1、從規(guī)范化資料解讀看胃癌綜合治療經(jīng)常涉及的相關(guān)規(guī)范化資料：經(jīng)常涉及的相關(guān)規(guī)范化資料：lAJCC 分期分期 7th edition ，2010，10 UICClNCCN指南，指南， 2011，3 NCCN 美國國家癌癥綜合網(wǎng)絡(luò)美國國家癌癥綜合網(wǎng)絡(luò)lESMO指南，指南，2010，8 ESMO 歐洲臨床腫瘤學(xué)會(huì)歐洲臨床腫瘤學(xué)會(huì)l衛(wèi)生部胃癌診療規(guī)范，衛(wèi)生部胃癌診療規(guī)范， 2011，3 衛(wèi)生部醫(yī)政司牽頭，國內(nèi)衛(wèi)生部醫(yī)政司牽頭，國內(nèi)30余位專家參與（外科、內(nèi)科、放射診斷、余位專家參與（外科、內(nèi)科、放射診斷、放射治療、病理等）制定了胃腺癌，包括胃食管結(jié)合部癌的診斷、放射治療、病理等）制定了胃腺癌，包括胃食管結(jié)

2、合部癌的診斷、治療和隨訪原則，適用于具備相應(yīng)資質(zhì)的衛(wèi)生機(jī)構(gòu)及其醫(yī)務(wù)人員對(duì)治療和隨訪原則，適用于具備相應(yīng)資質(zhì)的衛(wèi)生機(jī)構(gòu)及其醫(yī)務(wù)人員對(duì)胃癌的診斷和治療胃癌的診斷和治療推薦級(jí)別推薦級(jí)別衛(wèi)生部胃癌診療規(guī)衛(wèi)生部胃癌診療規(guī)范范NCCNESMOl必須必須l建議建議l酌情使用酌情使用/考慮考慮l不推薦不推薦推薦級(jí)別來自推薦級(jí)別來自ASCO標(biāo)準(zhǔn)：標(biāo)準(zhǔn)：l 1類：類： 基于高水平證據(jù)基于高水平證據(jù)(如隨機(jī)如隨機(jī)對(duì)照試驗(yàn)對(duì)照試驗(yàn))提出的建議，專家組提出的建議，專家組一致同意。一致同意。l 2A類：基于低水平證據(jù)提出的類：基于低水平證據(jù)提出的建議，專家組一致同意。建議，專家組一致同意。l 2B類：基于低水平證據(jù)提出的

3、類：基于低水平證據(jù)提出的建議，專家組基本同意，無明顯建議，專家組基本同意，無明顯分歧。分歧。l 3類：類： 基于任何水平證據(jù)提出基于任何水平證據(jù)提出的建議，專家組意見存在明顯的的建議，專家組意見存在明顯的分歧。分歧。除非特別之處，除非特別之處，NCCN對(duì)所有建對(duì)所有建議均達(dá)成議均達(dá)成2A類共識(shí)。類共識(shí)。推薦級(jí)別和推薦級(jí)別和NCCN一致，一致，為為ASCO標(biāo)準(zhǔn)標(biāo)準(zhǔn)另注明證據(jù)級(jí)別：另注明證據(jù)級(jí)別：l I：所有：所有RCT的系統(tǒng)評(píng)價(jià)或的系統(tǒng)評(píng)價(jià)或Meta分析；分析；l II：單個(gè)的大樣本：單個(gè)的大樣本 RCTl III：有對(duì)照但未隨機(jī)：有對(duì)照但未隨機(jī) Traill IV：無對(duì)照的系列病例觀察：無對(duì)照

4、的系列病例觀察無特別注明級(jí)別之描述，是無特別注明級(jí)別之描述，是ESMO專家認(rèn)為的臨床標(biāo)準(zhǔn)專家認(rèn)為的臨床標(biāo)準(zhǔn)l治療原則治療原則l診斷與分期診斷與分期l早期胃癌，手術(shù)及相關(guān)早期胃癌，手術(shù)及相關(guān)l系統(tǒng)化療總則系統(tǒng)化療總則l圍手術(shù)期化療圍手術(shù)期化療l姑息化療姑息化療 一線一線 二線化療二線化療ref：衛(wèi)生部胃癌診療規(guī)范：衛(wèi)生部胃癌診療規(guī)范治療原則治療原則l 應(yīng)采取綜合治療的原則，即根據(jù)腫瘤病理學(xué)類型及臨床分應(yīng)采取綜合治療的原則，即根據(jù)腫瘤病理學(xué)類型及臨床分期，結(jié)合患者一般狀況和器官功能狀態(tài)，以手術(shù)、化療、期，結(jié)合患者一般狀況和器官功能狀態(tài)，以手術(shù)、化療、放療乃至生物靶向治療等多學(xué)科綜合治療模式放療乃至

