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

Table 1 Clinical trials of cetuximab in combination with irinotecan-based chemotherapy

Clinical trial	Type of study	KRAS analysis	Treatment	Response rate	R0 resection rate	PFS (mo)	OS (mo)
Folprecht et al[37]	Phase I/II	No	Cetuximab-Irinotecan/5FU/FA1	67%	19%	9.9	33
Raoul et al[38]	Phase I/II	No	Cetuximab-FOLFIRI	48%	19.20%	8.6	22.4
CRYSTAL, Van Cutsem et al[6,20]	Phase III	Yes	Cetuximab-FOLFIRI vs FOLFIRI	57.3% vs 39.7% (OR = 2.069, P < 0.001)2	5.1% vs 2% (OR = 2.65, P = 0.0265)2	9.9 vs 8.4 (HR = 0.696, P = 0.0012)2	23.5 vs 20 (HR = 0.796, P = 0.0093)2
FIRE-3, Heinemann et al[41]	Phase III	Yes	Cetuximab-FOLFIRI vs Bevacizumab-FOLFIRI	62 vs 57 (OR = 1.18, P = 0.183)		10 vs 10.3 (HR = 1.06, P = 0.547)	28.7 vs 25 (HR = 0.77, P = 0.017)

¹AIO group regimen of irinotecan, folinic acid and infusional 5FU;

²Results in wild-type KRAS population. PFS: Progression-free survival; OS: Overall survival; FA: Folinic acid; 5FU: 5-fluorouracil; FOLFIRI: Regimen of irinotecan, infusional fluorouracil and leucovorin; AIO: Arbeitgemeinschaft internistische onkologie; CRYSTAL: CRYSTAL trial (cetuximab combined with irinotecan in first-line therapy for metastatic colorectal cancer); FIRE-3: AIO KRK-0306 trial; KRAS: v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog.