Cetuximab plus irinotecan in pretreated metastatic colorectal cancer patients: The ELSIE study

Table 1 Patients and disease characteristics at baseline (intention-to-treat/safety population)

Characteristic	Patients(n = 123)
Patient characteristics
Median age, yr (range)	56 (24-78)
Age categories, n (%)
< 65 yr	92 (74.8)
≥ 65-75 yr	28 (22.8)
≥ 75 yr	3 (2.4)
Gender, n (%)
Male	73 (59.3)
Female	50 (40.7)
Ethnic origin, n (%)
Caucasian	9 (7.3)
Asian (Chinese)	66 (53.7)
Asian (non Chinese)	48 (39.0)
Karnofsky performance status, n (%)
80	39 (31.7)
90	52 (42.3)
100	32 (26.0)
Disease characteristics
Median duration of CRC, mo (range)	15.7 (2-78)
Median duration of mCRC, mo (range)	8.8 (1-56)
Localization of tumor, n (%)
Colon	71 (57.7)
Rectum	49 (39.8)
Colon and rectum	3 (2.4)
No. of organs with metastasis, n (%)
1	51 (41.5)
2	53 (43.1)
3	12 (9.8)
> 3	7 (5.7)
Previous treatment, n (%)
No. of previous treatment lines (non-adjuvant)
1	66 (53.7)
2	37 (30.1)
3	20 (16.3)
Previous adjuvant chemotherapy	37 (30.1)
Previous non-adjuvant oxaliplatin therapy	50 (40.7)
Most recent irinotecan therapy, n (%)
100 or 125 mg/m2 weekly for 4 consecutive wk followed by 2 wk of rest	1 (0.8)
100 or 125 mg/m2 weekly for 2 consecutive wk out of 3	15 (12.2)
180 or 210 mg/m2 every 2 wk1	94 (76.4)
300 or 350 mg/m2 every 3 wk	9 (7.3)
Other	4 (3.3)
Type of therapy, n (%)
Irinotecan monotherapy	10 (8.1)
Irinotecan + 5-FU or analog	104 (84.6)
Irinotecan + 5-FU or analog + other	8 (6.5)
Irinotecan + other	4 (3.3)
Median duration, wk (Q1-Q3)	14.3 (7.3-22.4)
Best overall response to most recent irinotecan treatment, n (%)
Complete response	3 (2.4)
Partial response	17 (13.8)
Stable disease	43 (35.0)
Progressive disease	59 (48.0)
Missing	1 (0.8)

¹One patient received 210 mg/m² and 93 received 180 mg/m² every 2 wk. CRC: Colorectal cancer; 5-FU: 5-fluorouracil; mCRC: Metastatic colorectal cancer; PD: Progressive disease; Q1-Q3: Interquartile range.