5、生物靶向治療等多學(xué)科綜合治療模式（multidisciplinary team，MDT），有計(jì)劃地、合理地應(yīng)），有計(jì)劃地、合理地應(yīng)用治療手段，以期達(dá)到：用治療手段，以期達(dá)到： 根治或根治或 最大幅度地控制腫瘤最大幅度地控制腫瘤 延長患者生存期延長患者生存期 改善生活質(zhì)量改善生活質(zhì)量ref：衛(wèi)生部胃癌診療規(guī)范：衛(wèi)生部胃癌診療規(guī)范近年來胃癌治療最大的進(jìn)展是通過胃癌圍手術(shù)期治療和輔助放化療的綜合治近年來胃癌治療最大的進(jìn)展是通過胃癌圍手術(shù)期治療和輔助放化療的綜合治療模式明顯改善患者的生存期療模式明顯改善患者的生存期NCCNNCCN 指南指南結(jié)合外科、化療和放療醫(yī)生，消化、影像和病理科的多學(xué)科綜合治療是

6、必不結(jié)合外科、化療和放療醫(yī)生，消化、影像和病理科的多學(xué)科綜合治療是必不可少的可少的ESMOESMO（歐洲臨床腫瘤學(xué)會(huì)）臨床診斷、治療和隨訪指南（歐洲臨床腫瘤學(xué)會(huì)）臨床診斷、治療和隨訪指南 胃癌治療應(yīng)是以手術(shù)治療為主的綜合治療胃癌治療應(yīng)是以手術(shù)治療為主的綜合治療胃癌診療推薦流程胃癌診療推薦流程ref：衛(wèi)生部胃癌診療規(guī)范：衛(wèi)生部胃癌診療規(guī)范診斷與分期診斷與分期l分類標(biāo)準(zhǔn)：分類標(biāo)準(zhǔn)：WHO胃癌組織學(xué)分類胃癌組織學(xué)分類l分期診斷標(biāo)準(zhǔn)：分期診斷標(biāo)準(zhǔn)：AJCC TNM分期標(biāo)準(zhǔn)（分期標(biāo)準(zhǔn)（2010年）年）l病理學(xué)描述：另有附錄病理學(xué)描述：另有附錄ref：衛(wèi)生部胃癌診療規(guī)范：衛(wèi)生部胃癌診療規(guī)范衛(wèi)生部胃癌診療規(guī)

7、范采用以下標(biāo)準(zhǔn)：衛(wèi)生部胃癌診療規(guī)范采用以下標(biāo)準(zhǔn)：腔鏡檢查腔鏡檢查l胃鏡檢查：確診胃癌的胃鏡檢查：確診胃癌的必須檢查手段必須檢查手段，可確定腫瘤位置，可確定腫瘤位置，同時(shí)獲得組織標(biāo)本以行病理檢查；可酌情選用色素內(nèi)鏡或同時(shí)獲得組織標(biāo)本以行病理檢查；可酌情選用色素內(nèi)鏡或放大內(nèi)鏡檢查放大內(nèi)鏡檢查l超聲胃鏡檢查：推薦用于胃癌的術(shù)前分期，有助于評(píng)價(jià)胃超聲胃鏡檢查：推薦用于胃癌的術(shù)前分期，有助于評(píng)價(jià)胃癌浸潤深度和判斷胃周淋巴結(jié)轉(zhuǎn)移狀況。對(duì)擬施行內(nèi)鏡粘癌浸潤深度和判斷胃周淋巴結(jié)轉(zhuǎn)移狀況。對(duì)擬施行內(nèi)鏡粘膜切除（膜切除（EMR）、內(nèi)鏡粘膜下層切除（）、內(nèi)鏡粘膜下層切除（ESD）者等微創(chuàng)手）者等微創(chuàng)手術(shù)者術(shù)者則為必

