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1、胃肠肿瘤 NCCN指南更新解读.内容20122012年结直肠癌年结直肠癌NCCNNCCN指南更新解读指南更新解读20112011年胃癌年胃癌NCCNNCCN指指南更新解读南更新解读.结直肠癌NCCN指南引荐主要更新20122012版结肠癌版结肠癌NCCNNCCN指南更新中,指南更新中,XELOXXELOX方案提升至方案提升至结肠癌辅结肠癌辅助化疗的助化疗的方案。方案。20122012版直肠癌版直肠癌NCCNNCCN指南更新中,卡培他滨单药指南更新中,卡培他滨单药提升至早提升至早期直肠癌期直肠癌同步放化疗同步放化疗,并成为指南,并成为指南。由于卡培他滨确切的疗效和耐受性,卡培他滨单药列为对不能由
2、于卡培他滨确切的疗效和耐受性,卡培他滨单药列为对不能耐受强烈化疗的晚期肠癌患者耐受强烈化疗的晚期肠癌患者之一之一SFDA未同意希罗达在结直肠癌中结合化疗的顺应症.2021年NCCN指南Capox方案引荐类别提升在在II II期高危患者的辅助化疗期高危患者的辅助化疗中添加了中添加了CapOxCapOx方案方案在在IIIIII期患者的辅助化疗中,期患者的辅助化疗中,CapOxCapOx方案提升为方案提升为I I类引荐类引荐对不耐受剧烈化疗的晚期结对不耐受剧烈化疗的晚期结肠癌患者,添加了卡培他滨肠癌患者,添加了卡培他滨贝伐单抗的引荐贝伐单抗的引荐SFDA未同意希罗达在结直肠癌中结合化疗的顺应症.卡培
3、他滨和Capox方案得到NCCN指南全面认可删除了删除了“ “卡培他滨结合化疗方案无成卡培他滨结合化疗方案无成熟数据的描画熟数据的描画交换为:交换为:“ “卡培他滨结合奥沙利铂优卡培他滨结合奥沙利铂优于静脉推注于静脉推注5-FU/LV5-FU/LVSFDA未同意希罗达在结直肠癌中结合化疗的顺应症.2021版结肠癌NCCN指南更新内容2021 结肠癌NCCN V32021 结肠癌NCCN V1II II期高危患者使用期高危患者使用卡培他滨单药卡培他滨单药二期高危患者可以二期高危患者可以使用使用CapoxCapox方案方案IIIIII期患者期患者CapoxCapox为为2A2A类推荐类推荐IIII
4、II期患者期患者CapoxCapox为为I I 类类推荐推荐SFDA未同意希罗达在结直肠癌中结合化疗的顺应症.3 3年年DFSDFS4 4年年DFSDFS5 5年年DFSDFS7 7年年DFSDFSXELOX70.9%68.4%66.1%63%5-FU/LV66.5%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 ITT 人群人群估计的生估计的生存概率存概率(n=944)(n=944)(n=942)(n=942)3 3年时的绝对差值年时的绝对差值: : 4.4% (p=0.0045)4.4%
5、(p=0.0045)月月16968研讨显示:XELOX的DFS优势随察看时间延伸而添加Haller et al. JCO 2021;29:1465715 5年年OSOS7 7年年OSOSXELOX77.6%73%5-FU/LV74.2%67%HR 0.83 (95% CI 0.700.99)16968研讨显示:XELOX方案显著提高患者7年总生存率4 4年时的绝对年时的绝对差值差值: 6.1%: 6.1%7 7年时的绝对差值年时的绝对差值: : 7% (p=0.0038)7% (p=0.0038)5 5年时的绝对差年时的绝对差值值: 6.3% : 6.3% (p=0.0045)(p=0.004
