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

Table 1 Patient characteristics at baseline

Characteristic	ITT population		KRAS population
			KRAS wild-type		KRAS mutant
	FOLFOX6 plus cetuximab (n = 77)	FOLFIRI plus cetuximab (n = 74)	FOLFOX6 plus cetuximab (n = 34)	FOLFIRI plus cetuximab (n = 28)	FOLFOX6 plus cetuximab (n = 23)	FOLFIRI plus cetuximab (n = 32)
Gender, n (%)
Male	43 (56)	45 (61)	22 (65)	17 (61)	11 (48)	21 (66)
Female	34 (44)	29 (39)	12 (35)	11 (39)	12 (52)	11 (34)
Age (yr)
Median (Q1-Q3)	62.0 (54-67)	62.5 (54-68)	62.5 (55-67)	64.0 (56-68)	63.0 (49-68)	62.5 (54-70)
< 65, n (%)	46 (60)	46 (62)	19 (56)	17 (61)	13 (57)	19 (59)
> 65, n (%)	31 (40)	28 (38)	15 (44)	11 (39)	10 (43)	13 (41)
ECOG PS, n (%)
0	46 (60)	38 (51)	20 (59)	17 (61)	13 (57)	14 (44)
1	31 (40)	36 (49)	14 (41)	11 (39)	10 (43)	18 (56)
Primary tumor location, n (%)
Colon	52 (68)	47 (64)	26 (76)	15 (54)	13 (57)	22 (69)
Rectum	25 (32)	27 (36)	8 (24)	13 (46)	10 (43)	10 (31)
Metastasis1, n (%)	45 (58)a	46 (62)	17 (50)	18 (64)	16 (70)	18 (56)
Organs with metastases, n (%)
1-2	59 (77)	56 (76)	28 (82)	23 (82)	17 (74)	26 (81)
> 2	18 (23)	18 (24)	6 (18)	5 (18)	6 (26)	6 (19)
Metastatic sites2, n (%)
Intestine/bowel	12 (16)	12 (16)	3 (9)	6 (21)	6 (26)	5 (16)
Liver	66 (86)	63 (85)	30 (88)	24 (86)	20 (87)	26 (81)
Lung	27 (35)	28 (38)	11 (32)	10 (36)	8 (35)	10 (31)
Lymph nodes
Chest	7 (9)	5 (7)	2 (6)	2 (7)	3 (13)	2 (6)
Abdomen	22 (29)	24 (32)	9 (26)	8 (29)	5 (22)	8 (25)
Bone	2 (3)	4 (5)	0 (0)	1 (4)	2 (9)	1 (3)
Other	10 (13)	10 (14)	5 (15)	3 (11)	2 (9)	4 (13)
Duration of disease, mo
CRC, median (Q1-Q3)	2.1a (1-15)	1.9 (1-14)	2.2 (1-18)	1.8 (1-6)	1.8 (1-3)	2.4 (1-18)
mCRC median (Q1-Q3)	1.4 (1-2)	1.2 (1-2)	1.1 (1-2)	1.0 (1-2)	1.3 (1-2)	1.4 (1-2)
EGFR status, n (%)
Detectable	43 (56)	46 (62)	21 (62)	20 (71)	17 (74)	24 (75)
Undetectable	17 (22)	12 (16)	10 (29)	4 (14)	5 (22)	7 (22)
Non evaluable	17 (22)	16 (22)	3 (9)	4 (14)	1 (4)	1 (3)
Prior treatment, n (%)
At least 1 therapy	63 (82)	59 (80)	31 (91)	22 (79)	19 (83)	29 (91)
Adjuvant chemotherapy3	14 (18)	10 (14)	9 (26)	2 (7)	2 (9)	6 (19)
Surgery	61 (79)	58 (78)	30 (88)	22 (79)	18 (78)	29 (91)
Other	8 (10)	5 (7)	3 (9)	2 (7)	3 (13)	2 (6)

¹Metastases detected within 1 mo of tumor diagnosis;

²Patients with >1 metastasis per organ site, the organ site was counted once only;

³Three patients included with rectal cancer received neoadjuvant therapy;

^aValue determined from 76 patients. Patients receiving FOLFOX6 plus cetuximab (arm A) and those receiving FOLFIRI plus cetuximab (arm B). ITT: Intention to treat; FOLFOX: 5-fluorouracil (5-FU) folinic acid (FA) and oxaliplatin; FOLFIRI: 5-FU FA and irinotecan; ECOG: Eastern Cooperative Oncology Group; PS: Performance status; Q1-Q3: Interquartile range; mCRC: Metastatic colorectal cancer.