Role of cetuximab in first-line treatment of metastatic colorectal cancer

Table 2 Clinical trials of cetuximab in combination with oxaliplatin-based chemotherapy

Clinical trial	Type of study	KRAS analysis	Treatment	Response rate (%)	R0 resection rate (%)	PFS (mo)	OS (mo)
Arnold et al[48]	Phase Ib/II	No	Cetuximab-FUFOX1	57%	4%	8.1	28.2
Tabernero et al[49]	Phase II	No	Cetuximab-FOLFOX4	72%	21%	12.3	30
OPUS, Bokemeyer et al[7,21]	Phase II	Yes	Cetuximab-FOLFOX4 vs FOLFOX4	57% vs 34% (OR = 2.551, P = 0.0027)2	12% vs 3% (P = 0.0242)2	8.3 vs 7.2 (HR = 0.567, P = 0.0064)2	22.8 vs 18.5 (HR = 0.855, P = 0.39)2
COIN, Maughan et al[23]	Phase III	Yes	Cetuximab-mFOLFOX6/XELOX vs mFOLFOX6/XELOX	64% vs 57% (OR = 1.35, P = 0.049)2	15% vs 13 % (P = 0.74)2	8.6 vs 8.6 (HR = 0.96, P = 0.60)2	17 vs 17.9 (HR = 1.04, P = 0.67)2
NORDIC VII, Tveit et al[50]	Phase III	Yes	Cetuximab-Nordic FLOX vs Nordic FLOX3	46% vs 47% (OR = 0.96, P = 0.89)2	13.4% vs 14.4%2	7.9 vs 8.7 (HR = 1.07, P = 0.66)2	20.1 vs 22 (HR = 1.14, P = 0.48)2

¹FUFOX: AIO group weekly regimen of oxaliplatin, folinic acid and infusional 5FU;

²Results in wild-type KRAS population;

³Nordic FLOX: Biweekly regimen of oxaliplatin, bolus 5FU and folinic acid. KRAS: v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog; PFS: Progression-free survival; OS: Overall survival; 5FU: 5-fluorouracil; XELOX: Capecitabine plus oxaliplatin.