8、須則為必須l腹腔鏡：對(duì)懷疑腹膜轉(zhuǎn)移或腹腔內(nèi)播散者，腹腔鏡：對(duì)懷疑腹膜轉(zhuǎn)移或腹腔內(nèi)播散者，可考慮可考慮腹腔鏡腹腔鏡檢查檢查ref：衛(wèi)生部胃癌診療規(guī)范：衛(wèi)生部胃癌診療規(guī)范組織病理學(xué)診斷組織病理學(xué)診斷l(xiāng)組織病理學(xué)診斷是胃癌的確診和治療依據(jù)。活檢確診為浸組織病理學(xué)診斷是胃癌的確診和治療依據(jù)?；顧z確診為浸潤性癌的病例進(jìn)行規(guī)范化治療潤性癌的病例進(jìn)行規(guī)范化治療l如因活檢取材的限制，活檢病理不能確定浸潤深度。報(bào)告如因活檢取材的限制，活檢病理不能確定浸潤深度。報(bào)告為癌前病變或可疑浸潤的病例，為癌前病變或可疑浸潤的病例，建議建議臨床醫(yī)師重復(fù)活檢或臨床醫(yī)師重復(fù)活檢或結(jié)合影像學(xué)檢查情況，進(jìn)一步確診后選擇治療方案結(jié)合影

9、像學(xué)檢查情況，進(jìn)一步確診后選擇治療方案ref：衛(wèi)生部胃癌診療規(guī)范：衛(wèi)生部胃癌診療規(guī)范影像學(xué)檢查（影像學(xué)檢查（1）l CT： 應(yīng)作為胃癌術(shù)前分期的常規(guī)方法。在無造影劑使用禁應(yīng)作為胃癌術(shù)前分期的常規(guī)方法。在無造影劑使用禁忌癥情況下，忌癥情況下，建議建議在胃腔呈良好充盈狀態(tài)下進(jìn)行在胃腔呈良好充盈狀態(tài)下進(jìn)行增強(qiáng)增強(qiáng)CT掃掃描。掃描部位應(yīng)包括原發(fā)部位及可能的轉(zhuǎn)移部位描。掃描部位應(yīng)包括原發(fā)部位及可能的轉(zhuǎn)移部位l 磁共振（磁共振（MRI）檢查：是重要的補(bǔ)充手段。推薦以下情）檢查：是重要的補(bǔ)充手段。推薦以下情況選用：況選用： 對(duì)對(duì)CT造影劑過敏者造影劑過敏者 其它影像學(xué)檢查懷疑轉(zhuǎn)移者，如肝轉(zhuǎn)移、卵巢轉(zhuǎn)移等其它

10、影像學(xué)檢查懷疑轉(zhuǎn)移者，如肝轉(zhuǎn)移、卵巢轉(zhuǎn)移等 MRI有助于判斷腹膜轉(zhuǎn)移狀態(tài)，可酌情使用有助于判斷腹膜轉(zhuǎn)移狀態(tài)，可酌情使用ref：衛(wèi)生部胃癌診療規(guī)范：衛(wèi)生部胃癌診療規(guī)范l上消化道造影：氣鋇雙重對(duì)比造影檢查是診斷胃癌的常用上消化道造影：氣鋇雙重對(duì)比造影檢查是診斷胃癌的常用影像學(xué)方法，對(duì)疑幽門梗阻者建議使用水溶性造影劑影像學(xué)方法，對(duì)疑幽門梗阻者建議使用水溶性造影劑l 胸部胸部X線檢查：應(yīng)包括正線檢查：應(yīng)包括正側(cè)側(cè)位相位相l(xiāng)超聲檢查：對(duì)評(píng)價(jià)胃癌局部淋巴結(jié)轉(zhuǎn)移情況及表淺部位的超聲檢查：對(duì)評(píng)價(jià)胃癌局部淋巴結(jié)轉(zhuǎn)移情況及表淺部位的轉(zhuǎn)移有一定價(jià)值，可作為術(shù)前分期的初步檢查方法。但對(duì)轉(zhuǎn)移有一定價(jià)值，可作為術(shù)前分期的

