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1、胃腸腫瘤 NCCN指南更新解讀 內(nèi)容 20122012年結(jié)直腸癌年結(jié)直腸癌 NCCNNCCN指南更新解讀指南更新解讀 20112011年胃癌年胃癌NCCNNCCN指指 南更新解讀南更新解讀 結(jié)直腸癌NCCN指南推薦主要更新 20122012版結(jié)腸癌版結(jié)腸癌NCCNNCCN指南更新中,指南更新中,XELOXXELOX方案提升至方案提升至結(jié)腸癌輔結(jié)腸癌輔 助化療的助化療的方案。方案。 20122012版直腸癌版直腸癌NCCNNCCN指南更新中,卡培他濱單藥指南更新中,卡培他濱單藥提升至早提升至早 期直腸癌期直腸癌同步放化療同步放化療,并成為指南,并成為指南。 由于卡培他濱確切的療效和耐受性,卡培他
2、濱單藥列為對(duì)不能由于卡培他濱確切的療效和耐受性,卡培他濱單藥列為對(duì)不能 耐受強(qiáng)烈化療的晚期腸癌患者耐受強(qiáng)烈化療的晚期腸癌患者之一之一 SFDA未批準(zhǔn)希羅達(dá)在結(jié)直腸癌中聯(lián)合化療的適應(yīng)癥 2012年NCCN指南Capox方案推薦類別提升 在在II II期高?;颊叩妮o助化療期高?;颊叩妮o助化療 中增加了中增加了CapOxCapOx方案方案 在在IIIIII期患者的輔助化療中,期患者的輔助化療中, CapOxCapOx方案提升為方案提升為I I類推薦類推薦 對(duì)不耐受強(qiáng)烈化療的晚期結(jié)對(duì)不耐受強(qiáng)烈化療的晚期結(jié) 腸癌患者,增加了卡培他濱腸癌患者,增加了卡培他濱 貝伐單抗的推薦貝伐單抗的推薦 SFDA未批準(zhǔn)希
3、羅達(dá)在結(jié)直腸癌中聯(lián)合化療的適應(yīng)癥 卡培他濱和Capox方案得到NCCN指南全面認(rèn)可 刪除了刪除了“ “卡培他濱聯(lián)合化療方案無(wú)成卡培他濱聯(lián)合化療方案無(wú)成 熟數(shù)據(jù)熟數(shù)據(jù)” ”的描述的描述 替換為:替換為:“ “卡培他濱聯(lián)合奧沙利鉑優(yōu)卡培他濱聯(lián)合奧沙利鉑優(yōu) 于靜脈推注于靜脈推注5-FU/LV5-FU/LV” ” SFDA未批準(zhǔn)希羅達(dá)在結(jié)直腸癌中聯(lián)合化療的適應(yīng)癥 2012版結(jié)腸癌NCCN指南更新內(nèi)容 2011 結(jié)腸癌NCCN V32012 結(jié)腸癌NCCN V1 II II期高?;颊呤褂闷诟呶;颊呤褂?卡培他濱單藥卡培他濱單藥 二期高?;颊呖梢远诟呶;颊呖梢?使用使用CapoxCapox方案方案 II
4、IIII期患者期患者CapoxCapox為為 2A2A類推薦類推薦 IIIIII期患者期患者CapoxCapox為為I I 類類推薦推薦 SFDA未批準(zhǔn)希羅達(dá)在結(jié)直腸癌中聯(lián)合化療的適應(yīng)癥 3 3年年DFSDFS 4 4年年 DFSDFS 5 5年年DFSDFS 7 7年年 DFSDFS XELOX70.9%68.4%66.1%63% 5- FU/LV 66.5%62.3%59.8%56% HR=0.80 (95% CI: 0.690.93) XELOX較5-FU/LV在輔助化療中, DFS和OS有顯著優(yōu)勢(shì) ITT ITT 人群人群 估計(jì)的生估計(jì)的生 存概率存概率 (n=944)(n=944)
5、(n=942)(n=942) 3 3年時(shí)的絕對(duì)差值年時(shí)的絕對(duì)差值: : 4.4% (p=0.0045)4.4% (p=0.0045) 月月 16968研究顯示:XELOX的 DFS優(yōu)勢(shì)隨觀察時(shí)間延長(zhǎng)而增加 Haller et al. JCO 2011;29:146571 5 5年年OSOS7 7年年OSOS XELOX77.6%73% 5-FU/LV74.2%67% HR 0.83 (95% CI 0.700.99) 16968研究顯示:XELOX方 案顯著提高患者7年總生存 率 4 4年時(shí)的絕對(duì)年時(shí)的絕對(duì) 差值差值: 6.1%: 6.1% 7 7年時(shí)的絕對(duì)差值年時(shí)的絕對(duì)差值: : 7% (p
6、=0.0038)7% (p=0.0038) 5 5年時(shí)的絕對(duì)差年時(shí)的絕對(duì)差 值值: 6.3% : 6.3% (p=0.0045)(p=0.0045) 月月 5 5年年OSOS的絕對(duì)差的絕對(duì)差 值值: 3.4% : 3.4% (p=0.1486)(p=0.1486) 7 7年年OSOS的絕對(duì)差的絕對(duì)差 值值: 6% : 6% (p=0.0367)(p=0.0367) SFDA未批準(zhǔn)希羅達(dá)在結(jié)直腸癌中聯(lián)合化療的適應(yīng)癥 3年年DFS5年年DFS7年年DFS XELOX70.9%66.1%63% FOLFOX72.2%66.4% 1. Haller et al. JCO 2011;29:146571
7、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年年 OS6年年 OS7年年OS XELOX77.6%-73% FOLFOX-72.9% 月月 16968研究與MOSAIC研究交叉比較: DFS 與OS曲線顯示XELOX方案與FOLFOX療效相當(dāng) SFDA未
