2018年nccn胃癌臨床實(shí)踐指南中國版解讀

1、Copyright ©2005 American Cancer Society,Age-standardized Incidence Rates for Stomach Cancer in world.,From Parkin, D. M. et al. CA Cancer J Clin 2005;55:74-108.,,世界胃癌年齡調(diào)整發(fā)病率,對(duì)1990-1992年中國的1/10萬人口死因抽樣調(diào)查資料中胃癌死亡情況進(jìn)行分析

2、,胃癌粗死亡率(crude mortality rate) 25.2/10 萬（M：32.8/10 萬，F(xiàn)：17.0/10 萬），占全部惡性腫瘤死亡的23.2%，惡性腫瘤死亡中第一位。（男性是女性1.9倍）中國胃癌世界人口調(diào)整死亡率(mortality rates adjusted by the world population)男性：40.8/10 萬，女性：18.6/10 萬，分別是歐美發(fā)達(dá)國家的4.2-7.9 倍，3.8-8.

3、0 倍有明顯的地區(qū)差異和城鄉(xiāng)差別。全國抽樣調(diào)查263個(gè)點(diǎn)，胃癌調(diào)整死亡率在2.5-153.0 /10萬之間，Urban areas:15.3/10 萬; Rural areas:24.4/10萬，是城市的1.6 倍,NCCN共識(shí)分類,1類：基于高水平的證據(jù)，NCCN達(dá)成共識(shí)，推薦應(yīng)用2A類：基于包括臨床經(jīng)驗(yàn)在內(nèi)的稍低水平證據(jù)，NCCN達(dá)成共識(shí)，推薦應(yīng)用。2B類：基于包括臨床經(jīng)驗(yàn)在內(nèi)的稍低水平證據(jù)，NCCN未達(dá)成統(tǒng)一共識(shí)（但無較大

4、分歧）。3類：NCCN對(duì)該建議的適宜性存在較大分歧。除非特別說明，本指南中所有的建議均達(dá)成2A類共識(shí)。,NCCN 胃癌臨床實(shí)踐指南 2008第1版指南更新主要變化總結(jié),（GAST-1）：workup：PET/CT掃描和EUS作為可選的檢查項(xiàng)目。（GAST－ 2）： 要求

5、多學(xué)科會(huì)議討論患者所有三個(gè)治療途徑的抉擇 T2以上分期患者將術(shù)前化療作為一類推薦首選治療手段。術(shù)前放化療作為2B類的首選治療手段。（GAST－3）： R0術(shù)后分期T2 N0M0及以上者，如術(shù)前采用ECF方案化療，術(shù)后可選擇ECF繼續(xù)（1類）（GAST－5）： follow up：近端胃大部或全胃切除者，應(yīng)監(jiān)測并補(bǔ)充Vit B12（GAST－A）：增加綜合治療模式原則新頁（GAST－B、C）： 更新外科及系統(tǒng)化療原則（

6、GAST－A）： 新增放療原則新頁,NCCN guidelines ----Gastric Cancer Chinese version 1. 2008,在整個(gè)治療指南中將chemotherapy/RT 更改為 chemoradiation將salvage 改為palliative,與2007版類似,注意： 除了特別指出的情況，所有推薦的治療都是2A證據(jù)的。 臨床試驗(yàn)：NCCN認(rèn)為對(duì)于任何一個(gè)腫瘤病人參加臨床實(shí)驗(yàn)都

7、獲得最佳治療. 要特別鼓勵(lì)參與臨床試驗(yàn)。,,,強(qiáng)調(diào)多學(xué)科評(píng)估和協(xié)作！,多學(xué)科綜合治療模式有益于局部進(jìn)展期胃癌患者（1類證據(jù)）NCCN專家組基本觀點(diǎn)：不鼓勵(lì)單一學(xué)科成員單方面進(jìn)行治療決策。具備以下條件，可能給局部進(jìn)展期胃癌患者以最佳的綜合治療：例會(huì)形勢實(shí)用（一周或2周一次），相關(guān)學(xué)科的機(jī)構(gòu)和個(gè)人定期來共同回顧患者的詳細(xì)資料。每次例會(huì)，各相關(guān)學(xué)科都要積極參與，包括腫瘤外科，腫瘤內(nèi)科，消化科，放射科，病理科。 此外，最好還能包括營養(yǎng)科