11、初步檢查方法。但對(duì)操作者的依賴性較強(qiáng)，重復(fù)性欠佳操作者的依賴性較強(qiáng)，重復(fù)性欠佳影像學(xué)檢查（影像學(xué)檢查（2）ref：衛(wèi)生部胃癌診療規(guī)范：衛(wèi)生部胃癌診療規(guī)范影像學(xué)檢查（影像學(xué)檢查（3）lPET-CT：對(duì)判斷腹膜轉(zhuǎn)移的價(jià)值有待進(jìn)一步明確，：對(duì)判斷腹膜轉(zhuǎn)移的價(jià)值有待進(jìn)一步明確，目前不目前不推薦常規(guī)使用推薦常規(guī)使用。對(duì)常規(guī)影像學(xué)檢查無法明確的轉(zhuǎn)移性病灶，。對(duì)常規(guī)影像學(xué)檢查無法明確的轉(zhuǎn)移性病灶，可酌情使用可酌情使用l骨掃描：骨掃描：不推薦常規(guī)使用不推薦常規(guī)使用，對(duì)懷疑有骨轉(zhuǎn)移的胃癌患者，對(duì)懷疑有骨轉(zhuǎn)移的胃癌患者，可考慮骨掃描檢查可考慮骨掃描檢查ref：衛(wèi)生部胃癌診療規(guī)范：衛(wèi)生部胃癌診療規(guī)范診斷與分期診斷與

12、分期 in NCCN 2011.v.11. CT/US pelvis (females) 中國專家意見：中國專家意見：should be added 3. Feasibility and necessity of meta biopsy? 中國專家意見：必要時(shí)中國專家意見：必要時(shí) 2. PET scan not feasible in china中國專家意見：中國專家意見：should be optional 強(qiáng)調(diào) HER2 Test in Metastatic DiseaseESMO和和NCCN在分期與手術(shù)的差異在分期與手術(shù)的差異距腫瘤組織5厘米距腫瘤組織4厘米根治手術(shù)切緣AJCC第6版ES

13、MOAJCC第7版NCCN分期距腫瘤組織5厘米距腫瘤組織4厘米根治手術(shù)切緣AJCC第6版ESMOAJCC第7版NCCN分期Progression for AJCC/UICC TNM Staging System2010200219975th edition6th edition7th editionUICC 和和 AJCC分期是一致的分期是一致的 國際抗癌聯(lián)盟國際抗癌聯(lián)盟International Union Against Cancer，UICC國際抗癌聯(lián)盟腫瘤國際抗癌聯(lián)盟腫瘤TNM分期分期 美國癌癥聯(lián)合委員會(huì)美國癌癥聯(lián)合委員會(huì) American Joint Committee on Can

14、cer, AJCC AJCC癌癥分期手冊(cè)癌癥分期手冊(cè)T 分期變化6 6thth Edition Edition7 7thth Edition EditionT1T1粘膜層粘膜層 MucosaMucosaT1aT1a粘膜下層粘膜下層 SubmucosaSubmucosaT1bT1bT2aT2a肌層肌層 MusclMuscl. Propria. PropriaT2T2T2bT2b漿膜下層漿膜下層 SubserosaSubserosaT3T3T3T3漿膜層漿膜層 SerosaSerosaT4aT4aT4T4鄰近臟器鄰近臟器 InvasionInvasionT4bT4bMucosaMucosaSubm

15、ucosaSubmucosaMuscl. PropriaMuscl. PropriaSubserosaSubserosa粘膜肌層漿膜表面自由腹腔鄰近臟器T1T2T3T46th 7th 6th 7th 6th 7th 6th 7th N 分期變化6th Edition7th EditionN0N00 0N0N0N1N11-21-2N1N13-63-6N2N2N2N27-157-15N3aN3aN3N31616N3bN3bM 分期取消 Mx 的定義 (遠(yuǎn)處轉(zhuǎn)移無法評(píng)估)2010年年CSCO年會(huì)年會(huì)早期胃癌早期胃癌l 早期胃癌且無淋巴結(jié)轉(zhuǎn)移證據(jù)，可根據(jù)侵犯深度考慮內(nèi)鏡早期胃癌且無淋巴結(jié)轉(zhuǎn)移證據(jù)，可根

16、據(jù)侵犯深度考慮內(nèi)鏡下治療或手術(shù)治療，術(shù)后無需輔助放療或化療下治療或手術(shù)治療，術(shù)后無需輔助放療或化療l EMR或或ESD適應(yīng)證為適應(yīng)證為 高分化或中分化高分化或中分化 無潰瘍無潰瘍 直徑在直徑在2 cm內(nèi)內(nèi) 無淋巴結(jié)轉(zhuǎn)移的黏膜內(nèi)癌無淋巴結(jié)轉(zhuǎn)移的黏膜內(nèi)癌ref：衛(wèi)生部胃癌診療規(guī)范：衛(wèi)生部胃癌診療規(guī)范可切除胃癌的外科治療可切除胃癌的外科治療身體狀況身體狀況良好，有良好，有切除可能切除可能M0M1T1b姑息治療姑息治療首選多學(xué)首選多學(xué)科評(píng)估科評(píng)估T2或或T2以上以上（根據(jù)臨床（根據(jù)臨床分期或分期或N+）手術(shù)手術(shù)手術(shù)手術(shù)或或術(shù)前化療（術(shù)前化療（1類）類）或或術(shù)前化放療術(shù)前化放療（2b類類) 手術(shù)手術(shù)可切

17、除胃癌的外科治療可切除胃癌的外科治療l T1b-T3：足夠的胃切除以達(dá)到顯微鏡下切緣陰性：足夠的胃切除以達(dá)到顯微鏡下切緣陰性（一般距腫瘤邊緣（一般距腫瘤邊緣5cm）遠(yuǎn)端胃切除術(shù)胃次全切除術(shù)全胃切除術(shù)l T4腫瘤需要將累及組織整塊切除腫瘤需要將累及組織整塊切除l常規(guī)或預(yù)防性脾切除無必要。當(dāng)脾臟或脾門受累時(shí)常規(guī)或預(yù)防性脾切除無必要。當(dāng)脾臟或脾門受累時(shí)可以考慮脾切除術(shù)可以考慮脾切除術(shù)l陽性切緣定義陽性切緣定義*：腫瘤距切緣小于腫瘤距切緣小于1mm或電刀切緣可見或電刀切緣可見癌細(xì)胞癌細(xì)胞 * 衛(wèi)生部胃癌診療規(guī)范衛(wèi)生部胃癌診療規(guī)范淋巴結(jié)淋巴結(jié)l建議外科醫(yī)師根據(jù)局部解剖和術(shù)中所見，分組送檢淋巴結(jié)，建議外科

18、醫(yī)師根據(jù)局部解剖和術(shù)中所見，分組送檢淋巴結(jié)，有利于淋巴結(jié)引流區(qū)域的定位有利于淋巴結(jié)引流區(qū)域的定位l在未接到手術(shù)醫(yī)師分組送檢醫(yī)囑或標(biāo)記的情況下，病理醫(yī)在未接到手術(shù)醫(yī)師分組送檢醫(yī)囑或標(biāo)記的情況下，病理醫(yī)師按照以下原則檢出標(biāo)本中的淋巴結(jié)：師按照以下原則檢出標(biāo)本中的淋巴結(jié)：l全部淋巴結(jié)均需取材全部淋巴結(jié)均需取材l建議建議術(shù)前未接受治療病例的淋巴結(jié)總數(shù)應(yīng)術(shù)前未接受治療病例的淋巴結(jié)總數(shù)應(yīng)15枚枚l所有肉眼陰性的淋巴結(jié)應(yīng)當(dāng)所有肉眼陰性的淋巴結(jié)應(yīng)當(dāng)完整送檢完整送檢l肉眼陽性的淋巴結(jié)肉眼陽性的淋巴結(jié)可部分切取送檢可部分切取送檢ref：衛(wèi)生部胃癌診療規(guī)范：衛(wèi)生部胃癌診療規(guī)范lNCCN指南指南: 淋巴結(jié)清掃范圍應(yīng)包

19、括區(qū)域淋巴結(jié)淋巴結(jié)清掃范圍應(yīng)包括區(qū)域淋巴結(jié)-胃周淋巴胃周淋巴結(jié)（結(jié)（D1）和腹腔干周圍同名血管的淋巴結(jié)（）和腹腔干周圍同名血管的淋巴結(jié)（D2），且至少），且至少切除切除15枚淋巴結(jié)枚淋巴結(jié)lESMO指南對(duì)淋巴結(jié)的清掃范圍和數(shù)目同指南對(duì)淋巴結(jié)的清掃范圍和數(shù)目同NCCN指南指南手術(shù)禁忌證手術(shù)禁忌證l全身狀況惡化無法耐受手術(shù)全身狀況惡化無法耐受手術(shù)l局部浸潤過于廣泛己無法切除局部浸潤過于廣泛己無法切除l己有遠(yuǎn)處轉(zhuǎn)移的確切證據(jù)，包括多發(fā)淋巴結(jié)轉(zhuǎn)移、腹膜廣己有遠(yuǎn)處轉(zhuǎn)移的確切證據(jù)，包括多發(fā)淋巴結(jié)轉(zhuǎn)移、腹膜廣泛播散和肝臟多灶性（泛播散和肝臟多灶性（3個(gè)以上）轉(zhuǎn)移等個(gè)以上）轉(zhuǎn)移等l心、肺、肝、腎等重要臟器功能

