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

Table 4 Overall survival in patient subgroups (intention-to-treat/safety population)

Prognostic factors	n	No. of deaths n (%)	Median survival
			Months	95% CI
Age (yr)
< 65	92	77 (83.7)	9.6	(7.9-11.8)
≥ 65	31	28 (90.3)	7.5	(5.7-12.9)
Gender
Male	73	64 (87.7)	9.5	(7.3-11.7)
Female	50	41 (82.0)	8.9	(6.4-16.5)
Stage based on TMN classification at first diagnosis
I/II	11	10 (90.9)	12.8	(5.6-14.6)
III	24	22 (91.7)	9.3	(5.1-11.3)
IV	80	67 (83.8)	9.5	(7.5-13.0)
unknown	8	6 (75.0)	4.9	(2.9-NA)
Karnofsky performance status
≤ 80	39	36 (92.3)	5.7	(2.6-11.3)
> 80	84	69 (82.1)	10.3	(8.9-13.3)
No. of previous non-adjuvant lines
1	66	57 (86.4)	11.2	(9.1-13.3)
2	37	31 (83.8)	5.9	(3.8-9.1)
≥ 3	20	17 (85.0)	9.3	(3.6-17.7)
Time from end of last course of most recent irinotecan treatment to progression
≤ 30 d	86	76 (88.4)	8.8	(7.1-11.3)
> 30 d	37	29 (78.4)	10.6	(5.7-14.6)
Best response of most recent irinotecan schedule1
CR/PR	20	14 (70.0)	15.6	(8.6-9.4)
PD/SD	102	90 (88.2)	8.9	(7.0-11.0)
No. of metastatic sites
1	51	44 (86.3)	10.6	(7.9-13.3)
≥ 2	72	61 (84.7)	8.4	(6.9-11.0)
BSA
≤ 1.6 m2	42	34 (81.0)	8.6	(6.4-16.5)
> 1.6 m2 to ≤ 1.8 m2	48	41 (85.4)	10	(6.9-13.0)
> 1.8 m2	33	30 (90.9)	9.5	(5.7-11.8)
Early acne-like rash during the first 21 d2
No	38	34 (89.5)	6.2	(3.3-11.3)
Yes	85	71 (83.5)	9.5	(7.2-12.3)
Grade 1 or 2	81	67 (82.5)	9.6	(7.4-13.7)
Grade 3 or 4	4	4 (100)	3	(2.1-10.9)

¹Best response was missing for 1 patient who died at 2.5 mo;

²Landmark analysis. BSA: Body surface area; NA: Not available; TMN: Tumor, node, metastasis; CR: Complete response; PR: Partial response; PD: Progressive disease; SD: Stable disease.