表柔比星法玛新乳腺癌治疗

精选课件目录含法玛新®FEC/CEF方案是NCCN指南和StGallen共识推荐的早期乳腺癌辅助治疗的基础方案1，2FEC100相比FEC50显著提高10年无病生存率和总生存率3FEC100的迟发性心脏毒性和继发性恶性肿瘤发生率与FEC50无显著差异31.NCCNClinicalPracticeGuidelinesinOncology™；BreastCancer；V.2.20073.JacquesBonneterre,HenriRoché,etal.EpirubicinIncreasesLong-TermSurvivalinAdjuvantChemotherapyofPatientsWithPoor-Prognosis,Node-Positive,EarlyBreastCancer:10-YearFollow-UpResultsoftheFrenchAdjuvantStudyGroup05RandomizedTrial.JClinOncol.2005Apr20;23(12):2686-93.2.A.Goldhirschetal.Progressandpromise:highlightsoftheinternationalexpertconsensusontheprimarytherapyofearlybreastcancer2007.AnnalsofOncology2007；18:1133–44精选课件精选课件精选课件精选课件2007St.Gallen早期乳腺癌治疗专家共识A.Goldhirschetal.Progressandpromise:highlightsoftheinternationalexpertconsensusontheprimarytherapyofearlybreastcancer2007.AnnalsofOncology2007；18:1133–44精选课件2007St.Gallen共识重点：重申对早期乳腺癌患者根据内分泌治疗敏感性的评价来确定合适的系统治疗方案的重要性。A.Goldhirschetal.Progressandpromise:highlightsoftheinternationalexpertconsensusontheprimarytherapyofearlybreastcancer2007.AnnalsofOncology2007；18:1133–44精选课件内分泌治疗高度敏感内分泌治疗敏感性不确定内分泌治疗不敏感2007St.Gallen共识

对内分泌治疗的敏感性分类A.Goldhirschetal.Progressandpromise:highlightsoftheinternationalexpertconsensusontheprimarytherapyofearlybreastcancer2007.AnnalsofOncology2007；18:1133–44精选课件低度危险：淋巴结阴性并具备所有以下特征pT≤2cm病理分级为1级ER和/或PgR表达未侵犯肿瘤周边血管无HER2/neu基因过表达或扩增年龄≥35岁

2007St.Gallen共识：

早期乳腺癌危险度分级A.Goldhirschetal.Progressandpromise:highlightsoftheinternationalexpertconsensusontheprimarytherapyofearlybreastcancer2007.AnnalsofOncology2007；18:1133–44精选课件高度危险:淋巴结阳性(1－3个淋巴结受累)，ER和PgR缺失，或HER2/neu基因过表达或扩增淋巴结阳性（4个或4个以上淋巴结受累）2007St.Gallen共识:

乳腺癌危险度分级A.Goldhirschetal.Progressandpromise:highlightsoftheinternationalexpertconsensusontheprimarytherapyofearlybreastcancer2007.AnnalsofOncology2007；18:1133–44精选课件中度危险:淋巴结阴性并至少具备以下特征中的一项pT＞2cm病理分级为2－3级ER和PgR缺失有肿瘤周边血管侵犯HER2/neu基因过表达或扩增年龄＜35岁淋巴结阳性(1-3个淋巴结受累)，ER和PgR表达，且无HER2/neu基因过表达或扩增

2007St.Gallen共识：

早期乳腺癌危险度分级A.Goldhirschetal.Progressandpromise:highlightsoftheinternationalexpertconsensusontheprimarytherapyofearlybreastcancer2007.AnnalsofOncology2007；18:1133–44精选课件内分泌治疗高度敏感内分泌治疗敏感性不确定内分泌治疗不敏感HER2阴性ET（根据患者危险度分级考虑加用化疗）ET（根据患者危险度分级考虑加用化疗）化疗HER2阳性ET＋曲妥珠单抗＋化疗ET＋曲妥珠单抗＋化疗曲妥珠单抗＋化疗ET:内分泌治疗2007St.Gallen共识早期乳腺癌治疗推荐:

化疗仍然是基础治疗A.Goldhirschetal.Progressandpromise:highlightsoftheinternationalexpertconsensusontheprimarytherapyofearlybreastcancer2007.AnnalsofOncology2007；18:1133–44精选课件2007StGallen早期乳腺癌治疗：

化疗大部分专家支持对于所有的患者（除禁忌症）都可以使用含蒽环类的化疗方案联合环磷酰胺、5－氟尿嘧啶和蒽环类抗生素治疗方案，如FEC/CEF等得到广泛的认同和支持“……MostPanelistssupportedtheuseofanthracyclinesforallpatientsandanevengreatermajoritysupportedanthracyclineuseforpatientswithHER2-positivedisease……Combinationsofcyclophosphamide,5-fluorouracilandananthracycline(variouslyabbreviatedasCAF,CEF,FEC,FAC[93–96]),commandedrelativelywidesupport,asdidthesequenceofanthracyclineandcyclophosphamidefollowedbypaclitaxelordocetaxel……”A.Goldhirschetal.Progressandpromise:highlightsoftheinternationalexpertconsensusontheprimarytherapyofearlybreastcancer2007.AnnalsofOncology2007；18:1133–44精选课件