8、，社工，護(hù)理以及其他支持學(xué)科。所有長期的治療策略要在全面分期檢查完成后再進(jìn)行，最好在所有治療開始之前。決策前共同回顧原始的醫(yī)學(xué)數(shù)據(jù)而非單純閱讀報(bào)告。多學(xué)科團(tuán)隊(duì)做出共識(shí)推薦并摘要記錄在案，對(duì)每位患者是有益的。特定患者的主要治療小組或醫(yī)生應(yīng)尊重以及考慮多學(xué)科團(tuán)隊(duì)所做出的共識(shí)推薦。反饋部分患者的治療隨訪結(jié)果，對(duì)整個(gè)多學(xué)科團(tuán)隊(duì)是有效的實(shí)例教育方式。在例會(huì)期間，正式的定期復(fù)習(xí)相關(guān)文獻(xiàn)，對(duì)整個(gè)多學(xué)科團(tuán)隊(duì)是高效的教育方式。,,分期CT掃描

9、±EUS判斷病灶范圍腹腔鏡有助于部分患者的分期不能根治性切除標(biāo)準(zhǔn)局部進(jìn)展期:3/4站淋巴結(jié)轉(zhuǎn)移, 大血管受侵或被包繞遠(yuǎn)處轉(zhuǎn)移或腹膜種植(包括腹腔脫落細(xì)胞學(xué)陽性可切除腫瘤T1者在有經(jīng)驗(yàn)者可采用內(nèi)鏡下胃粘膜切除T1-T3合適的腫瘤切緣≥4 cm（5 cm）, 鏡下陰性推薦D1/D2淋巴結(jié)清掃, 應(yīng)至少檢查15個(gè)淋巴結(jié)，并結(jié)合位置清掃到2站淋巴結(jié) T4應(yīng)切除受累部位不做常規(guī)脾切除, 除非脾臟受累或脾門受侵可考

10、慮留置空腸營養(yǎng)管姑息手術(shù)可以接受切緣陽性，淋巴結(jié)不強(qiáng)求清掃胃腸短路或營養(yǎng)管,外科治療原則,NCCN v.1.2008 Gastric Cancer,結(jié)合淋巴結(jié)數(shù)目以及累及區(qū)域分期,Japanese Gastric cancer associati（JGCA),,腹腔細(xì)胞學(xué)（CY）CY0 腹腔細(xì)胞

11、學(xué)良性或無法確定CY1 腹腔細(xì)胞學(xué)未見癌細(xì)胞CYx 未作其它遠(yuǎn)處轉(zhuǎn)移（M）§M0 腹膜、肝、腹腔細(xì)胞學(xué)外無遠(yuǎn)處轉(zhuǎn)移M1 腹膜、肝、腹腔細(xì)胞學(xué)外有遠(yuǎn)處轉(zhuǎn)移Mx 不清楚 分期,表2 日本胃癌學(xué)會(huì)（JGCA）分期（1998年第13版*）原發(fā)腫瘤（T）T1 腫瘤侵犯粘膜層和/或粘膜肌層(M)和/或粘膜下層(SM)T2 腫瘤侵犯固有肌層(MP)或漿膜下層(SS) ?T3 腫瘤穿透漿膜(

12、SE) ?T4 腫瘤侵犯鄰近結(jié)構(gòu)(SI) ?Nx 不明局部淋巴結(jié)（N）淋巴結(jié)分站分組（見ST-3）淋巴結(jié)轉(zhuǎn)移程度N0 無淋巴結(jié)轉(zhuǎn)移證據(jù)N1 第一站淋巴結(jié)有轉(zhuǎn)移，第二、三站淋巴結(jié)無轉(zhuǎn)移N2 第二站淋巴結(jié)有轉(zhuǎn)移，第三站淋巴結(jié)無轉(zhuǎn)移N3 第三站淋巴結(jié)有轉(zhuǎn)移Nx 區(qū)域淋巴結(jié)無法評(píng)估肝轉(zhuǎn)移（H）H0 無肝轉(zhuǎn)移H1 有肝轉(zhuǎn)移Hx 不清楚腹膜轉(zhuǎn)移（P）P0 無腹膜轉(zhuǎn)移P1 有腹膜轉(zhuǎn)移,*

