TABLE 3.

Pivotal adjuvant CC clinical trials

Author Trial Name^a	Journal	Regimen Tested	Number of Patients	Stage	Primary Endpoint^b	Significance
OXALIPLATIN TRIALS
Kuebler et al⁷⁵ NSABP- C-07	JCO, 2007	FLOX vs 5FULV	1207 vs 1200	II – 28.9% III-70.9% vs II-28.8% III-70.5%	4 yr DFS 73.2% vs 67% 4 yr OS 78.5% vs 76%	p<0.0034
Andre et al^74,76 MOSAIC	JCO, 2009	FOLFOX4 vs LV5FU2	1108 vs 1111	II - 40.2% III-59.8% vs II-39.9% III-60.1%	6 yr DFS 73.3% vs 67.4% 6 yr OS 78.5% vs 76%	p<0.003
Haller et al XELOXA NO16968	GI ASCO, 2010 Abstr. 284	CapeOx vs 5FULV	N= 1886	III only	5 yr DFS 66.1% vs 59.8% OS Not reported	p<0.0045
RINOTECAN TRIALS
Saltz et al⁷⁸ CALGB 89803	JCO, 2007	IFL vs 5FULV	635 vs 629	III only	5 yr OS 68% vs 71%	p=0.85 NS
Van Cutsem et al⁸⁰ PETACC-3	JCO, 2009	FOLFIRI vs LV5FU2	1485 vs 1497	II – 29.3% III-70.3% vs II-29.7% III-70%	5 yr DFS 56.7% vs 54.3% 5 yr OS 73.6% vs 71.3% NS	p=0.106 NS
Ychou et al⁷⁹ ACCORD-2	Ann Oncol, 2009	FOLFIRI vs LV5FU2	161 vs 160	Resected IV	DFS 24.7 vs 21.6 3 yr OS 73% vs 72% NS	p=0.44 NS
CAPECITABINE
Twelves et al⁸¹ X-ACT	NEJM, 2005	Cape vs 5FULV	1004 vs 983	III only	3 yr DFS non-inferiority 64.2% vs 60.6% 3 yr OS 81.3% vs 77.6% NS	Superiority p=0.12 NS Equivalence p<001
Haller et al XELOXA NO16968	GI ASCO, 2010 Abstr. 284	CapeOx vs 5FULV	N= 1886	III only	5 yr DFS 66.1% vs 59.8% OS Not reported	p<0.0045
ANTI-ANGIOGENESIS: BEVACIZUMAB
Wolmark et al NSABP C-08	ASCO, 2009 Abstr. LBA4	FOLFOX6 + bev vs FOLFOX6	1334 vs 1338	II – 24.9% III –75.1%	3 yr DFS 77.4% vs 75.5%	p=0.15 NS
AVANT	Ongoing	FOLFOX4 + bev or XELOX + bev vs FOLFOX4	1150 vs 1150	High risk II + III	DFS
ANTI-EGFR: CETUXIMAB
Alberts et al N0147	ASCO, 2010 Abstr. CRA- 3507	FOLFOX6 + cetuximab vs FOLFOX6	902 vs 858	III only KRAS wt only	3 yr DFS 74.1% vs 73.3% 3 yr OS 87.3% vs 82.1% NS	p=0.33 NS
PETACC-8	Ongoing	FOLFOX+ cetuximab vs FOLFOX	N= >6000	III only KRAS wt only	3 yr DFS	First interim analysis planned 2011

Randomized Phase III trials unless otherwise specified.

Units indicated in months unless otherwise indicated.

DFS, disease free survival; OS, overall survival; Cape, capecitabine; NS, not significant; Bev, bevacizumab; wt, wild type.