• 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.
胃癌术后治疗相关临床试验
1
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
4
围手术期化疗-MAGIC试验
5年生存率 36%vs23%
---N Engl J Med. 2006 Jul 6;355(1):11-206.
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.
10
术后辅助化疗--CLASSIC
(520) (515)
-----The Lancet, Volume 379, Issue 9813,
11
术后辅助放化疗--INT-0116（SWOG 9008）
12
术后辅助放化疗--INT-0116（SWOG 9008）
OS：36m vs 27m
PFS：30m vs 17m
• Subset analyses show robust treatment benefit in most subsets, exception of patients with diffuse histology who exhibited minimal nonsignificant treatment effect
13
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).
DFS according to stage (multivariate analysis).
17
NCCN指南
•
-Br J Surg. 2009 Jan;96(1):26-733.
术后辅助化疗--ACTS-GC
8
----N Engl J Med 2007;357:1810-20.
术后辅助化疗--ACTS-GC
3y os：80.1% vs 70.1%
3y RFS：72.2% vs 59.6%
9
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--CLASSIC
• an open-label, parallel-group, phase 3, randomised controlled trial undertaken in 37 centres;
• stage II—IIIB; curative D2 gastrectomy • assigned patients：
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XP/XRT/XP：2*XP+XRT (45 Gy+ capecitabine 825 mg/m2 bid)+2*XP
术后辅助放化疗--ARTIST
3-year DFS 77.5% vs 72.3%;P=0.0365
lymph node–positive patients.
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术后辅助放化疗--ARTIST
•
---J Clin Oncol. 2012 May 14.
14
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)
→surgery alone (253 patients).
• The primary end point was overall survival.
--- N Engl J Med. 2006 Jul 6;355(1):11-20.
5
围手术期化疗-MAGIC试验
P=0.0001，HR=0.66; 95%CI：0.53～0.81
• → 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