8、批準(zhǔn)希羅達(dá)在結(jié)直腸癌中聯(lián)合化療的適應(yīng)癥 卡培他濱聯(lián)合同步放療推薦級(jí)別全面提升 病理病理II II期高危患者的輔助化療中增加了卡期高?;颊叩妮o助化療中增加了卡 培他濱同步放化的推薦培他濱同步放化的推薦 刪除了刪除了“ “卡培他濱同步放化無(wú)成熟卡培他濱同步放化無(wú)成熟IIIIII期隨機(jī)期隨機(jī) 臨床數(shù)據(jù)臨床數(shù)據(jù)” ”的描述的描述 替換為替換為“ “卡培他濱同步放化在局部進(jìn)展期直卡培他濱同步放化在局部進(jìn)展期直 腸癌有陽(yáng)性臨床結(jié)果腸癌有陽(yáng)性臨床結(jié)果” ” IIIIII期期LARCLARC同步術(shù)前新輔助,卡培他濱聯(lián)同步術(shù)前新輔助,卡培他濱聯(lián) 合放療上升為合放療上升為I I類證據(jù),并優(yōu)先推薦類證據(jù),并優(yōu)先推薦
9、 可同期手術(shù)切除的轉(zhuǎn)移性直腸癌的初始治可同期手術(shù)切除的轉(zhuǎn)移性直腸癌的初始治 療,增加了卡培他濱同步放化為優(yōu)選方案療,增加了卡培他濱同步放化為優(yōu)選方案 2012版直腸癌NCCN指南更新內(nèi)容 2011 直腸癌NCCN V42012 直腸癌NCCN V1 卡培他濱是卡培他濱是II/IIIII/III 期直腸癌新輔期直腸癌新輔 助可選方案助可選方案 卡培他濱是卡培他濱是II/IIIII/III 期直腸癌新輔期直腸癌新輔 助助優(yōu)選優(yōu)選方案方案 卡培他濱是直卡培他濱是直 腸癌輔助化療腸癌輔助化療 可選方案可選方案 卡培他濱是直卡培他濱是直 腸癌輔助化療腸癌輔助化療 優(yōu)選優(yōu)選方案方案 NSABP R-04試
10、驗(yàn) 研究設(shè)計(jì) (2011 ASCO 報(bào)導(dǎo)) M. S. Roh, G. A. Yothers, et al. THE IMPACT OF CAPECITABINE AND OXALIPLATIN IN THE PREOPERATIVE MULTIMODALITY TREATMENT IN PATIENTS WITH CARCINOMA OF THE RECTUM: NSABP R-04. J Clin Oncol 29: 2011 (suppl; abstr 3503) stage / u研究終點(diǎn)研究終點(diǎn) u研究目的研究目的 NSABP R-04試驗(yàn) 研究初步結(jié)果 卡培他濱同步放化與靜脈持續(xù)5
11、- FU輸注療效相當(dāng),可以替代5-FU 在直腸癌患者術(shù)前放化療中,加用 奧沙利鉑不能獲得臨床獲益,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 TREATMENT IN PATIENTS WITH CARCINOMA OF THE RECTUM: NSABP R-04. J Clin Oncol 29: 2011 (suppl; abstr 3503) Endpoint Endpoint 5-FU (5
12、-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% 0.86 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
13、% 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 僅有肝和/或肺轉(zhuǎn)移的結(jié)腸癌 僅有同時(shí)性肝僅有同時(shí)性肝 和和/ /或肺轉(zhuǎn)移或肺轉(zhuǎn)移 可切除可切除 1.1.新輔助化療不再推薦新輔助化療不再推薦 FOLFOX+FOLFOX+西妥昔單抗西妥昔單抗 2.2.直接行手術(shù)治療患者的術(shù)直接行手術(shù)治療患者的術(shù) 后化療從參考晚期強(qiáng)化療后化療從參考晚期強(qiáng)化療 改為參考改為參考IIIIII期輔助化療期輔助化療 無(wú)變化無(wú)變化 20102011201
14、020112011201220112012 僅有異時(shí)性肝僅有異時(shí)性肝 和和/ /或肺轉(zhuǎn)移或肺轉(zhuǎn)移 新輔助治療有效患新輔助治療有效患 者術(shù)后從重復(fù)初始者術(shù)后從重復(fù)初始 治療改為重復(fù)新輔治療改為重復(fù)新輔 助治療或者助治療或者 FOLFOXFOLFOX 不再推薦不再推薦FOLFOX+FOLFOX+西妥昔單抗西妥昔單抗 1. 1. 有效、無(wú)效分別改為無(wú)進(jìn)展有效、無(wú)效分別改為無(wú)進(jìn)展 和進(jìn)展;和進(jìn)展; 2. 2. 既往無(wú)化療史的術(shù)后患者:既往無(wú)化療史的術(shù)后患者: 術(shù)后治療從參考晚期強(qiáng)化術(shù)后治療從參考晚期強(qiáng)化 療改為參考療改為參考IIIIII期輔助化療期輔助化療 3 . 3 . 不再推薦不再推薦FOLFOX