6、5)月月5 5年年OSOS的绝对差的绝对差值值: 3.4% : 3.4% (p=0.1486)(p=0.1486)7 7年年OSOS的绝对差的绝对差值值: 6% : 6% (p=0.0367)(p=0.0367)SFDA未同意希罗达在结直肠癌中结合化疗的顺应症.3年年DFS5年年DFS7年年DFSXELOX70.9%66.1%63%FOLFOX72.2%66.4%1. Haller et al. JCO 2021;29:1465712. Andr T et al. Improved overall survival with oxaliplatin, fluorouracil, and leu
7、covorin as adjuvant treatment in stage II or III colon cancer in the MOSAIC trial. J Clin Oncol 2021,27,310916. 5年年 OS6年年 OS7年年OSXELOX77.6%-73%FOLFOX-72.9%月月16968研讨与MOSAIC研讨交叉比较: DFS 与OS曲线显示XELOX方案与FOLFOX疗效相当SFDA未同意希罗达在结直肠癌中结合化疗的顺应症.卡培他滨结合同步放疗引荐级别全面提升病理病理II II期高危患者的辅助化疗中添加了卡期高危患者的辅助化疗中添加了卡培他滨同步放化的引荐
8、培他滨同步放化的引荐删除了删除了“ “卡培他滨同步放化无成熟卡培他滨同步放化无成熟IIIIII期随机期随机临床数据的描画临床数据的描画交换为交换为“ “卡培他滨同步放化在部分进展期直卡培他滨同步放化在部分进展期直肠癌有阳性临床结果肠癌有阳性临床结果IIIIII期期LARCLARC同步术前新辅助,卡培他滨结同步术前新辅助,卡培他滨结合放疗上升为合放疗上升为I I类证据,并优先引荐类证据,并优先引荐可同期手术切除的转移性直肠癌的初始治可同期手术切除的转移性直肠癌的初始治疗,添加了卡培他滨同步放化为优选方案疗,添加了卡培他滨同步放化为优选方案.2021版直肠癌NCCN指南更新内容2021 直肠癌NC
9、CN V42021 直肠癌NCCN V1卡培他滨是卡培他滨是II/IIIII/III期直肠癌新辅期直肠癌新辅助可选方案助可选方案卡培他滨是卡培他滨是II/IIIII/III期直肠癌新辅期直肠癌新辅助助优选优选方案方案卡培他滨是直卡培他滨是直肠癌辅助化疗肠癌辅助化疗可选方案可选方案卡培他滨是直卡培他滨是直肠癌辅助化疗肠癌辅助化疗优选优选方案方案.NSABP R-04实验 研讨设计 (2021 ASCO 报导)M. S. Roh, G. A. Yothers, et al. THE IMPACT OF CAPECITABINE AND OXALIPLATIN IN THE PREOPERATIVE
10、 MULTIMODALITY TREATMENT IN PATIENTS WITH CARCINOMA OF THE RECTUM: NSABP R-04. J Clin Oncol 29: 2021 (suppl; abstr 3503)stage/ 直肠癌(n=1608)u研讨终点研讨终点u外科降期外科降期(SD)(SD)、保肛手术、保肛手术(SSS)(SSS)、病理完全缓解率、病理完全缓解率(pCR)(pCR)u研讨目的研讨目的u经过比较卡培他滨和经过比较卡培他滨和5-FU5-FU在直肠癌患者术前新辅助治疗中的在直肠癌患者术前新辅助治疗中的疗效差别,以及比较在新辅助治疗中添加和不添加奥沙
11、利铂之疗效差别,以及比较在新辅助治疗中添加和不添加奥沙利铂之间的差别,从而察看卡培他滨和奥沙利铂在直肠癌术前综合治间的差别,从而察看卡培他滨和奥沙利铂在直肠癌术前综合治疗中的作用。疗中的作用。.NSABP R-04实验 研讨初步结果卡培他滨同步放化与静脉持续5-FU输注疗效相当,可以替代5-FU在直肠癌患者术前放化疗中,加用奥沙利铂不能获得临床获益,反而增加了毒性。M. S. Roh, G. A. Yothers, et al. THE IMPACT OF CAPECITABINE AND OXALIPLATIN IN THE PREOPERATIVE MULTIMODALITY TREATM
