胃癌术后临床试验课件

胃癌术后治疗相关临床试验,2012-06-08,主要临床试验,围手术期化疗 MAGIC试验 术后辅助化疗 ACTS-GC；CLASSIC 术后辅助放化疗 INT-0116;ARTIST 转移性或局晚的根治性化疗 SPIRIT；REAL-2；TOGA,NCCN指南,NCCN指南,assigned patients： perioperative chemotherapy and surgery (250 patients) Chemotherapy ：3*ECF preoperative + 3*ECF postoperative ECF ：epirubicin (50 mg/m2)；cisplatin (60 mg/m2) ；fluorouracil (200 mg/m2) for 21 days. surgery alone (253 patients). The primary end point was overall survival. - N Engl J Med. 2006 Jul 6;355(1):11-20.,围手术期化疗-MAGIC试验,围手术期化疗-MAGIC试验,5年生存率 36%vs23%,P=0.0001，HR=0.66; 95%CI：0.530.81,-N Engl J Med. 2006 Jul 6;355(1):11-20.,术后辅助化疗,From January 1998 to December 2007 ；12 RCTs were selected. Included 3809 patients. The HR for os was calculated. The HR for os was 0.78 (95%CI：0.71 to 0.85) in favour of chemotherapy。 Postoperative chemotherapy can improve os ; there is no standardized chemotherapy regimen. Japanese-style D2 radical surgery plus oral 5-fluorouracil appears an effective treatment at present. -Br J Surg. 2009 Jan;96(1):26-33.,术后辅助化疗-ACTS-GC,-N Engl J Med 2007;357:1810-20.,3y os：80.1% vs 70.1%,3y RFS：72.2% vs 59.6%,亚组分析：对II、IIIA病人OS、RFS有统计学意义；对IIIB？,术后辅助化疗-ACTS-GC,术后辅助化疗-CLASSIC,an open-label, parallel-group, phase 3, randomised controlled trial undertaken in 37 centres; stage IIIIIB; curative D2 gastrectomy assigned patients： adjuvant chemotherapy: 8*xelox(capecitabine 1000 mg/m2 bid d 1-14+ oxaliplatin 130 mg/m2 d1,Q3W) for 6 months surgery only. The primary endpoint was 3 year disease-free survival,(520),(515),-The Lancet, Volume 379, Issue 9813,术后辅助化疗-CLASSIC,术后辅助放化疗-INT-0116（SWOG 9008）,OS：36m vs 27m,PFS：30m vs 17m,术后辅助放化疗-INT-0116（SWOG 9008）,This update, presents data on failure patterns、second malignancies 、explores selected subset analyses. Second malignancies were observed in 21 patients with radiotherapy versus eight with observation (P = .21). Subset analyses show robust treatment benefit in most subsets, exception of patients with diffuse histology who exhibited minimal nonsignificant treatment effect -J Clin Oncol. 2012 May 14.,术后辅助放化疗-INT-0116（SWOG 9008）,术后辅助放化疗-ARTIST,primary endpoint :DFS secondary endpoints:overall survival, recurrence rate, toxicity,adjuvant XP：6*XP (capecitabine 1,000 mg/m2 bid d1-14;cisplatin 60 mg/m2 d1 q3w) XP/XRT/XP：2*XP+XRT (45 Gy+ capecitabine 825 mg/m2 bid)+2*XP,lymph nodepositive patients.,3-year DFS 77.5% vs 72.3%;P=0.0365,术后辅助放化疗-ARTIST,DFS according to stage (multivariate analysis).,术后辅助放化疗-ARTIST,NCCN指南,转移性或局晚的根治性化疗-SPIRITS,N=305 advanced GC,R,S-1（150）: 40-60 mg，bid，for 28d，q6w,S-1+D（148）：DDP,60 mg/m2,d8,q5w,The primary endpoint was OS. Secondary endpoints were PFS, safety,S-1+D :13.0 months S-1: 11.0 months,转移性或局晚的根治性化疗-SPIRITS,S-1+D :6.0 months S-1: 4.0 months,转移性或局晚的根治性化疗-SPIRITS,转移性或局晚的根治性化疗-real-2,epirubicin: 50 mg/m2; cisplatin : 60 mg/m2 oxaliplatin:130 mg/m2 Fluorouracil:200 mg/m2 capecitabine: 625 mg/m2 bid Q3W*eight cycles,capecitabine fluorouraci median survival (M) 10.9 9.6 1-year survival rate 44.6% 39.4%,oxaliplatin cisplatin median survival(M) 10.4 10.0 1-year survival rate 43.9% 40.1%,转移性或局晚的根治性化疗-real-2,转移性或局晚的根治性化疗-real-2,转移性或局晚的根治性化疗-TOGA,A phase III study of trastuzumab added to standard chemotherapy (CT) in first-line human epidermal growth factor receptor 2 (HER2)-positive advanced gastric cancer (GC).,Pts(3,807, HER2-positive,22.1%,584) locally advanced, recurrent, metastatic,R,H+CT,CT alone,CT (5-FU /XEL +DDP) ,q3w ,6 cycles,H :given until PD.,The primary end point: OS,median follow-up of pts was 17.1 months,HER2-positivity rate of 22.1% evaluated from 3807 patients. The HER2-positivity rate was similar between Europe (23.6%) and Asia (23.5%). HER2-positivity rates were higher