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

Table 3 Clinical trials of neoadjuvant cetuximab in the treatment of liver metastases

Clinical trial	Type of study	KRAS analysis	Treatment	Response rate	R0 resection rate	PFS (mo)	OS (mo)
CELIM, Folprecht et al[67,68]	Phase II	Yes	Cetuximab-FOLFOX6 vs cetuximab-FOLFIRI	68% vs 57% (OR = 1.62, P = 0.23)	38% vs 30%	11.2 vs 10.5 (HR = 1.15, NS)	35.7 vs 29.0 (HR = 1.09, NS)
			Wild-type KRAS vs mutated KRAS	70% vs 41% (OR = 3.42, P = 0.008)	33% vs 30%	11.9 vs 9.9 (HR = 1.31, NS)	36.1 vs 27.4 (HR = 1.48, NS)
Ye et al[70]	Phase IV	Yes	Cetuximab-mFOLFOX6/FOLFIRI vs mFOLFOX6/FOLFIRI	57.1% vs 29.4% (P < 0.01)	25.7% vs 7.4% (P < 0.01)	10.2 vs 5.8 (HR = 0.6, P = 0.004)	30.9 vs 21 (HR = 0.54, P = 0.013)
			Cetuximab-mFOLFOX6 vs Cetuximab-FOLFIRI	52.8% vs 59.1% (P = 0.31)		10.1 vs 9.1 (P = 0.28)	34.8 vs 23.1 (P = 0.24)
POCHER, Garufi et al[73]	Phase II	Yes	Cetuximab-Chrono-IFLO1	79.1	60	14	37
Saridaki et al[75]	Phase II	Yes	Cetuximab-FOLFIRINOX	70	372 623	10.2	30.3

¹Chronomodulated infusion of irinotecan, 5FU, leucovorin and oxaliplatin;

²R0 resection rate in overall population;

³R0 resection rate in the subgroup of patients with metastatic disease limited to the liver. KRAS: v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog; PFS: Progression-free survival; OS: Overall survival; NS: Not significant; 5FU: 5-fluorouracil; FOLFIRI: Regimen of irinotecan, infusional fluorouracil and leucovorin.