12、ENT IN PATIENTS WITH CARCINOMA OF THE RECTUM: NSABP R-04. J Clin Oncol 29: 2021 (suppl; abstr 3503)Endpoint Endpoint 5-FU (5-FU ( OX) OX) CAP CAP ( ( OX) OX) P value P value pCR pCR 18.8% 22.2% 0.12 SSS SSS 61.2% 62.7% 0.59 SD SD 20.7% 23.0% 0.62 Grade 3/4 Grade 3/4 diarrhea diarrhea 11.2% 10.8% 0.8
13、6 Endpoint Endpoint (FU or (FU or CAP) CAP) No OX No OX (FU or (FU or CAP) CAP) + OX + OX P value P value pCR pCR 19.1% 20.9% 0.46 SSS SSS 63.6% 60.4% 0.28 SD SD 23.0% 19.2% 0.48 Grade 3/4 Grade 3/4 diarrhea diarrhea 6.6% 15.4% 0.0001 .仅有肝和/或肺转移的结肠癌仅有同时性肝仅有同时性肝和和/ /或肺转移或肺转移可切除可切除1.1.新辅助化疗不再引荐新辅助化疗不再
14、引荐FOLFOX+FOLFOX+西妥昔单抗西妥昔单抗2.2.直接行手术治疗患者的术直接行手术治疗患者的术后化疗从参考晚期强化疗后化疗从参考晚期强化疗改为参考改为参考IIIIII期辅助化疗期辅助化疗无变化无变化20212021202120212021202120212021仅有异时性肝仅有异时性肝和和/ /或肺转移或肺转移新辅助治疗有效患新辅助治疗有效患者术后从反复初始者术后从反复初始治疗改为反复新辅治疗改为反复新辅助治疗或者助治疗或者FOLFOXFOLFOX不再引荐不再引荐FOLFOX+FOLFOX+西妥昔单抗西妥昔单抗1. 1. 有效、无效分别改为无进展有效、无效分别改为无进展和进展;和进展
15、;2. 2. 既往无化疗史的术后患者:既往无化疗史的术后患者:术后治疗从参考晚期强化术后治疗从参考晚期强化疗改为参考疗改为参考IIIIII期辅助化疗期辅助化疗3 . 3 . 不再引荐不再引荐FOLFOX+FOLFOX+西妥昔西妥昔单抗单抗不可切除不可切除无变化无变化可切除可切除不可切除不可切除无变化无变化不再引荐不再引荐FOLFOX+FOLFOX+西妥昔单抗西妥昔单抗.晚期结肠癌-可耐受强化疗.晚期结肠癌-不可耐受强化疗.仅有肝、肺转移的结肠癌仅有肝、肺转移的结肠癌 NCCN NCCN指南摘录指南摘录- -同时性、可切同时性、可切SFDA未同意希罗达在结直肠癌中结合化疗的顺应症.仅有肝、肺转移
16、的结肠癌仅有肝、肺转移的结肠癌 NCCN NCCN指南摘录指南摘录- -同时性、不可切同时性、不可切SFDA未同意希罗达在结直肠癌中结合化疗的顺应症.仅有肝、肺转移的结肠癌仅有肝、肺转移的结肠癌 NCCN NCCN指南摘录指南摘录- -异时性、可切异时性、可切.晚期结肠癌患者治疗2021202120212021晚期结晚期结肠癌肠癌可耐受可耐受强化疗强化疗不可耐不可耐受强化受强化疗疗添加卡培他滨添加卡培他滨单药单药+ +贝伐珠贝伐珠单抗单抗添加添加IROXIROX方案方案不再引荐不再引荐FOLFOX+FOLFOX+西妥昔西妥昔单抗联用单抗联用去除了卡培他滨单去除了卡培他滨单药药+ +贝伐珠单抗?