15、+FOLFOX+西妥昔西妥昔 單抗單抗 不可切除不可切除無(wú)變化無(wú)變化 可切除可切除 不可切除不可切除 無(wú)變化無(wú)變化 不再推薦不再推薦FOLFOX+FOLFOX+西妥昔單抗西妥昔單抗 晚期結(jié)腸癌-可耐受強(qiáng)化療 晚期結(jié)腸癌-不可耐受強(qiáng)化療 僅有肝、肺轉(zhuǎn)移的結(jié)腸癌僅有肝、肺轉(zhuǎn)移的結(jié)腸癌 NCCN NCCN指南摘錄指南摘錄 - -同時(shí)性、可切同時(shí)性、可切 SFDA未批準(zhǔn)希羅達(dá)在結(jié)直腸癌中聯(lián)合化療的適應(yīng)癥 僅有肝、肺轉(zhuǎn)移的結(jié)腸癌僅有肝、肺轉(zhuǎn)移的結(jié)腸癌 NCCN NCCN指南摘錄指南摘錄 - -同時(shí)性、不可切同時(shí)性、不可切 SFDA未批準(zhǔn)希羅達(dá)在結(jié)直腸癌中聯(lián)合化療的適應(yīng)癥 僅有肝、肺轉(zhuǎn)移的結(jié)腸癌僅有肝、肺
16、轉(zhuǎn)移的結(jié)腸癌 NCCN NCCN指南摘錄指南摘錄 - -異時(shí)性、可切異時(shí)性、可切 晚期結(jié)腸癌患者治療 2009201020092010 晚期結(jié)晚期結(jié) 腸癌腸癌 可耐受可耐受 強(qiáng)化療強(qiáng)化療 不可耐不可耐 受強(qiáng)化受強(qiáng)化 療療 增加卡培他濱增加卡培他濱 單藥單藥+ +貝伐珠貝伐珠 單抗單抗 增加增加IROXIROX方案方案 不再推薦不再推薦 FOLFOX+FOLFOX+西妥昔西妥昔 單抗聯(lián)用單抗聯(lián)用 去除了卡培他濱單去除了卡培他濱單 藥藥+ +貝伐珠單抗?貝伐珠單抗? 增加卡培他濱增加卡培他濱+ +貝貝 伐珠單抗伐珠單抗 1.1.增加了增加了FOLFOXFOLFOX和和 FOLFIRI+FOLFIR
17、I+帕尼單抗帕尼單抗 (WTWT) 2.2.去除去除CapeOX+CapeOX+西妥西妥 昔單抗昔單抗 3.3.一線一線FOLFOX+FOLFOX+貝伐貝伐 珠單抗治療進(jìn)展后可珠單抗治療進(jìn)展后可 考慮使用考慮使用FOLFIRI+FOLFIRI+帕帕 尼單抗(尼單抗(WTWT) 增加了帕尼單抗的推增加了帕尼單抗的推 薦)(薦)(WTWT) 20102011201020112011201220112012 mCRC一線治療III期MAX研究設(shè)計(jì) 既往未曾治療既往未曾治療 的無(wú)法手術(shù)的的無(wú)法手術(shù)的 mCRCmCRC患者患者 (n=471n=471) R Arm A: capecitabine(q3w
18、) (n=156) Arm BArm B: capecitabine+bevacizumabcapecitabine+bevacizumab (q3wq3w) (n=157n=157) Arm CArm C: CB+mitomycinCB+mitomycin mitomycin 7mg/m2 d1mitomycin 7mg/m2 d1* * (n=158n=158) l 主要終點(diǎn):無(wú)進(jìn)展存活期(PFS) l 次要終點(diǎn):OS,ORR,QOL,毒性 *每6周給藥一次,最大劑量14mg,最多給藥4次 Niall C. Tebbutt. J Clin Oncol. 2010 July 1(19):31
19、91-3198 MAX研究結(jié)果-PFS Tubbut. ECCO 15-34th ESMO 2009. abstract O-6001 西妥昔單抗在mCRC一線治療的關(guān)鍵臨床研究 COIN NORDIC 轉(zhuǎn)移性結(jié)直腸癌一線治療 COIN研究(III期): 西妥昔單抗 XELOX/FOLFOX 主要終點(diǎn): KRAS 野生型患者OS 次要終點(diǎn): KRAS突變型患者OS PFS 緩解率 連續(xù)連續(xù)XELOX XELOX 或或 FOLFOXFOLFOX R R 既往未曾治療的既往未曾治療的mCRCmCRC (n= 2445)(n= 2445) 連續(xù)連續(xù)XELOX XELOX 或或 FOLFOX + FO
20、LFOX + 西妥昔單抗西妥昔單抗 間斷間斷* * * 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% FOLFOX Maughan, et al. ECCO-ESMO 2009 (abstract No. 6LBA) SFDA未批準(zhǔn)希羅達(dá)在結(jié)直腸癌中聯(lián)合化療的適應(yīng)癥 COIN研究:KRAS野生型患者沒(méi)有PFS
21、 和OS獲益 SFDA未批準(zhǔn)希羅達(dá)在結(jié)直腸癌中聯(lián)合化療的適應(yīng)癥 NORDIC (III期)研究設(shè)計(jì) 既往未曾治療既往未曾治療 的的mCRCmCRC患者患者 (n=566n=566) R R Arm AArm A:NORDIC FLOXNORDIC FLOX (q2wq2w) Oxaliplatin 85mg/m2 d1Oxaliplatin 85mg/m2 d1 5 Fu bolus 500mg/m25 Fu bolus 500mg/m2, FA 60mg/m2 d1-2FA 60mg/m2 d1-2; Arm BArm B:FLOX+cetuximabFLOX+cetuximab Initi