13、本分期源自 Japanese Gastric Cancer Association. Japanese Classification of Gastric Carcinoma - 2nd English Edition. Gastric Cancer (1998) 1: 10–24?腫瘤可以穿透固有肌層達(dá)胃結(jié)腸韌帶或肝胃韌帶或大小網(wǎng)膜，但沒有穿透這些結(jié)構(gòu)的臟層腹膜。在這種情況下，原發(fā)腫瘤的分期為T2。如果穿透覆蓋胃韌帶或網(wǎng)膜的臟層腹膜

14、，則應(yīng)當(dāng)被分為T3期。?腫瘤侵犯大、小網(wǎng)膜、食管和十二指腸不作為T4,經(jīng)胃壁內(nèi)擴(kuò)展至十二指腸或食管的腫瘤分期取決于包括胃在內(nèi)的這些部位的最大浸潤深度。§M1的種類應(yīng)注明：LYM: 淋巴結(jié)；PLE: 胸膜；MAR: 骨髓；OSS: 骨；BRA:腦；MEN: 腦膜；SKI: 皮膚；OTH: 其它,,Regional LN Group According to Location of Tumor,LD/L,Sasako et a

15、l : the long-term outcome of survival ：D2 vs D2+, no statistically significant difference69% vs 70%, p=0.57, HR:1.03, ( 95% CI: 0.77-1.37). Sasako M, Sano T, Yamamoto S, et al. Randomized phas

16、e III trial of standard D2 versus D2 + para-aortic lymph node (PAN) dissection (D) for clinically M0 advanced gastric cancer: JCOG9501. J Clin Oncol 2006.24(18S):LBA4015.,擴(kuò)大根治 or D2 ? ——循證醫(yī)學(xué)證據(jù),A prospective randomized

17、 controlled clinical trialin Taiwan : D2 vs D1 5-year survival D2 dissection was superior to D1 dissection 59.5% vs 53.6%, p=0.041; HR: 0.49, p=0.002 Wu CW, Hsiung CA, Lo SS, et al. Nodal dissectio

18、n for patients with gastric cancer: A randomized controlled trial. Lancet Oncol 2006;7:309-315進(jìn)一步的臨床試驗(yàn)，特別是觀察手術(shù)前后的輔助治療應(yīng)該基于D2式手術(shù)！,D1 or D2 ? ——循證醫(yī)學(xué)證據(jù),適合于所有胃癌胃切除標(biāo)本原發(fā)性胃癌胃切除標(biāo)本的檢查原發(fā)性腫瘤*外科切緣評(píng)估?淋巴結(jié)評(píng)估?原發(fā)性胃癌的組織學(xué)類型§

19、Lauren分類，1965日本胃癌研究協(xié)會(huì)（JRSGC）分類，1981WHO分類，2000病理學(xué)分期（pTNM）應(yīng)包括下列參數(shù)：腫瘤的惡性程度（分級(jí)）ξ浸潤的深度淋巴結(jié)的部位、數(shù)目及陽性數(shù)遠(yuǎn)端及近端外科切緣狀況,注釋胃癌原發(fā)腫瘤檢查應(yīng)包括：腫瘤在胃粘膜確切位置及腫瘤范圍；腫瘤距近端和遠(yuǎn)端外科切緣的距離；腫瘤大體形態(tài)，包括腫瘤大小、早期胃癌的形態(tài)類型；腫瘤切面，浸潤胃壁情況。? 外科切緣評(píng)估：胃切除標(biāo)本有遠(yuǎn)端及近端切緣

