xelox-结直肠癌患者辅助化疗的金标准课件

Click to edit Master title style,Click to edit Master text styles,Second level,Third level,Fourth level,Fifth level,18,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. 2001 Oct 11;345(15):1091-7,2, NCCN Clinical Practice Guideline in Oncology. Colon Cancer.,p,0.001,p,0.001,期、期结直肠癌患者,使用氟尿嘧啶为根底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,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, 2002, 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, 2021, 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,MOSAIC,(2021年发表),FOLFOX,5-FU/LV,(deGramont),NSABP,C-07,(2007,年发表,),FLOX,5-FU/LV,(Roswell-Park),试验,对照组,新标准,X-ACT,(2005,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,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,2003-2004,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, 2021, 11(29): 1465 - 71.,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 2021;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,DFS,5,年,DFS,7,年,DFS,XELOX,70.9%,66.1%,63%,FOLFOX,72.2%,66.4%,-,1. Haller et al. JCO 2021;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 2021,27,310916.,5,年,O,S,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,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, 2021 (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, 2021, 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,1. Yothers et al. JCO 2021;28:376874,2. Tournigand et al. JCO 2021;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,回忆性研究：研究设计,MOSAIC,(2021年发表),FOLFOX,5-FU/LV,(deGramont),NSABP,C-07,(2007,年发表,),FLOX,5-FU/LV,(Roswell-Park),试验,对照组,新标准,X-ACT,(2005,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,7,年,DFS,提高,7%,16968,(2021年发表),5-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, 2007, 25(1): 102 - 9.,NO.16968研究与MOSAIC研究的3/4级不良反响交叉对照分析,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.3.2021: COL-4.,2021结肠癌NCCN指南,XELOX为1类, 首选推荐方案,2021直肠癌NCCN指南,XELOX为2A类推荐方案,中国卫生部颁发 结直肠癌诊疗标准2021年版,使用方便,FOLFOX,指南推荐,疗效,XELOX,指南推荐,安全性更优,全人群适用,疗效确切,FOLFOX,XELOX,疗效,(5,年,DFS,差异值,),+5.9%,(Vs,LV5FU2),+6.3%,（,Vs 5-Fu/Lv),安全性,(,血液学毒性发生率,),43%,9.2%,适用人群,老年患者无,获益,(Vs,LV5FU2),全年龄人群一致获益,(Vs,5-FU/LV),指南推荐,1,类首选推荐,1,类首选推荐,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, 2007, 25(1): 102 - 9.,XELOX,超越,FOLFOX,成为,结肠癌,辅助治疗的金标准,XELOX,方案,是结直肠癌患者辅助化疗的,金,标准,用法用量：,静脉滴注 奥沙利铂,130 mg/m,2,(day 1),口服卡培他滨,1,000 mg/m,2,一天,2,次,(,第一天晚上至 第,15,天早上,) 6-8,片,/,天,每三周重复此方案，共治疗,8,个周期,1,2,3,4,5,6,7,第一周,上午,晚上,第二周,上午,晚上,第三周,上午,晚上,谢谢！,