17、贝伐珠单抗?添加卡培他滨添加卡培他滨+ +贝贝伐珠单抗伐珠单抗1.1.添加了添加了FOLFOXFOLFOX和和FOLFIRI+FOLFIRI+帕尼单抗帕尼单抗WTWT2.2.去除去除CapeOX+CapeOX+西妥西妥昔单抗昔单抗3.3.一线一线FOLFOX+FOLFOX+贝伐贝伐珠单抗治疗进展后可珠单抗治疗进展后可思索运用思索运用FOLFIRI+FOLFIRI+帕帕尼单抗尼单抗WTWT添加了帕尼单抗的引添加了帕尼单抗的引荐荐WTWT20212021202120212021202120212021.mCRC一线治疗III期MAX研讨设计既往未曾治疗既往未曾治疗的无法手术的的无法手术的mCRCm
18、CRC患者患者n=471n=471RArm A:capecitabineq3w1 or 1.25mg/m2 daily d1-14n=156Arm BArm B:capecitabine+bevacizumabcapecitabine+bevacizumabq3wq3wbevacizumab 7.5mg/kg/3w d1bevacizumab 7.5mg/kg/3w d1n=157n=157Arm CArm C:CB+mitomycinCB+mitomycinmitomycin 7mg/m2 d1mitomycin 7mg/m2 d1* *n=158n=158l 主要终点:无进展存活期PFSl
19、 次要终点:OS,ORR,QOL,毒性*每6周给药一次,最大剂量14mg,最多给药4次Niall C. Tebbutt. J Clin Oncol. 2021 July 1(19):3191-3198.MAX研讨结果-PFSTubbut. ECCO 15-34th ESMO 2021. abstract O-6001.西妥昔单抗在mCRC一线治疗的关键临床研讨 COIN NORDIC .转移性结直肠癌一线治疗COIN研讨(III期): 西妥昔单抗 XELOX/FOLFOX主要终点: KRAS 野生型患者OS次要终点:KRAS突变型患者OS PFS缓解率延续延续XELOX XELOX 或或 FO
20、LFOX FOLFOXR R既往未曾治疗的既往未曾治疗的mCRCmCRC(n= 2445)(n= 2445)延续延续XELOX XELOX 或或 FOLFOX + FOLFOX + 西妥昔单抗西妥昔单抗延续延续* * *XELOX or FOLFOXXELOX or FOLFOX*Treatment until disease progression or unacceptable toxicity*Stop and Go treatment (12 wks then restart at progression)65% XELOX; 35% FOLFOXMaughan, et al. ECC
21、O-ESMO 2021 (abstract No. 6LBA)SFDA未同意希罗达在结直肠癌中结合化疗的顺应症.COIN研讨:KRAS野生型患者没有PFS 和OS获益SFDA未同意希罗达在结直肠癌中结合化疗的顺应症.NORDIC III期研讨设计既往未曾治疗既往未曾治疗的的mCRCmCRC患者患者n=566n=566R RArm AArm A:NORDIC FLOXNORDIC FLOXq2wq2wOxaliplatin 85mg/m2 d1Oxaliplatin 85mg/m2 d15 Fu bolus 500mg/m25 Fu bolus 500mg/m2,FA FA 60mg/m2 d1
22、-260mg/m2 d1-2; Arm BArm B:FLOX+cetuximabFLOX+cetuximab Initial dose400mg/m2 Initial dose400mg/m2 then 250mg/m2/week then 250mg/m2/week Arm C Arm C:FLOX for FLOX for 16weeks+cetuximab 16weeks+cetuximab continuouslycontinuouslyl 主要终点:无进展存活期PFSl 次要终点:PFS,ORRK. Tveit. J Clin Oncol 29: 2021(suppl 4; abs
23、tr 365R RArm AArm A:NORDIC FLOXNORDIC FLOXq2wq2wOxaliplatin 85mg/m2 d1Oxaliplatin 85mg/m2 d15 Fu bolus 500mg/m25 Fu bolus 500mg/m2,FA FA 60mg/m2 d1-260mg/m2 d1-2; Arm BArm B:FLOX+cetuximabFLOX+cetuximab Initial dose400mg/m2 Initial dose400mg/m2 then 250mg/m2/week then 250mg/m2/week Arm C Arm C:FLOX
24、for FLOX for 16weeks+cetuximab 16weeks+cetuximab continuouslycontinuously.NORDIC 研讨结果K. Tveit. J Clin Oncol 29: 2021(suppl 4; abstr 365.卡培他滨的运用引荐分期分期卡培他滨卡培他滨CAPOXCAPOX结肠癌II期2AII期高危2A2AIII期辅助2A1IV期新辅助/姑息2A2AIV期不可耐受强烈化疗2A直肠癌II/III期 新辅助 1 (Preferred)IIIII期辅助2A (Preferred)2AIV期新辅助/姑息2A (Preferred)2ASFDA
25、未同意希罗达在结直肠癌中结合化疗的顺应症.20112011年胃癌年胃癌NCCNNCCN指南更新解读指南更新解读.主要的更新主要的更新诊断诊断 AJCC分期采用第七版分期采用第七版 增加了内镜用于分期及治疗的推荐增加了内镜用于分期及治疗的推荐 扩充了扩充了HER2性的病理检测及治疗性的病理检测及治疗化疗化疗 卡培他滨卡培他滨可完全替换静脉输注可完全替换静脉输注5FU(除特殊说明外)(除特殊说明外) 指南分为一线,二线治疗以及替代疗法分别推荐指南分为一线,二线治疗以及替代疗法分别推荐, 多个含多个含 卡培他滨卡培他滨方案推荐强度上升方案推荐强度上升 紫杉在围手术期的应用推荐增加紫杉在围手术期的应用
26、推荐增加.HER-2HER-2检测初次引荐检测初次引荐.113ToGA 实验设计1.00.80.60.40.20.0363432302826242220181614121086420Time (months)11.816.0XP + TXPP294290HR0.6595% CI0.51, 0.83MedianOS16.011.8Event0.10.30.50.70.9218 19840531242011228 218196 170170 141142 112 12296100758453653951281000No. at risk39202813Phase III, randomized,
27、open-label, international, multicenter studySFDA未同意曲妥珠单抗用于胃癌的治疗.除特别注明外,卡培他滨可替代静脉输注除特别注明外,卡培他滨可替代静脉输注5FU5FU源于源于REAL-2和和ML17032的的Meta分析等众多含卡培他分析等众多含卡培他滨临床研讨滨临床研讨.存活率存活率%治疗的总生存治疗的总生存OS随机化后时间年随机化后时间年P=0.02701325461008060402005-FU 中位中位OS 258d, 95%CI(265-305d)Cape 中位中位OS 322d, 95%CI(300-343d)Okines AF, et