20、：部分切除標(biāo)本，遠(yuǎn)端切緣是十二指腸，近端切緣是胃體；全胃切除標(biāo)本，遠(yuǎn)端切緣是十二指腸，近端切緣是食管。外科切緣有3種情況：R0：外科切緣干凈；R1：外科切緣鏡下陽性；R2：外科切緣肉眼陽性。建議切除的近端切緣應(yīng)距腫瘤邊緣5cm，同時(shí)應(yīng)常規(guī)術(shù)中切緣冰凍檢查。? 淋巴結(jié)評(píng)估：見ST-1/2/3。根據(jù)胃切除時(shí)淋巴結(jié)清掃的范圍分為：D0：淋巴結(jié)清掃的范圍不包括所有N1淋巴結(jié)；D1：淋巴結(jié)清掃的范圍不包括所有N2淋巴結(jié)；D2：淋巴結(jié)清掃的范

21、圍不包括所有N3淋巴結(jié)。按照AJCC標(biāo)準(zhǔn)，因?yàn)楸粰z查淋巴結(jié)的數(shù)量和淋巴結(jié)陽性率之間有正相關(guān)，應(yīng)檢查至少15個(gè)淋巴結(jié)。,§ 胃癌組織學(xué)類型Lanren分類（1965）：腸型；彌漫型JRSGC分類（1981）： 乳頭狀型 管狀型 低分化型 粘液型 印戒細(xì)胞型WHO分類（2000） 腺癌 腸型 彌漫型 乳頭狀腺癌 管狀腺癌 粘液腺癌 印戒細(xì)胞

22、癌 腺鱗癌 鱗狀細(xì)胞癌 小細(xì)胞癌 未分化癌 其它ξ 胃腺癌組織學(xué)分級(jí)：高分化；中分化；低分化；未分化病理學(xué)分期（pTNM） 病理學(xué)分期與胃癌預(yù)后極其相關(guān)，早期胃癌預(yù)后極好，5年生存率達(dá)90%。建議使用AJCC/UICC分類，在病理報(bào)告中N分期可增加標(biāo)注JRSGC要求的淋巴結(jié)部位。,病理診斷原則,系統(tǒng)化療原則 NEW,遵照原始文獻(xiàn)報(bào)道的藥物劑量/方案, 合理用藥并進(jìn)行適當(dāng)調(diào)整患者合適的器官功能和

23、體力狀況充分考慮化療的毒性和益處, 并始終與患者及家屬討論/交流, 并進(jìn)行患者教育, 警示并防治不良反應(yīng), 避免嚴(yán)重合并癥及縮短持續(xù)時(shí)間患者化療期間仔細(xì)觀察, 及時(shí)治療合并癥, 并適當(dāng)監(jiān)測患者血液學(xué)改變化療階段及時(shí)評(píng)估療效和長期合并癥,Update of 2008.v.1 NCCN version,可切除胃癌圍手術(shù)期化療---MAGIC trial,胃癌（占85%）或低位食管癌（15%）,ECF* 3cs-手術(shù)-ECF

24、3cs,單一手術(shù),N=2505Y 38%,N=2535Y 23%,ECF:E 50mg/m2C 60mg/m2FU 200mg/m2/d civ,D.Cuuningham 2005 ASCO abs 4001,Cunningham et al, NEJM 2006,*No pathologic complete responses,可切除胃癌圍手術(shù)期化療---MAGIC trial,Cunningham et al, N

25、EJM 2006,Cunningham et al, NEJM 2006,可切除胃癌圍手術(shù)期化療---MAGIC trial,Overall Survival,可切除胃癌圍手術(shù)期化療 5-FU+DDP in AGC/LE ---FFCD 9703 trial,,FP 2～3cs（98例）-手術(shù)-FP 2～ 3cs (RR+SD n+)（54例）,單一手術(shù),N=1135Y DFS 34%,N=1115Y DFS 21%,

26、FP:5-FU 800mg/m2 d1-5 ciDDP 100mg/m2 d1Q4w隨訪 5.7Y,賁門、胃89％食管11％,可切除胃癌圍手術(shù)期化療 5-FU+DDP in AGC/LE ---FFCD 9703 trial,HR 0.65,V. Boige et al, ASCO 2007 abstr 4510,可切除胃癌圍手術(shù)期化療Patient data-based meta-analysis: CT