22、al 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 continuouslycontinuously l 主要終點(diǎn):無(wú)進(jìn)展存活期(PFS) l 次要終點(diǎn):PFS,ORR K. Tveit. J Clin Oncol 29: 2011(suppl 4; abstr 365) R R Arm AArm A:NORDIC FLOXNORDIC FLOX(q2wq2w) Ox
23、aliplatin 85mg/m2 d1Oxaliplatin 85mg/m2 d1 5 Fu bolus 500mg/m25 Fu bolus 500mg/m2, FA 60mg/m2 d1-2FA 60mg/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
24、 continuouslycontinuously NORDIC 研究結(jié)果 K. Tveit. J Clin Oncol 29: 2011(suppl 4; abstr 365) 卡培他濱的應(yīng)用推薦 分期分期卡培他濱卡培他濱CAPOXCAPOX 結(jié)腸癌 II期2A II期高危2A2A III期輔助2A1 IV期新輔助/姑息2A2A IV期不可耐受強(qiáng)烈化療2A 直腸癌 II/III期 新輔助 1 (Preferred) IIIII期輔助2A (Preferred)2A IV期新輔助/姑息2A (Preferred)2A SFDA未批準(zhǔn)希羅達(dá)在結(jié)直腸癌中聯(lián)合化療的適應(yīng)癥 20112011年胃癌年胃
25、癌NCCNNCCN指南更新解讀指南更新解讀 主要的更新主要的更新 診斷診斷 AJCC分期采用第七版分期采用第七版 增加了內(nèi)鏡用于分期及治療的推薦增加了內(nèi)鏡用于分期及治療的推薦 擴(kuò)充了擴(kuò)充了HER2性的病理檢測(cè)及治療性的病理檢測(cè)及治療 化療化療 卡培他濱卡培他濱可完全替換靜脈輸注可完全替換靜脈輸注5FU(除特殊說(shuō)明外)(除特殊說(shuō)明外) 指南分為一線,二線治療以及替代療法分別推薦指南分為一線,二線治療以及替代療法分別推薦, 多個(gè)含多個(gè)含 卡培他濱卡培他濱方案推薦強(qiáng)度上升方案推薦強(qiáng)度上升 紫杉在圍手術(shù)期的應(yīng)用推薦增加紫杉在圍手術(shù)期的應(yīng)用推薦增加 HER-2HER-2檢測(cè)首次推薦檢測(cè)首次推薦 11 3
26、 ToGA 試驗(yàn)設(shè)計(jì) 363432302826242220181614121086420 Time (months) XP + T XP P 294 290 HR95% CI Median OS Event 218 1984 0 5 3 12 4 20 11 228 218196 170170 141142 112 122 96 100 75 84 53 65 39 51 28 1 0 0 0 No. at risk 39 20 28 13 Phase III, randomized, open-label, international, multicenter study SFDA未批準(zhǔn)曲妥
27、珠單抗用于胃癌的治療 除特別注明外,卡培他濱可替代靜脈輸注除特別注明外,卡培他濱可替代靜脈輸注5FU5FU 源于源于REAL-2和和ML17032的的 Meta分析分析等眾多含卡培他等眾多含卡培他 濱臨床研究濱臨床研究 存活率(存活率(%) 治療的總生存(治療的總生存(OS) 隨機(jī)化后時(shí)間(年)隨機(jī)化后時(shí)間(年) 0132546 100 80 60 40 20 0 5-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 al. Ann Oncol. 2009 Sep;20(9):1529
28、-34. REAL2/ML17032薈萃分析:比較治療晚期胃薈萃分析:比較治療晚期胃-食管癌的含卡食管癌的含卡 培他濱方案與含培他濱方案與含5-FU方案方案 亞組分析結(jié)果顯示含卡培他濱的方案較在亞組分析結(jié)果顯示含卡培他濱的方案較在 老年患者中有療效更好的趨勢(shì)老年患者中有療效更好的趨勢(shì) Okines AF, et al. Ann Oncol. 2009 Sep;20(9):1529-34. 卡培他濱更好卡培他濱更好 風(fēng)險(xiǎn)比風(fēng)險(xiǎn)比 5-FU更好更好 卡培他濱聯(lián)卡培他濱聯(lián) 合對(duì)合對(duì)60方方 案的患者案的患者 風(fēng)險(xiǎn)值更低風(fēng)險(xiǎn)值更低 PS 0-1 PS 1 Age 60 Age 60 局部進(jìn)展期組局部進(jìn)
29、展期組 轉(zhuǎn)移組轉(zhuǎn)移組 總體療效總體療效 0.50 0.60 0.70 0.80 0.90 1.00 1.10 1.20 1.30 1.400.40 卡培他濱參與的卡培他濱參與的PhaseIII臨床研究臨床研究 Year臨床研究臨床研究研究類型研究類型基礎(chǔ)方案基礎(chǔ)方案聯(lián)合靶向聯(lián)合靶向 2008REAL-2Phase III EOX Vs ECF - 2009ToGAPhase IIIXP/FPTrastuzumab 2009ML17032Phase IIIXP Vs FP- 2009Meta分析Meta分析X Vs 5-Fu- 2010AVAGASTPhase IIIXPBevacizumab
30、2011ClassicPhase IIIXelox- 2011ARTISTPhase IIIXP(放療) ongoingREAL 3Phase IIIEOXPanitumumab ongoingEXPANDPhase IIIXPCetuximab ongoingMagic-BPhase III ECX Avastin ongoingLOGICPhase IIIXeloxLapatinib SFDA未批準(zhǔn)曲妥珠單抗用于胃癌的治療 SFDA未批準(zhǔn)希羅達(dá)用于早期胃癌的治療 圍手術(shù)期化療更新圍手術(shù)期化療更新 Version 2.2010, 02/26/10 2010 National Comprehe
31、nsive 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 CCN Practice Guidelines in Oncology v.2.2010 Guidelines Index Gastric Cancer Table of Contents Staging, Discussion, ReferencesGas
32、tric Cancer PRINCIPLES OF SYSTEMIC THERAPY FOR GASTRIC OR 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 clin
33、ical trials is especially encouraged. GAST-C (1 of 2) For metastatic gastric or gastroesophageal junction adenocarcinoma, some regimens listed below represent institutional preferen ces and may not be superior to the category 1 regimens. Please refer to the original reports for specifi Please refer
34、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 met. The schedule, toxicity, and potential benefits from chemotherapy should be thoroughly
35、 discussed with the patient andPatient education 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 be monitore
36、d. Upon completion of chemotherapy, patients should be evaluated for response and any long-term complications. , and dose modifications. caregivers. c toxicity, doses, schedule ()GAST-D References on next page Metastatic or Locally Advanced Cancer (where chemoradiation is not recommended): DCF (Doce
37、taxel, 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) Irinotecan plus fluoropyrimidine (5-FU or capecitabine) (category 2B)
38、 Paclitaxel-based regimen (category 2B) Trastuzumab 6 7 2,8,9 10,11 8,12 2,13,14,15 16,17 ,18 Preoperative and Postoperative Chemotherapy Preoperative Chemoradiation Postoperative Chemoradiation (GE junction adenocarcinoma included): ECF (Epirubicin, cisplatin and 5-FU) (category 1) ECF modification
39、s (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) 1 1,2 3 4 5 Leucovorin is indicated with certain infusional 5-F
40、U-based regimens. Used in combination with systemic chemotherapy for the treatment of patients with advanced gastric cancer or GE junction adenoc arcinoma that is HER-2-positive as determined by a standardized method. Version 2.2010, 02/26/10 2010 National Comprehensive Cancer Network, Inc. All righ
41、ts reserved. These guidelines and this illustration may not be reproduced in any form without the express written permission of NCCN. N C C N Practice Guidelines in Oncology v.2.2010 Guidelines Index Gastric Cancer Table of Contents Staging, Discussion, ReferencesGastric Cancer PRINCIPLES OF SYSTEMI
42、C THERAPY FOR GASTRIC OR 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 clinical trials is especially encoura
43、ged. GAST-C (1 of 2) For metastatic gastric or gastroesophageal junction adenocarcinoma, some regimens listed below represent institutional preferen ces and may not be superior to the category 1 regimens. Please refer to the original reports for specifi Please refer to the Principles of Radiation Th
44、erapy 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 discussed with the patient andPa
45、tient education 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 be monitored. Upon completion of chemotherap
46、y, patients should be evaluated for response and any long-term complications. , and dose modifications. caregivers. c toxicity, doses, schedule ()GAST-D References on next page Metastatic or Locally Advanced Cancer (where chemoradiation is not recommended): DCF (Docetaxel, cisplatin and 5-FU) (categ
47、ory 1) ECF (category 1) ECF modifications (category 1) Irinotecan plus cisplatin (category 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 (categor
48、y 2B) Trastuzumab 6 7 2,8,9 10,11 8,12 2,13,14,15 16,17 ,18 Preoperative and Postoperative Chemotherapy Preoperative Chemoradiation Postoperative Chemoradiation (GE junction adenocarcinoma included): ECF (Epirubicin, cisplatin and 5-FU) (category 1) ECF modifications (category 1) : Docetaxel or pacl
49、itaxel plus fluoropyrimidine (5-FU or capecitabine) (category 2B) Cisplatin plus fluoropyrimidine (category 2B) (GE junction adenocarcinoma included) Fluoropyrimidine (5-FU or capecitabine) (category 1) 1 1,2 3 4 5 Leucovorin is indicated with certain infusional 5-FU-based regimens. Used in combinat
50、ion with systemic chemotherapy for the treatment of patients with advanced gastric cancer or GE junction adenoc arcinoma that is HER-2-positive as determined by a standardized method. Version 2.2010, 02/26/10 2010 National Comprehensive Cancer Network, Inc. All rights reserved. These guidelines and
