ASCO胃肠道会议进展张俊

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•268 AS•1C1O0 胃肠•2道8 会议•进0 展张俊•0
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•FOLFOX4
•观察
•随访
•FOLFOX4+ 贝伐单抗
•Bev 5mg/kg q2w
•贝伐单抗单药
•Bev 7.5mg/kg q3w
•XELOX+ •贝伐单抗
•Bev 7.5mg/kg q3w
•贝伐单抗单药
•Bev 7.5mg/kg q3w
•随访 •随访
•24周
•24周
•De GramoAnStCAO,胃et肠a道l. 2会0议11进A展SC张O俊GI Abstract 362.
一线化疗
• Abstract # 365： NORDIC VII （FLOX+西妥昔单抗一线治疗mCRC）
• 打打停停：mCRC标准治疗后以贝伐珠单抗＋卡培他滨维持治疗安全 有效
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ASCO胃肠道会议进展张俊
AVANT：研究设计
•高危II期/III
期结肠癌患者 行手术治疗 •(N=3451)
ASCO胃肠道会议进展 张俊
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2020/10/29
ASCO胃肠道会议进展张俊
Highlights of 2011 ASCO GI 结直肠癌
辅助化疗
• Abstract # 362：AVANT (XELOX+BVZ VS FOLFOX+BVZ VS
FOLFOX alone)
• Abstract # 363： NO147 (FOLFIRIR±西妥昔单抗）
XELOX + Bev (N=952)
1.07 (0.90, 1.28)
•0.0 •0
•Number at risk
•FOLFOX4
•955
•FOLFOX4 + Bev •960
•XELOX + Bev •952
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•6 •12 •18 •24 •30 •36 •42 •48 •54 •60 •66 •72 •Time (months)
Primary endpoints (Stage III patients only): l DFS: FOLFOX4 + bevacizumab vs. FOLFOX4 l DFS: XELOX + bevacizumab •vs. FOLFOX4
Secondary endpoints: l OS l Safety l Non-inferiority of DFS and OS for FOLFOX4 + bevacizumab
223 (23) 47 (5) 21 (2) 30 (3) 62 (7) 57 (6) 64 (7)
177 (19) 46 (5)
•*And
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without
evidence
of
disease
at
randomization;
percentages
bAaSsCeOd胃o肠n道N会议进展张俊
Interim OS (ITT Stage III)
•Event-free rate •1.0 •0.9 •0.8 •0.7 •0.6
•FOLFOX4 •FOLFOX4 + Bev •XELOX + Bev
•0.5 •0.4 •0.3 •0.2 •0.1
HR (95% CI)
FOLFOX (N=955)
vs. XELOX + bevacizumab (if co-primary endpoints met)
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ASCO胃肠道会议进展张俊
DFS (ITT Stage III) Data cut-off date: 30 June 2010 (3-year minimum follow-up)
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ASCO胃肠道会议进展张俊
Site of Recurrence (ITT Stage III)
FOLFOX4 (N=955)
n (%)
FOLFOX4 + Bev (N=960) n (%)
XELOX + Bev (N=952) n (%)
Patients with tumor recurrence* Local recurrence Regional lymph nodes Distant lymph nodes Liver Lung Other
•Event-free rate •1.0 •0.9 •0.8 •0.7 •0.6
•FOLFOX4 •FOLFOX4 + Bev •XELOX + Bev
•0.5 •0.4 •0.3 •0.2 •0.1
HR (95% CI)
FOLFOX (N=955)
FOLFOX4 + Bev (N=960)
1.17 (0.98, 1.39)
1 involved site >1 involved site
219 (23) 39 (4) 19 (2) 36 (4) 82 (9) 45 (5) 62 (6)
164 (17) 55 (6)
252 (26) 42 (4) 22 (2) 31 (3) 87 (9) 63 (7) 88 (9)
192 (20) 60 (6)
FOLFOX4 + Bev (N=960)
AVANT 结果小结
DFS （至少3年随访期） – HR FOLFOX+BVZ 1.17 (0.98, 1.39), (73% 3y DFS) – HR XELOX+BVZ 1.07 (0.9, 1.28), (75% 3y DFS) – 组间无差异 – 1年的DFS HR结果与NSABP-08类似，但1年后消失 – 是否rebound因素？ • 两组的复发部位类似（BVZ组并未更差） • 复发后的生存时间差异不大
研究执行情况和终点指标
l 330 centers, 34 countries, 8 regions (stratified) l 3451 patients randomized between 20 December 2004 and
08 June 2007 - 2867 patients with Stage III disease