20、有明顯缺陷，嚴(yán)重的低蛋心、肺、肝、腎等重要臟器功能有明顯缺陷，嚴(yán)重的低蛋白血癥和貧血、營養(yǎng)不良無耐受手術(shù)之可能者白血癥和貧血、營養(yǎng)不良無耐受手術(shù)之可能者ref：衛(wèi)生部胃癌診療規(guī)范：衛(wèi)生部胃癌診療規(guī)范lAcknowledgement of AJCC 2010 Staging Modifications公認(rèn)采用AJCC 7.0版，但關(guān)于EGJ的分期如何劃分東西方存在爭議lGAST-3: A new page, outlining post surgery therapy for pts not receiving preop中國多數(shù)患者術(shù)前未行新輔助治療，術(shù)后治療有規(guī)可依lPrinciples o

21、f Endoscopic Therapy: Role of endoscopic mucosal resection for T1a tumors內(nèi)鏡的診斷、分期、早期癌切除及營養(yǎng)路徑置入lPathologic review: inclusion of HER2 testing明確內(nèi)鏡標(biāo)本、手術(shù)標(biāo)本的取材要求、描述，從大體標(biāo)本到病理組織學(xué)均細(xì)化規(guī)定，要求描述新輔助治療療效等美國美國NCCN 2011.v.1 更新更新 外科部分外科部分Positive peritoneal cytology is now Stage 4: Surgery NOT recommended 不能切除的，不能切除的，

22、初始初始治療后再治療后再評(píng)估是否能夠評(píng)估是否能夠切除切除!進(jìn)展期胃癌進(jìn)展期胃癌l局部進(jìn)展期胃癌或伴有淋巴結(jié)轉(zhuǎn)移的早期胃癌應(yīng)采取以手術(shù)局部進(jìn)展期胃癌或伴有淋巴結(jié)轉(zhuǎn)移的早期胃癌應(yīng)采取以手術(shù)為主的綜合治療為主的綜合治療l根據(jù)腫瘤侵犯深度及是否伴有淋巴結(jié)轉(zhuǎn)移，可考慮直接進(jìn)行根據(jù)腫瘤侵犯深度及是否伴有淋巴結(jié)轉(zhuǎn)移，可考慮直接進(jìn)行根治性手術(shù)或術(shù)前先行新輔助化療，再考慮根治性手術(shù)根治性手術(shù)或術(shù)前先行新輔助化療，再考慮根治性手術(shù)l成功實(shí)施根治性手術(shù)的局部進(jìn)展期胃癌，需根據(jù)術(shù)后病理分成功實(shí)施根治性手術(shù)的局部進(jìn)展期胃癌，需根據(jù)術(shù)后病理分期決定輔助治療方案（輔助化療，必要時(shí)考慮輔助化放療）期決定輔助治療方案（輔助化療

23、，必要時(shí)考慮輔助化放療）ref：衛(wèi)生部胃癌診療規(guī)范：衛(wèi)生部胃癌診療規(guī)范系統(tǒng)化療總述系統(tǒng)化療總述l分為新輔助化療、輔助化療和姑息化療分為新輔助化療、輔助化療和姑息化療l應(yīng)嚴(yán)格掌握臨床適應(yīng)證應(yīng)嚴(yán)格掌握臨床適應(yīng)證l應(yīng)充分考慮患者病期、體力狀況、不良反應(yīng)、生活質(zhì)量及應(yīng)充分考慮患者病期、體力狀況、不良反應(yīng)、生活質(zhì)量及患者意愿，避免治療過度或治療不足患者意愿，避免治療過度或治療不足l應(yīng)及時(shí)評(píng)估化療療效，密切監(jiān)測(cè)及防治不良反應(yīng)，并酌情應(yīng)及時(shí)評(píng)估化療療效，密切監(jiān)測(cè)及防治不良反應(yīng)，并酌情調(diào)整藥物和（或）劑量調(diào)整藥物和（或）劑量l療效評(píng)價(jià)標(biāo)準(zhǔn)可參照療效評(píng)價(jià)標(biāo)準(zhǔn)可參照RECIST療效評(píng)價(jià)標(biāo)準(zhǔn)或療效評(píng)價(jià)標(biāo)準(zhǔn)或WHO實(shí)