28、 al. Ann Oncol. 2021 Sep;20(9):1529-34. REAL2/ML17032荟萃分析:比较治疗晚期胃荟萃分析:比较治疗晚期胃-食管癌的含卡食管癌的含卡培他滨方案与含培他滨方案与含5-FU方案方案.亚组分析结果显示含卡培他滨的方案较在亚组分析结果显示含卡培他滨的方案较在老年患者中有疗效更好的趋势老年患者中有疗效更好的趋势Okines AF, et al. Ann Oncol. 2021 Sep;20(9):1529-34. 卡培他滨更好卡培他滨更好 风险比风险比 5-FU更好更好卡培他滨结卡培他滨结合对合对60方方案的患者案的患者风险值更低风险值更低PS 0-1PS
29、 1Age 60Age 60部分进展期组部分进展期组转移组转移组总体疗效总体疗效0.50 0.60 0.70 0.80 0.90 1.00 1.10 1.20 1.30 1.400.40.卡培他滨参与的卡培他滨参与的PhaseIIIPhaseIII临床研讨临床研讨Year临床研究临床研究研究类型研究类型基础方案基础方案联合靶向联合靶向2008REAL-2Phase IIIEOX Vs ECF-2009ToGAPhase IIIXP/FPTrastuzumab2009ML17032Phase IIIXP Vs FP-2009Meta分析Meta分析X Vs 5-Fu-2010AVAGASTPha
30、se IIIXPBevacizumab2011ClassicPhase IIIXelox-2011ARTISTPhase IIIXP(放疗)ongoingREAL 3Phase IIIEOXPanitumumabongoingEXPANDPhase IIIXPCetuximabongoingMagic-BPhase IIIECXAvastinongoingLOGICPhase IIIXeloxLapatinibSFDA未同意曲妥珠单抗用于胃癌的治疗SFDA未同意希罗达用于早期胃癌的治疗.围手术期化疗更新围手术期化疗更新Version 2.2010, 02/26/10 2010 National
31、 Comprehensive Cancer Network, Inc. All rights reserved. These guidelines and this illustration may not be reproduced in any form without the express written permission of NCCN.N CCNPractice Guidelinesin Oncology v.2.2010Guidelines IndexGastric Cancer Table of ContentsStaging, Discussion, References
32、Gastric CancerPRINCIPLES OF SYSTEMIC THERAPY FOR GASTRICOR GASTROESOPHAGEAL JUNCTIONADENOCARCINOMA (1 of 2)Note: All recommendations are category 2A unless otherwise indicated.Clinical Trials: NCCN believes that the best management of any cancer patient is in a clinical trial. Participation in clini
33、cal trials is especially encouraged.GAST-C(1 of 2)For metastatic gastric or gastroesophageal junction adenocarcinoma, some regimens listed below represent institutional preferen ces andmay not be superior to the category 1 regimens.Please refer to the original reports for specifiPlease refer to the
34、Principles of Radiation Therapy for the radiation therapy administration details.Prior to recommending chemotherapy, the requirements for the adequacy of organ function and performance status should be met.The schedule, toxicity, and potential benefits from chemotherapy should be thoroughly discusse
35、d with the patient andPatienteducation should also include the discussion of precautions and measures to reduce the severity and duration of complications.During chemotherapy, patients should be observed closely, treated for any complications, and appropriate blood work should bemonitored.Upon compl
36、etion of chemotherapy, patients should be evaluated for response and any long-term complications., and dose modifications.caregivers.c toxicity, doses, schedule()GAST-DReferences on next pageMetastatic or Locally Advanced Cancer(where chemoradiation is not recommended):DCF (Docetaxel, cisplatin and
37、5-FU) (category 1)ECF (category 1)ECF modifications (category 1)Irinotecan plus cisplatin (category 2B)Oxaliplatin plus fluoropyrimidine (5-FU or capecitabine) (category 2B)DCF modifications (category 2B)Irinotecan plus fluoropyrimidine (5-FU or capecitabine) (category 2B)Paclitaxel-based regimen (c
38、ategory 2B)Trastuzumab672,8,910,118,122,13,14,1516,17,18Preoperative and Postoperative ChemotherapyPreoperative ChemoradiationPostoperative Chemoradiation(GE junction adenocarcinoma included):ECF (Epirubicin, cisplatin and 5-FU) (category 1)ECF modifications (category 1):Docetaxel or paclitaxel plus
