài)、原發(fā)腫瘤的激素水平研究信息:樣本量、研究設計、研究終點治療方案結(jié)果
(率或事件數(shù)):OS,無復發(fā)生存(RFS),乳腺癌相關生存(BCSS),非癌癥相關死亡,局部或遠處的RFS(LR-RFS/D-RFS)人類研究二、研究方法2.研究選擇/數(shù)據(jù)提取5入選標準提取數(shù)據(jù)早期乳腺二、研究方法49主要終點:OS(隨機至各種原因引起的死亡),BCSS(隨機至復發(fā)后乳腺癌相關死亡),RFS(隨機至除對側(cè)乳腺外的復發(fā))次要終點:非腫瘤相關死亡,LR-RFS(BC相關的局灶或區(qū)域復發(fā)時間)andD-RFS(BC相關的遠處復發(fā))數(shù)據(jù)匯總和統(tǒng)計學分析:統(tǒng)計比值比(OR)和95%CI。異質(zhì)性小:固定效應模型/Mantel–Haenszel法;異質(zhì)性大:DerSimonian–Laird法(隨機效應模型)。根據(jù)樣本量計算權重。X2及I2檢驗用于不同研究OR異質(zhì)性的檢測。根據(jù)方案(T與芳香酶抑制劑),ER狀態(tài),LN(N與N-),絕經(jīng)狀態(tài),對于OS,BCSS和RFS進行了敏感性分析。雙尾P值<0.05被認為有統(tǒng)計學意義。偏倚:Begg’sandEgger’s檢測及漏斗圖的是否對稱性。分析軟件:ReviewManager5.1(RevMan5.1);(哥本哈根:北歐Cochrane中心,Cochrane協(xié)作網(wǎng),2008年)和綜合Meta分析軟件(版本2.2.064,2011年7月27日)。二、研究方法6主要終點:OS(隨機至各種原因引起的死亡)三、結(jié)果501、這8個試驗都是Ⅲ期臨床試驗2、除了ABCSG6a外,其余都是經(jīng)5年TAM后隨機3、ECOG和Scottish研究中,觀察至死亡或復發(fā)4、MA17和NSABPB-33試驗中,分別有66%和33%對照組患者在揭盲后接受了實驗組的藥物治療N=291385年TAM:14540繼續(xù)TAM:21554芳香化酶抑制劑:7584三、結(jié)果71、這8個試驗都是Ⅲ期臨床試驗N=291385年T三、結(jié)果51三、結(jié)果8三、結(jié)果52主要終點:1.OS三、結(jié)果9主要終點:1.OS三、結(jié)果53主要終點:2.BCSSBCSS在TAM組的結(jié)果更加明顯三、結(jié)果10主要終點:2.BCSSBCSS在TAM組的結(jié)果更三、結(jié)果54主要終點:3.RFS亞組分析N+OR:0.76,P<0.0001絕經(jīng)后婦女OR:0.8,P<0.0001ER+三、結(jié)果11主要終點:3.RFS亞組分析N+OR:0.76,三、結(jié)果55次要終點:非癌癥相關死亡、LR-DFS、D-DFS非癌癥相關死亡兩組中相似局部復發(fā)風險36%,P=0.02遠處復發(fā)風險13%,P=0.02三、結(jié)果12次要終點:非癌癥相關死亡、LR-DFS、D-DF三、結(jié)果56發(fā)表偏倚Begg’stestP=0.25,Egger’stestP=0.24對OS的OR無影響三、結(jié)果13發(fā)表偏倚Begg’stestP=0.25,四、討論1、57四、討論1、14ClicktoedittitlestyleThemeGalleryisaDesignDigitalContent&ContentsmalldevelopedbyGuildDesignInc.AddyourtextAddyourtextAddyourtextAddyourtextAddyourtextAddyourtext58ClicktoedittitlestyleThemeContentsClicktoaddtitleinhereClicktoaddtitleinhereClicktoaddtitleinhereClicktoaddtitleinhere4123ThemeGalleryisaDesignDigitalContent&ContentsmalldevelopedbyGuildDesignInc.59ContentsClicktoaddtitleinHotTip
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