24、體瘤實(shí)體瘤療效評(píng)價(jià)標(biāo)準(zhǔn)療效評(píng)價(jià)標(biāo)準(zhǔn)l不良反應(yīng)評(píng)價(jià)標(biāo)準(zhǔn)參照不良反應(yīng)評(píng)價(jià)標(biāo)準(zhǔn)參照NCI-CTC標(biāo)準(zhǔn)標(biāo)準(zhǔn)鼓勵(lì)患者在有資質(zhì)的單位參加臨床研究鼓勵(lì)患者在有資質(zhì)的單位參加臨床研究ref：衛(wèi)生部胃癌診療規(guī)范：衛(wèi)生部胃癌診療規(guī)范除特別注明外，卡除特別注明外，卡培他濱可替代靜脈培他濱可替代靜脈輸注輸注5FU!靜脈輸注靜脈輸注5FU優(yōu)于推注優(yōu)于推注全身化療原則全身化療原則有爭議有爭議術(shù)前降期增加R0切除率體內(nèi)藥敏 清除亞臨床病灶改善預(yù)后預(yù)防醫(yī)源性播散優(yōu)點(diǎn)可切除胃癌的新輔助化療可切除胃癌的新輔助化療風(fēng)險(xiǎn)：風(fēng)險(xiǎn)：誘導(dǎo)誘導(dǎo)患者耐藥患者耐藥可手術(shù)切除患者疾病進(jìn)展，失去手術(shù)機(jī)會(huì)可手術(shù)切除患者疾病進(jìn)展，失去手術(shù)機(jī)會(huì)可切除胃癌

25、的輔助治療可切除胃癌的輔助治療手術(shù)切除手術(shù)切除術(shù)后治療術(shù)后治療手術(shù)結(jié)果手術(shù)結(jié)果R0切除切除M1觀察或?qū)τ^察或?qū)Σ糠只颊呓o予化放療部分患者給予化放療（以（以氟尿嘧啶類氟尿嘧啶類為基礎(chǔ)）或者為基礎(chǔ)）或者對(duì)術(shù)前用對(duì)術(shù)前用ECF化療的患者再用化療的患者再用ECF方案（方案（1類）類）姑息治療姑息治療（見（見GAST-5）放療（放療（45-50.4 Gy）+同時(shí)予同時(shí)予 5-FU 為基礎(chǔ)的放療增敏（首為基礎(chǔ)的放療增敏（首選選）+ 5-FU 甲酰四氫葉酸甲酰四氫葉酸R1切除切除R2切切除除Tis或或T1，N0T2，N0T3，T4或或任何任何T，N+觀察觀察放療（放療（45-50.4 Gy）+同時(shí)予同時(shí)予

26、5-FU 為基礎(chǔ)的放為基礎(chǔ)的放療增敏（首選療增敏（首選）+ 5-FU 甲酰四氫葉酸甲酰四氫葉酸 或或卡卡培他濱或培他濱或ECF方案（方案（1類）類）隨訪（見隨訪（見GAST-5）隨訪（見隨訪（見GAST-5）放療（放療（45-50.4 Gy）+ 同時(shí)予同時(shí)予5-FU 為基礎(chǔ)為基礎(chǔ) 的放療增敏的放療增敏 或或化療化療或最佳支持治療（身體狀況差或最佳支持治療（身體狀況差的患者的患者）20102011年中國專家不推薦中國專家不推薦l術(shù)前術(shù)前:順順鉑鉑5FU含卡培他濱方案上升為術(shù)前放化療一類證據(jù)含卡培他濱方案上升為術(shù)前放化療一類證據(jù)DOX和伊利替康進(jìn)入術(shù)前放化療和伊利替康進(jìn)入術(shù)前放化療2Bl術(shù)后術(shù)后:

27、推薦推薦5FULv 在輸注在輸注5FU前后或卡培他濱聯(lián)合放療前后或卡培他濱聯(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 C C NPractice G

28、uidelinesin 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:

29、 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 junction adenocarcinoma, some regimens listed below represent institutional preferen ces andmay not

30、 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 recommending chemotherapy, the requirements for the adequacy of organ function and performance status

31、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 measures to reduce the severity and duration of complications.During chemotherapy, patients should

32、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., and dose modifications.caregivers.c toxicity, doses, schedule()GAST-DReferences on next pageM

33、etastatic 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 2B)Oxaliplatin plus fluoropyrimidine (5-FUor capecitabine) (category 2B)DCF modifications (c

34、ategory 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 ChemotherapyPreoperative ChemoradiationPostoperative Chemoradiation(GE junction adenocarcinoma included):E