27、+S vs S,從12隨機(jī)試驗(yàn), 2284 患者中篩選出2102患者,涉及9個(gè)試驗(yàn), 中位隨訪時(shí)間5.3年CT+S vs S HR 0.87 P=0.003 轉(zhuǎn)化為5年絕對(duì)生存率提高4%R0切除率 67% vs 62% p=0.03,P.G.Thirion et al, ASCO 2007 abstr 4512,GAST-C 1 of 2: preoperative chemoradiation,2008.v.1NCCN

28、 guideline： Paclitaxel/docetaxel + fluoropyrimidine(5-FU or capecitabine) category 2B；Recommendation of Chinese version: Docetaxel might be changed; Category 2B to 3.,Reason:Study about Paclitaxel/5F

29、U+RT is only phase II.No prospective studies has been searched on docetaxel/5-FU +RT(medline).,？,Preoperative chemoradiation: phase IIPhase II Trial of Preoperative Chemoradiation in Patients With Localized Gastric Ade

30、nocarcinoma (RTOG 9904): Quality of Combined Modality Therapy and Pathologic Response——Jaffer A. Ajani JCO 2006：24（24）：3593,Phase: IIPatients： 43 cases with localized GC (12% IB; 37% II; 52% III).，20 center Meth

31、ods: 2cys of 5FU+CF+DDP——CRT (infusional 5FU+weekly paclitaxel) Resection （5 to 6 weeks after chemoradiotherapy was completed.）Result： path CR： 26% R0 resection ：77%, 1 year：more patients with path CR

32、 (82%) are living than those with less than path CR (69%）,GAST-C 1 of 2: preoperative chemoradiation,2008.v.1NCCN guideline： Paclitaxel/docetaxel + fluoropyrimidine(5-FU+capecitabine) category 2B；Recommendat

33、ion of Chinese version: Docetaxel might be changed; Category 2B to 3.,Update of 2008.v.1 NCCN version,Postoperative chemotherapy?,,Stage IB-IV(M0)D0 和 D1占90%,,GAST-3:T3,T4 or any T,N1 after R0 resection,2008.

34、v.1NCCN guideline：RT,45-50.4Gy+concurrent 5-FU based radiosensitization(preferred)+5-FU±leucovorin or ECF if received preoperatively（category 1）Recommendation of Chinese version: Add foot noteIf D0/D1 resection: a

35、greed the above;If D2 resection: postoperative chemotherapy recommended.,Evidence：D0/D1 operation consists more than 90% in INT0116；2 Meta analysis about adjuvant chemotherapyGASC-study,Patients: 23 trials， 4919 pts

36、Methods: Adjuvant chemotherapy arm(Arm A): 2441 Observation arm(Arm B): 2478 Results: 3y Survival rate: 60.6% in Arm A, 53.4% in Arm B

37、 (RR: 0.85,95%CI: 0.80–0.90 ) DFS: Arm B had a shorter DFS (RR: 0.88, 95%CI: 0.77–0.99) Recurrence rate: Arm A had a lower recurre

38、nce rate (RR: 0.78, 95%CI: 0.710.86) Grade 3/4 of AE(myelosuppression and GI): more frequently in Arm A. Conclusion: Adjuv

39、ant chemotherapy could improve the survival rate and disease-free survival rate in gastric cancer after curative resection and reduce the relapse rate.,META analysis of Adjuvant chemotherapy 1An updated meta-analysis of

40、 adjuvant chemotherapy after curative resection for gastric cancer——European Journal of Surgical Oncology (EJSO) 2008.02.002,META analysis of Adjuvant chemotherapy 2The role of postoperative adjuvant chemotherapy follo

41、wing curative resection for gastric cancer: a meta-analysisShu-Liang Zhao; Jing-Yuan Fang. Renji Hospital, Shanghai, China.Cancer Investigation, May2008, Vol. 26 Issue 3, p317-325,,Patients: 15 trials， 3212 pts，Meth

