Cetuximab plus FOLFOX6 or FOLFIRI in metastatic colorectal cancer: CECOG trial

Table 3 Efficacy in the ITT population

Characteristic	FOLFOX6 plus cetuximab (arm A, n = 77)	FOLFIRI plus cetuximab (arm B, n = 74)
PFS
Events, n (%)	61 (79)	59 (80)
Median1, mo (95% CI)	8.6 (6.3-9.7)	8.3 (7.4-8.7)
Log rank P-value	0.7375
Hazard ratio (95% CI)	1.06 (0.74-1.52)
PFS rate1, % (95% CI)
3 mo	92 (85-98)	78 (68-88)
6 mo	69 (58-80)	69 (58-80)
9 mo	45 (33-58)	34 (23-46)
12 mo	18 (8-27)	18 (8-27)
Overall survival
Events, n (%)	54 (70)	50 (68)
Median1, mo (95% CI)	17.4 (14.9-22.6)	18.9 (14.7-23.9)
Logrank P-value	0.9230
Hazard ratio2 (95% CI)	0.98 (0.67-1.44)
Survival rate1, % (95% CI)
9 mo	79 (70-88)	79 (70-89)
12 mo	70 (60-80)	71 (60-81)
18 mo	46 (35-57)	53 (42-65)
24 mo	33 (22-44)	38 (26-50)
Best overall response, n (%)
CR	2 (3)	6 (8)
PR	31 (40)	27 (36)
SD	31 (40)	24 (32)
PD	6 (8)	9 (12)
NE	7 (9)	8 (11)
Objective response rate, n (%)	33 (43)	33 (45)
95% CI	32-55	33-57
Odds ratio (95% CI)	0.93 (0.49-1.77)

¹Median time and rates are based on Kaplan-Meier estimates;

²Hazard ratio and corresponding 95% CI based on unadjusted Cox proportional hazard model: hazard rate FOLFIRI plus cetuximab divided by hazard rate FOLFOX6 plus cetuximab. CR: Complete response; NE: Not evaluable; PD: Progressive disease; PFS: Progression-free survival; PR: Partial response; SD: Stable disease.