35、CF (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 junction adenocarcinoma included)Fluoropyrimidine (5-FU or capecitabine) (category 1)11,234

36、5Leucovorin 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 that is HER-2-positive asdetermined by a standardized method.2010版Version 2.2010, 02/26/10 201

37、0 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 C C NPractice Guidelinesin Oncology v.2.2010Guidelines IndexGastric Cancer Table of ContentsStaging, Discussion

38、, ReferencesGastric 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. Participat

39、ion 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 superior to the category 1 regimens.Please refer to the original reports for specifiPlease r

40、efer 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 thoroug

41、hly 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 closely, treated for any complications, and appropriate blood work should bemonitore

42、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-DReferences on next pageMetastatic or Locally Advanced Cancer(where chemoradiation is not recommended):DCF (Docetaxel, ci

43、splatin and 5-FU) (category 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

44、 regimen (category 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 pacl

45、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)11,2345Leucovorin is indicated with certain infusional 5-FU-based regimens.Used in combination with sy

46、stemic chemotherapy 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 illustra

47、tion may not 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 JUNCTIONADENO

48、CARCINOMA (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 gastroesophag

49、eal 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 Principles of Radiation Therapy for the radiation therapy administration details.Prior to

50、 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 andPatienteducation should also include the discussion of precautions

51、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 completion of chemotherapy, patients should be evaluated for response and any long-term compli

52、cations., 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 5-FU) (category 1)ECF (category 1)ECF modifications (category 1)Irinotecan plus cisplatin

53、 (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)Trastuzumab672,8,910,118,122,13,14,1516,17,18Preoperative and Postoperative Ch

54、emotherapyPreoperative 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 (cat

55、egory 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 chemotherapy for the treatment of patients with advanced gastric cancer or GE junction adenoc

56、arcinoma that is HER-2-positive asdetermined by a standardized method.Which regimen for adjuvant chemotherapy?S1 monotherapy stage II/III gastric cancer patients (Japanese pts) after curative D2 gastrectomy Survival benefit of S1+surgery group over surgery aloneCLASSIC study (international trial) St

57、age II/III, after curative D2 gastrectomy (Korean and Chinese pts ) Capecitabine+oxaliplatin Well tolerated, and significant DFS improvement, survival data is under follow upARTIST study (ongoing) stage Ib (T2bN0) - IV (M1 excluded), after curative D2 gastrectomy Compare XP vs XP + radiotherapy (RT)

58、 Well tolerated, and survival data is under follow upECF or modified ECF after curative resection?FP from FFCD 9703 studyl 輔助化療推薦氟尿嘧啶加鉑類的聯(lián)合方案l 新輔助（術(shù)前）化療推薦ECF及改良方案，術(shù)后根據(jù)術(shù)分期及新輔助療效延續(xù)或酌情調(diào)整方案2011 衛(wèi)生部胃癌診療規(guī)范可手術(shù)胃癌的術(shù)前、術(shù)后化療以聯(lián)合化療為主可手術(shù)胃癌的術(shù)前、術(shù)后化療以聯(lián)合化療為主Total n=1035Total n = 1059Total n = 397Total n = 546Total n =

59、 30420115 6個(gè)月20074q6w, 1年 20063q4w, 6周期 19951q43d, 7周期 1999218個(gè)月DFS HR* 無顯著性差異胃癌輔助化療大宗胃癌輔助化療大宗phaes III 研究的研究的HR1. Mario Lise, et al. JCO; 13(11): 2757-63. 2. T Nakajima, et al. The Lancet; 354: 273-73. D. Nitti et al. Annals of Oncology; 17(2): 262-9. 4. N Engl J Med 357;1810-20; 5. Bang YJ, etc AS

60、CO2011 LBA4002.20年內(nèi)年內(nèi)300例以上對(duì)照單純手術(shù)的胃癌輔助化療研究，例以上對(duì)照單純手術(shù)的胃癌輔助化療研究，DFS/RFS（data base NML） 無顯著差異無顯著差異32442522復(fù)發(fā)風(fēng)險(xiǎn)下降復(fù)發(fā)風(fēng)險(xiǎn)下降XELOX組3年DFS顯著高于觀察組Bang YJ, etc ASCO2011 LBA4002.1.00.00.20.40.60.80DFS36912 15 18 21 24 27 30 33 36 39 42 45 48 513年絕對(duì)差值: 14.0%XELOX (n=520) 74%觀察組 (n=515) 60%HR=0.56 (0.440.72)p0.00013