39、 fluoropyrimidine(5-FU or capecitabine) (category 2B)Cisplatin plus fluoropyrimidine (category 2B)(GE junction adenocarcinoma included)Fluoropyrimidine (5-FU or capecitabine) (category 1)11,2345Leucovorin is indicated with certain infusional 5-FU-based regimens.Used in combination with systemic chem
40、otherapy for the treatment of patients with advanced gastric cancer or GE junction adenoc arcinoma that is HER-2-positive asdetermined by a standardized method.Version 2.2010, 02/26/10 2010 National Comprehensive Cancer Network, Inc. All rights reserved. These guidelines and this illustration may no
41、t be reproduced in any form without the express written permission of NCCN.N C C NPractice Guidelinesin Oncology v.2.2010Guidelines IndexGastric Cancer Table of ContentsStaging, Discussion, ReferencesGastric CancerPRINCIPLES OF SYSTEMIC THERAPY FOR GASTRICOR GASTROESOPHAGEAL JUNCTIONADENOCARCINOMA (
42、1 of 2)Note: All recommendations are category 2A unless otherwise indicated.Clinical Trials: NCCN believes that the best management of any cancer patient is in a clinical trial. Participation in clinical trials is especially encouraged.GAST-C(1 of 2)For metastatic gastric or gastroesophageal junctio
43、n adenocarcinoma, some regimens listed below represent institutional preferen ces andmay not be superior to the category 1 regimens.Please refer to the original reports for specifiPlease refer to the Principles of Radiation Therapy for the radiation therapy administration details.Prior to recommendi
44、ng chemotherapy, the requirements for the adequacy of organ function and performance status should be met.The schedule, toxicity, and potential benefits from chemotherapy should be thoroughly discussed with the patient andPatienteducation should also include the discussion of precautions and measure
45、s to reduce the severity and duration of complications.During chemotherapy, patients should be observed closely, treated for any complications, and appropriate blood work should bemonitored.Upon completion of chemotherapy, patients should be evaluated for response and any long-term complications., a
46、nd dose modifications.caregivers.c toxicity, doses, schedule()GAST-DReferences on next pageMetastatic or Locally Advanced Cancer(where chemoradiation is not recommended):DCF (Docetaxel, cisplatin and 5-FU) (category 1)ECF (category 1)ECF modifications (category 1)Irinotecan plus cisplatin (category
47、2B)Oxaliplatin plus fluoropyrimidine (5-FUor capecitabine) (category 2B)DCF modifications (category 2B)Irinotecan plus fluoropyrimidine (5-FU or capecitabine) (category 2B)Paclitaxel-based regimen (category 2B)Trastuzumab672,8,910,118,122,13,14,1516,17,18Preoperative and Postoperative ChemotherapyPr
48、eoperative ChemoradiationPostoperative Chemoradiation(GE junction adenocarcinoma included):ECF (Epirubicin, cisplatin and 5-FU) (category 1)ECF modifications (category 1):Docetaxel or paclitaxel plus fluoropyrimidine(5-FU or capecitabine) (category 2B)Cisplatin plus fluoropyrimidine (category 2B)(GE
49、 junction adenocarcinoma included)Fluoropyrimidine (5-FU or capecitabine) (category 1)11,2345Leucovorin is indicated with certain infusional 5-FU-based regimens.Used in combination with systemic chemotherapy for the treatment of patients with advanced gastric cancer or GE junction adenoc arcinoma th
