XELOX直肠癌患者辅助化疗的金标准ppt课件

Click to edit Master title style,Click to edit Master text styles,Second level,Third level,Fourth level,Fifth level,1,*,Click to edit Master title style,Click to edit Master text styles,Second level,Third level,Fourth level,Fifth level,XELOX,结直肠癌患者辅助化疗的金标准,XELOX结直肠癌患者辅助化疗的金标准,早期临床研究证实：,5-Fu,单药辅助化疗可显著延长结直肠癌患者的总生存期和复发时间,1,1,Sargent DJ,et al.A pooled analysis of adjuvant chemotherapy for resected colon cancer in elderly patients.N Engl J Med.2019 Oct 11;345(15):1091-7,2,NCCN Clinical Practice Guideline in Oncology.Colon Cancer.V.1.2019,p,0.001,p,0.001,期,、,期,结直肠癌患者,使用氟尿嘧啶为基础的辅助化疗能让患者进一步获益,NCCN,指南,2,推荐,II,期高危，,III,期结直肠癌患者术后使用联合方案辅助治疗,II,期无高危因素患者推荐使用氟尿嘧啶单药方案辅助治疗,早期临床研究证实：5-Fu单药辅助化疗可显著延长结直肠癌患者,卡培他滨单药辅助化疗优于,5-Fu/Lv,方案,Seidman AD,Aapro M.Introduction J.The Oncologist,2019,7(suppl 6):1-3.,Twelves C,Scheithauer W,McKendrick J,et al.Capecitabine versus 5-FU/LV in stage colon cancer:Updated 5-year efficacy data from X-ACT trial and preliminary analysis of relationship between hand-foot syndrome(HFS)and efficacy J.American Society of Clinical Oncology Gastrointestinal Cancers Symposium,2019,19(Suppl.6):A274,X-ACT,研究结果：希罗达,组的,DFS,显示出优势趋势,卡培他滨组显著减少,3/4,级,血液学毒性,卡培他滨单药辅助化疗优于5-Fu/Lv方案Seidman A,MOSAIC,(2009,年发表,),FOLFOX,5-FU/LV,(deGramont),NSABP C-07,(2019,年发表,),FLOX,5-FU/LV,(Roswell-Park),试验,对照组,新标准,X-ACT,(2019,年发表,),卡培他滨,5-FU/LV,(Mayo),5,年,DFS,提高,5.9%,4,年,DFS,提高,5.2%,5,年,DFS,提高,4.1%,XELOX,？,临床数据证明氟尿嘧啶与奥沙利铂联合方案优于单药方案,MOSAICFOLFOX5-FU/LV(deGramont),辅助化疗金标准的定义,辅助化疗金标准的定义,未接受过化,放疗治疗的,III,期结肠癌患者,n=1886,入组时间,2019-2019,年,快速静推,5-FU/LV,Mayo,CLINIC,或者,Roswell PARK,癌症研究所,XELOX,希罗达,1000mg/m,2,每日两次,d1,15,奥沙利铂,130mg/m,2,d1,每,3,周为一周期,q3w,主要终点,:,具有无病生存期（,DFS,）优势,n=944,n=942,随,机,化,NO16968:XELOX,辅助方案的新选择,Haller DG,Tabernero J,Maroun J,et al.Capecitabine Plus Oxaliplatin Compared With Fluorouracil and Folinic Acid As Adjuvant Therapy for Stage Colon Cancer J.Official Journal of the American Society of Clinical Oncology,2019,11(29):1465-71.,未接受过化放疗治疗的快速静推 5-FU/LVMayo C,3,年,DFS,4,年,DFS,5,年,DFS,7,年,DFS,XELOX,70.9%,68.4%,66.1%,63%,5-FU/LV,66.5%,62.3%,59.8%,56%,HR=0.80(95%CI:0.690.93),XELOX,较,5-FU/LV,在辅助化疗中，,DFS,和,OS,有显著优势,ITT,人群,估计的生存概率,(n=944),(n=942),3,年时的绝对差值,:,4.4%(p=0.0045),16968,研究显示：,XELOX,的,DFS,优势随观察时间延长而增加,Haller et al.JCO 2019;29:146571,5,年,OS,7,年,OS,XELOX,77.6%,73%,5-FU/LV,74.2%,67%,HR 0.83(95%CI 0.700.99),16968,研究显示：,XELOX,方案显著提高患者,7,年总生存率,4,年时的绝对差值,:6.1%,7,年时的绝对差值,:,7%(p=0.0038),5,年时的绝对差值,:6.3%(p=0.0045),月,月,5,年,OS,的绝对差值,:3.4%(p=0.1486),7,年,OS,的绝对差值,:6%(p=0.0367),3年DFS4年DFS5年DFS7年DFSXELOX70.9%,3,年,DFS,5,年,DFS,7,年,DFS,XELOX,70.9%,66.1%,63%,FOLFOX,72.2%,66.4%,-,1.,Haller