51、this illustration may not be reproduced in any form without the express written permission of NCCN. N CCN Practice Guidelines in Oncology v.2.2010 Guidelines Index Gastric Cancer Table of Contents Staging, Discussion, ReferencesGastric Cancer PRINCIPLES OF SYSTEMIC THERAPY FOR GASTRIC OR GASTROESOPH
52、AGEAL 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 clinical trials is especially encouraged. GAST-C (1 of 2) For metastatic
53、gastric or gastroesophageal junction adenocarcinoma, some regimens listed below represent institutional preferen ces and may not be superior to the category 1 regimens. Please refer to the original reports for specifi Please refer to the Principles of Radiation Therapy for the radiation therapy admi
54、nistration 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 discussed with the patient andPatient education should also include
55、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 be monitored. Upon completion of chemotherapy, patients should be evaluated for
56、response and any long-term complications. , and dose modifications. caregivers. c toxicity, doses, schedule ()GAST-D References on next page Metastatic or Locally Advanced Cancer (where chemoradiation is not recommended): DCF (Docetaxel, cisplatin and 5-FU) (category 1) ECF (category 1) ECF modifica
57、tions (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 (category 2B) Trastuzumab 6 7 2,8,9 10,11 8
58、,12 2,13,14,15 16,17 ,18 Preoperative and Postoperative Chemotherapy Preoperative Chemoradiation Postoperative Chemoradiation (GE junction adenocarcinoma included): ECF (Epirubicin, cisplatin and 5-FU) (category 1) ECF modifications (category 1) : Docetaxel or paclitaxel plus fluoropyrimidine (5-FU
59、or capecitabine) (category 2B) Cisplatin plus fluoropyrimidine (category 2B) (GE junction adenocarcinoma included) Fluoropyrimidine (5-FU or capecitabine) (category 1) 1 1,2 3 4 5 Leucovorin is indicated with certain infusional 5-FU-based regimens. Used in combination with systemic chemotherapy for
60、the treatment of patients with advanced gastric cancer or GE junction adenocarcinoma that is HER-2-positive as determined by a standardized method. l術(shù)后術(shù)后: 推薦推薦5FULv 在輸注在輸注5FU前后或卡培他濱前后或卡培他濱 聯(lián)合放療聯(lián)合放療 紫杉醇紫杉醇5FU進(jìn)入術(shù)后放化療推薦進(jìn)入術(shù)后放化療推薦 l術(shù)術(shù)前前: 順鉑順鉑含氟嘧啶類包括卡培他濱方案上升含氟嘧啶類包括卡培他濱方案上升 為術(shù)前放化療一類證據(jù)為術(shù)前放化療一類證據(jù) 多西紫杉醇和伊利替康進(jìn)
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