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

Table 2 Extent of exposure to cetuximab and irinotecan (intention-to-treat/safety population)

Characteristic	Patients (n = 123)
	Cetuximab1	Irinotecan2
Duration, wk
Median	12.0	12.0
Q1-Q3	6.0-25.0	6.0-25.6
Total number of infusions, n (%)
0	0	2 (1.6)
1-5	13 (10.6)	57 (46.3)
6-10	42 (34.1)	35 (28.5)
11-20	30 (24.4)	19 (15.4)2
21-30	20 (16.3)	6 (4.9)
31-40	7 (5.7)	2 (1.6)
41-50	5 (4.1)	1 (0.8)
> 50	6 (4.9)	1 (0.8)
Cumulative dose, mg/m2
Median	3143.7	894.8
Q1-Q3	1650.8-6110.6	532.0-1980.4
Cetuximab dose intensity, mg/m2 per week
Median	246.7
Q1-Q3	236.0-250.3
Irinotecan dose intensity, mg/m2 per 6 wk
Median		507.8
Q1-Q3		407.6-539.5
Relative dose intensity, n (%)
< 60%	2 (1.7)	5 (4.3)
60% to 80%	5 (4.2)	21 (17.9)
80% to 90%	6 (5.0)	15 (12.8)
≥ 90%	107 (89.2)	76 (65.0)
Patients who stopped irinotecan and received cetuximab, n (%)	14 (11.4)
Median duration of cetuximab monotherapy after stopping irinotecan, wk (range)	2.5 (0.9-23.0)
Patients who stopped combination treatment and received irinotecan only, n (%)	0

¹Relative dose intensity calculated for patients receiving at least 1 maintenance dose only, the initial dose was excluded for the calculation of relative dose intensity; ²Duration, cumulative dose by cycle and relative dose intensity overall and by cycle were not calculated for 4 patients who received “other” irinotecan regimens (n = 119 for these calculations).