et al.JCO 2019;29:146571,2.Andr T et al.Improved overall survival with oxaliplatin,fluorouracil,and leucovorin as adjuvant treatment in stage II or III colon cancer in the MOSAIC trial.J Clin Oncol 2009,27,310916.,5,年,OS,6,年,OS,7,年,OS,XELOX,77.6%,76%,73%,FOLFOX,-,72.9%,-,DFS,与,OS,曲线显示：,XELOX,方案与,FOLFOX,疗效相当,月,月,3年DFS5年DFS7年DFSXELOX70.9%66.1%,McCleary N.A.J,Meyerhardt J,Green E,et al.Impact of older age on the efficacy of newer adjuvant therapies in 12,500 patients(pts)with stage/colon cancer:Findings from the ACCENT Database.J Clin Oncol 27:15s,2009(suppl;abstr 4010).,Haller DG,Tabernero J,Maroun J,et al.Capecitabine Plus Oxaliplatin Compared With Fluorouracil and Folinic Acid As Adjuvant Therapy for Stage Colon Cancer J.Official Journal of the American Society of Clinical Oncology,2019,11(29):1465-71.,XELOX,方案使老年患者一致获益,*Values,1 favor oxaliplatin-based therapy vs.5-FU/LV;#Data for oxaliplatin-based regimens,风险比,(95%CIs),DFS,OS,ACCENT,分析,1,(FOLFOX/FLOX vs 5-Fu/Lv),70,岁,(n=3877),0.77(0.680.86),0.81(0.710.93),70 years(n=703),1.04(0.801.35),1.19(0.901.57),年龄和治疗交互分析，,p,值,0.016,0.037,NO.16968,研究,2,(XELOX vs 5-Fu/Lv),70,岁,(n=1477),0.79(0.660.94),0.86(0.691.08),70 years(n=409),0.87(0.631.18),0.94(0.661.34),年龄和治疗交互分析，,p,值,0.6222,0.7065,老年亚组分析显示：,XELOX,方案使老年患者一致获益,McCleary N.A.J,Meyerhardt J,1.Yothers et al.JCO 2019;28:376874,2.Tournigand et al.JCO 2019;28:15s(abstr 3522),NSABP C-07,1,MOSAIC,2,NO16968,FLOX*,FOLFOX*,XELOX*,年龄,岁,70,70,70,70,66,岁的患者,结肠癌术后辅助治疗,回顾性研究：研究设计,2019ASCOGI回顾性研究再次佐证XELOX方案可使老年,MOSAIC,(2009,年发表,),FOLFOX,5-FU/LV,(deGramont),NSABP C-07,(2019,年发表,),FLOX,5-FU/LV,(Roswell-Park),试验,对照组,新标准,X-ACT,(2019,年发表,),卡培他滨,5-FU/LV,(Mayo),5,年,DFS,提高,5.9%,4,年,DFS,提高,5.2%,5,年,DFS,提高,4.1%,XELOX,！,XELOX,方案超越,FOLFOX,，患者更多获益,5,年,DFS,提高,6.3%,16968,(2019,年发表,),5-FU/LV,(deGramont),MOSAICFOLFOX5-FU/LV(deGramont),XELOX,方案的血液学毒性显著低于,FOLFOX,方案,Schmoll HJ,Cartwright T,Tabernero J,et al.Phase Trial of Capecitabine Plus Oxaliplatin As Adjuvant Therapy for Stage Colon Cancer:A Planned Safety Analysis in 1,864 Patients J.Journal of Clinical Oncology,2019,25(1):102-9.,NO.16968,研究与,MOSAIC,研究的,3/4,级不良反应交叉对照分析,XELOX方案的血液学毒性显著低于FOLFOX方案Schmo,NCCN,指南推荐,:XELOX,是结直肠癌辅助化疗的标准方案,National Comprehensive Cancer Network.NCCN Clinical Practice Guidelines in Oncology Colon Cancer.V.3.2019:COL-4.,2019,结肠癌,NCCN,指南,XELOX,为,1,类推荐方案,2019,直肠癌,NCCN,指南,XELOX,为,2A,类推荐方案,NCCN指南推荐:XELOX 是结直肠癌辅助化疗的标准方案,中国卫生部颁发 结直肠癌诊疗规范（,20