Cetuximab in combination with irinotecan/5-fluorouracil/folinic acid (FOLFIRI) in the initial treatment of metastatic colorectal cancer: a multicentre two-part phase I/II study

Table 1 Patient and disease characteristics and prior treatments

Characteristics	LD 5-FU (n = 7)	HD 5-FU (n = 45)	Total (n = 52)
Gender, M/F (%)	57/43	64/36	63.5/36.5
Median age, years [range]	66 [49–73]	61 [25–77]	61 [25–77]
Median KPS [range]	100 [80–100]	100 [60–100]	100 [60–100]
Median duration of disease, months [range]	1.4 [1–25]	1.5 [0–84]	1.5 [0–84]
Primary tumour site (%):
Colon	86	67	69
Rectum	14	33	31
Previous adjuvant chemotherapy (%)	14	20	19
Number of involved organs (%) ≤ 2	100	93	94
Normal WBC at baseline (%)	100	96	96
Normal LDH at baseline (%)	57	49	50
Normal ALP at baseline (%)	29	36	35
EGFR status (%):^a
0–≤10	43	42	42
>10–≤20	14	13	14
>20–≤35	29	13	15
>35	14	31	29

^aPercentage of positive cells; LD = low-dose; HD = high-dose; KPS = Karnofsky Performance Status; WBC = white blood cell; LDH = lactate dehydrogenase; ALP = alkaline phosphatase; EGFR = epidermal growth factor receptor.

ISSN: 1471-2407