42、ods: Surgery+adjuvant chemotherapy vs Surgery onlyResults: RR for death in the treated group was 0.90 (P = 0.0010). Little or no significant benefits were suggested in subgroup analyses between different

43、population and regimens either. Conclusion: Postoperative adjuvant chemotherapy for gastric cancer confers slightly significant benefits compared to the surgery only group.,Postoperative adjuvant chemotherapy ——S1

44、 monotherapyAdjuvant chemotherapy for gastric cancer with S-1, an oral fluoropyrimidine.—— Sakuramoto, S N Engl J Med，2007，357：1810-1820,1004 cases(stage II/III ，D2,,3 years follow up*,,Randomized phase III trial com

45、paring S-1 monotherapy versus surgery alone for stage II/III gastric cancer patients (pts) after curative D2 gastrectomy (ACTS-GC study). 2007Gastrointestinal cancer symposium, sasako M,,,,,,*12/2005 showed that HR of de

46、ath for S-1 to C was 0.57, trial was recommended to stop. 09/2006 HR of death for S-1 was 0.68.,,Conclusions: Adjuvant chemotherapy with S-1 for gastric cancer is feasible and effective. This regimen can be the stan

47、dard treatment for stage II/III gastric cancer pts after curative D2 dissection.,ACTS-GC study JCOG,Postoperative chemoradiation might be a good option to compensate the insufficiency of the surgery such as D0/D1 resec

48、tion.Adjuvant chemotherapy shows survival benefit compared with surgery alone, especially after D2 resection for patients with stage II or higher.,Postoperative adjuvant chemotherapy Conclusion:,GAST-3：after R1 resectio

49、n,2008.v.1NCCN guideline：RT,45-50.4Gy+concurrent 5-FU-based radiosensitization (preferred) +5-FU±leucovorinRecommendation of Chinese version: To add “Clinical trials” as another option.,Reason：R1 resection

50、 is not radical, till now, no standard therapy has been accepted, it should be better to find the appropriate ones by clinical studies.,Update of 2008.v.1 NCCN version,No DDP+fluoropyrimidine (5-FU or capecitabine or S－

51、1 ) 2BNo paclitaxel-based regimens；,V325 研究結(jié)果,TCF(多西紫杉醇、順鉑、5FU)是用于預(yù)后較好的患者的一項(xiàng)新的治療選擇,Moiseyenko et al, JCO 2007,,*3－4級(jí)毒性包括：81％的非血液學(xué)毒性反應(yīng)，75％的血液學(xué)毒性反應(yīng)中30％伴有中性粒細(xì)胞減少性發(fā)熱,CPT-11 for AGC——Ⅱ期多中心臨床研究（2003 ASCO）FFCD 9803 法國,B

52、ouche O et al. J Clin Oncol2004;22:4319–27,CPT-11聯(lián)合5-FU治療AGC----III期臨床試驗(yàn)（2005 ASCO）,N=170CPT-11 80mg/m2CF 500mg/m25FU 2000mg/m2 civ1/W x 6w,N=163CDDP 100mg/m2 d15FU 1000mg/m2/d d1-5Q4W,N=333 AGC,RR 54

53、（31.8%） 42（25.8%）TTP 5.0m 4.2m (p=0.088)TTF 4.0m 3.4m (p=0.002)OS 9.0m

54、 8.7m p＝0.53,M. Dank 2005 ASCO abs 4003,,,REAL-2: 療效（Efficacy）,Cunningham et al. ASCO 2006 LBA 4017,,,REAL 2: 安全性 safety outcomes,Oxaliplatin聯(lián)合EPI、5-FU/CF治療晚期胃癌的臨床多中心研究—— china,用藥方法樂沙定

55、 100mg/m2 d1EPI 50mg/m2 d1CF 200mg/m2 d1-35-FU 500mg/m2 CIV d1-3每3周重復(fù)，治療至少3個(gè)周期評(píng)價(jià)療效及毒性反應(yīng),,CR 2例（5.6%）PR 13例（36.1%）SD 17例（47.2%） 總有效率41.7%。其中初治患者9/20（45%）復(fù)治患者6/16（37.5%）],,主要不良反應(yīng)：骨