法玛新®用于辅助治疗提高淋巴结阳性，预后差的早期乳腺癌患者的长期生存（FASG-05III期、多中心随机研究10年随访结果）BonneterreJ,RochéH,KerbratP,etal.JClinoncol.2005Apr20;23(12):2686-93.精选课件F 500mg/m2IVE50mg/m2IV 每3周x6疗程*C500mg/m2IV

F500mg/m2IV

E100mg/m2IV 每3周x6疗程*

C500mg/m2IV试验设计*禁止预防性使用集落刺激因子和抗生素研究人群

(n=565)绝经前/后的妇女患者早期乳腺癌术后腋窝淋巴结阳性随机化3.JacquesBonneterre,HenriRoché,etal.EpirubicinIncreasesLong-TermSurvivalinAdjuvantChemotherapyofPatientsWithPoor-Prognosis,Node-Positive,EarlyBreastCancer:10-YearFollow-UpResultsoftheFrenchAdjuvantStudyGroup05RandomizedTrial.JClinOncol.2005Apr20;23(12):2686-93.F:5-FUE:EPIC:CTX精选课件3.JacquesBonneterre,HenriRoché,etal.EpirubicinIncreasesLong-TermSurvivalinAdjuvantChemotherapyofPatientsWithPoor-Prognosis,Node-Positive,EarlyBreastCancer:10-YearFollow-UpResultsoftheFrenchAdjuvantStudyGroup05RandomizedTrial.JClinOncol.2005Apr20;23(12):2686-93.两组患者特征无统计学差异精选课件两组治疗情况相似 FEC100 FEC50 (n=268) (n=278)完成6个疗程治疗患者的百分比94%

95.7%3.JacquesBonneterre,HenriRoché,etal.EpirubicinIncreasesLong-TermSurvivalinAdjuvantChemotherapyofPatientsWithPoor-Prognosis,Node-Positive,EarlyBreastCancer:10-YearFollow-UpResultsoftheFrenchAdjuvantStudyGroup05RandomizedTrial.JClinOncol.2005Apr20;23(12):2686-93.精选课件结果：FEC100相比FEC50

显著提高10年无病生存率3.JacquesBonneterre,HenriRoché,etal.EpirubicinIncreasesLong-TermSurvivalinAdjuvantChemotherapyofPatientsWithPoor-Prognosis,Node-Positive,EarlyBreastCancer:10-YearFollow-UpResultsoftheFrenchAdjuvantStudyGroup05RandomizedTrial.JClinOncol.2005Apr20;23(12):2686-93.随机后时间（月）0.51.000.80.924487296120144168无病生存率P=0.03650.7%45.3%FEC100（n=266)FEC50（n=271)精选课件结果：FEC100相比FEC50

显著提高10年总生存率3.JacquesBonneterre,HenriRoché,etal.EpirubicinIncreasesLong-TermSurvivalinAdjuvantChemotherapyofPatientsWithPoor-Prognosis,Node-Positive,EarlyBreastCancer:10-YearFollow-UpResultsoftheFrenchAdjuvantStudyGroup05RandomizedTrial.JClinOncol.2005Apr20;23(12):2686-00.80.924487296120144168随机后时间（月）总生存率P=0.03854.8%50.0%FEC100（n=266)FEC50（n=271)精选课件FEC100的迟发性心脏毒性和继发性恶性肿瘤的发生与FEC50无显著差异安全性FEC50(n=271)No.(%)FEC100(n=266)No.(%)P

迟发性心脏毒性4(1.5%)3(1.1%)NS继发性恶性肿瘤27(10.0%)22(8.3%)NS3.JacquesBonneterre,HenriRoché,etal.EpirubicinIncreasesLong-TermSurvivalinAdjuvantChemotherapyofPatientsWithPoor-Prognosis,Node-Positive,EarlyBreastCancer:10-YearFollow-UpResultsoftheFrenchAdjuvantStudyGroup05RandomizedTrial.JClinOncol.2005Apr20;23(12):2686-93.精选课件结论FEC100相比FEC50显著提高10年无病生存率和总生存率FEC100的迟发性心脏毒性和继发性恶性肿瘤的发生与FEC50无显著差异3.JacquesBonneterre,HenriRoché,etal.EpirubicinIncreasesLong-TermSurvivalinAdjuvantChemotherapyofPatientsWithPoor-Prognosis,Node-Positive,EarlyBreastCancer:10-YearFollow-UpResultsoftheFrenchAdjuvantStudyGroup05RandomizedTrial.JClinOncol.2005Apr20;23(12):2686-93.精选课件总结含法玛新®FEC/CE