表柔比星(法玛新)乳腺癌治疗课件

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；18:1133–442007St.Gallen早期乳腺癌治疗专家共识A.Goldhirschetal.Progressandpromise:highlightsoftheinternationalexpertconsensusontheprimarytherapyofearlybreastcancer2007.AnnalsofOncology2007；18:1133–442007St.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

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.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:CTX3.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.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)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.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-TermSurvivalinAdjuvantChemo