50、at is HER-2-positive asdetermined by a standardized method.Version 2.2010, 02/26/10 2010 National Comprehensive Cancer Network, Inc. All rights reserved. These guidelines and this illustration may not be reproduced in any form without the express written permission of NCCN.N CCNPractice Guidelinesin
51、 Oncology v.2.2010Guidelines IndexGastric Cancer Table of ContentsStaging, Discussion, ReferencesGastric CancerPRINCIPLES OF SYSTEMIC THERAPY FOR GASTRICOR GASTROESOPHAGEAL JUNCTIONADENOCARCINOMA (1 of 2)Note: All recommendations are category 2A unless otherwise indicated.Clinical Trials: NCCN belie
52、ves that the best management of any cancer patient is in a clinical trial. Participation in clinical trials is especially encouraged.GAST-C(1 of 2)For metastatic gastric or gastroesophageal junction adenocarcinoma, some regimens listed below represent institutional preferen ces andmay not be superio
53、r to the category 1 regimens.Please refer to the original reports for specifiPlease refer to the Principles of Radiation Therapy for the radiation therapy administration details.Prior to recommending chemotherapy, the requirements for the adequacy of organ function and performance status should be m
54、et.The schedule, toxicity, and potential benefits from chemotherapy should be thoroughly discussed with the patient andPatienteducation should also include the discussion of precautions and measures to reduce the severity and duration of complications.During chemotherapy, patients should be observed
55、 closely, treated for any complications, and appropriate blood work should bemonitored.Upon completion of chemotherapy, patients should be evaluated for response and any long-term complications., and dose modifications.caregivers.c toxicity, doses, schedule()GAST-DReferences on next pageMetastatic o
56、r Locally Advanced Cancer(where chemoradiation is not recommended):DCF (Docetaxel, cisplatin and 5-FU) (category 1)ECF (category 1)ECF modifications (category 1)Irinotecan plus cisplatin (category 2B)Oxaliplatin plus fluoropyrimidine (5-FU or capecitabine) (category 2B)DCF modifications (category 2B
57、)Irinotecan plus fluoropyrimidine (5-FU or capecitabine) (category 2B)Paclitaxel-based regimen (category 2B)Trastuzumab672,8,910,118,122,13,14,1516,17,18Preoperative and Postoperative ChemotherapyPreoperative ChemoradiationPostoperative Chemoradiation(GE junction adenocarcinoma included):ECF (Epirub
58、icin, cisplatin and 5-FU) (category 1)ECF modifications (category 1):Docetaxel or paclitaxel plus fluoropyrimidine(5-FU or capecitabine) (category 2B)Cisplatin plus fluoropyrimidine (category 2B)(GE junction adenocarcinoma included)Fluoropyrimidine (5-FU or capecitabine) (category 1)11,2345Leucovori
59、n is indicated with certain infusional 5-FU-based regimens.Used in combination with systemic chemotherapy for the treatment of patients with advanced gastric cancer or GE junction adenocarcinoma that is HER-2-positive asdetermined by a standardized method.l术后术后:l引荐引荐5FULv 在输注在输注5FU前后或卡培他滨结合前后或卡培他滨结合
60、放疗放疗l紫杉醇紫杉醇5FU进入术后放化疗引荐进入术后放化疗引荐l术前术前:l顺铂含氟嘧啶类包括卡培他滨方案上升为顺铂含氟嘧啶类包括卡培他滨方案上升为术前放化疗一类证据术前放化疗一类证据l多西紫杉醇和伊利替康进入术前放化疗多西紫杉醇和伊利替康进入术前放化疗2B2021Version NCCNSFDA未同意希罗达用于早期胃癌的治疗.顺铂5FU(含卡培他滨)方案上升为术前放化疗一类证据多西紫杉醇和伊利替康进入术前放化疗2B 源于以下研究数据方案方案XP+放疗放疗(n=19 M1a)XP+放疗放疗(n=29 M1b)XP(n=26 M1b)FP+放疗放疗(n=30)IP+放疗放疗(n=44)多西紫杉
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