56、髓抑制： Ⅲ-ⅣOANC7/36（19.4%）， ⅢOPLT3/36（8.3%），ⅢO Hb4/36（11.1%），ⅢO神經(jīng)末梢毒性 4/36（11.1%），,以EPI為基礎(chǔ)的三藥聯(lián)合可行！EOX有明顯生存優(yōu)勢！,,,ML17032 : CAPE vs 5-FU in AGCtrial design,,FPCisplatin80 mg/m2 3-hour i.v. infusion5-FU c.i. 800 mg/m2/da

57、y; d1–5 q3w,XPCisplatin80 mg/m2 3-hour i.v. infusionCapecitabine 1000 mg/m2 twice daily; d1–14 q3w,KPS ≥70%18–75 yearsAdvanced and/ormetastatic gastric cancer (AGC)≥1 measurable lesionNo prior treatment for AGC,

58、RANDO MIZATION,,,,,,Superior response rate with XP vs. FP,ML17032 : XP vs FPprogression-free survival.HR 0.81,Estimated probability,HR=0.81 (95% CI: 0.63–1.04)Compared to HR upper limit 1.25, p=0.0008,,,1.0,

59、0.8,0.6,0.4,0.2,0.0,Per protocol analysis,相似的血液學(xué)不良發(fā)應(yīng) XP vs. FP,A Phase II Trial of Capecitabine plus DDP in AGC－－China,2002.6-2003.5, N=145, Cape 1000mg/m2 Bid d1-14 DDP 20mg/m2 iv d1-5

60、 q3W130pts evaluable : 98M/32F Age: 53.7ys,Results,CR 10 (8%)PR 48(37%)SD 51(39%)PD 21(16%)OS 12m,,Safety：grade 3-4 adverse event < 5%,-----2005,2006 ASCO,,,first-line c

61、hemotherapy with fluorouracil, leucovorin and oxaliplatin (FLO) versus fluorouracil, leucovorin and cisplatin (FLP),,FLOF 2600mg/m2 24h infusion, L 200mg/m2, oxaliplatin 85mg/m2 q2w,FLPF 2000mg/m2 24h infusion, qwL

62、200mg/m2, qw cisplatin 50mg/m2, q2w.,Total 220 pts Median age 64 yrs Advanced and/ormetastatic gastric cancer (AGC),RANDO MIZATION,,,,,S. Al-Batran, J. Hartmann, ASCO 2006,The primary end point was TTP,Sup

63、erior Performance with FLO vs. FLP,S. Al-Batran, J. Hartmann, ASCO 2006,Phase II Study of S-1 ±DDP vs 5-FU+DDP for Gastric Cancer (PI:ML Jin),C:5-FU+DDP,A:S-1,B:S-1+DDP,,,,randomization,Assumed 180 cases，60 cases pe

64、r arm，enrollment completedObjective：RR, TTP,Pathologically confirmed，unrectable，measurable leasions,,Evidence ：SC-101 study —— 2008 ASCO meeting,,,※: Arm B compared with Arm C ,

65、 P<0.05★: Arm B compared with Arm A and C , P<0.05＃: Arm B compared with Arm A and C , P<0.05,* : Arm B compared with Arm A , P>0.05,Evidence ：SC-101 study —— 20

66、08 ASCO meeting,Elderly chemo-naïve pts (>= 65 years) with measurable metastatic or recurrent gastric cancer,armX (N=46, Median age=71.0 years )Capecitabine (1,250 mg/m2 bid, D1-14 every 3 weeks),arm S (N=4

67、5, Median age= 70.5 years )S-1(40~60 mg bid D1-28 every 6 weeks),randomly,,,10/2004-4/2006,A randomized multi-center phase II trial：capecitabine (X) versus S-1 (S) as first-line treatment in elderly patients

68、with mAGC,Y. Kang, D. Shin 2007 ASCO Annual Meeting,,A randomized study: the activity and safety of capecitabine vs S-1 in elderly pts with AGC phase II Y. Kang, JCO, 2007 ASCO Meetings Proceedings Part I.Vol 25, No.