The relationship between rash, tumour KRAS mutation status and clinical and quality of life outcomes in patients with advanced colorectal cancer treated with cetuximab in the NCIC CTG/AGITG CO.17

Figures & data

Figure 1. Disposition of patients included in rash analyses.

Table I. Baseline characteristics of patients included in the analysis.

(1) Patients with Wild-type Kras.
Characteristic	BSC (N = 105)	Cetuximab Grade 0 or 1 (N = 55)	Cetuximab Grade 2+ (N = 62)	p-value*
Age (year)				0.20
< 65	53 (50.5%)	36 (65.5%)	36 (58.1%)
≥ 65	52 (49.5%)	19 (34.5%)	26 (41.9%)
Gender				0.02
Female	34 (32.4%)	24 (43.6%)	12 (19.4%)
Male	71 (67.6%)	154 (56.4%)	50 (80.6%)
ECOG performance status				0.04
0 or 1	83 (79.0%)	40 (72.7%)	56 (90.3%)
2	22 (21.0%)	15 (27.3%)	6 (9.7%)
Site of primary cancer				0.30
Colon only	57 (54.3%)	35 (63.6%)	38 (61.3%)
Rectum only	30 (28.6%)	9 (16.4%)	10 (16.1%)
Both colon and rectum	18 (17.1%)	11 (20.0%)	14 (22.6%)
Number of organ sites				0.04
≤ 2	39 (37.1%)	28 (50.9%)	35 (56.5%)
> 2	66 (62.9%)	27 (49.1%)	27 (43.5%)
Presence of liver and lung metastases				0.22
Yes	89 (84.8%)	41 (74.5%)	53 (85.5%)
No	16 (15.2%)	14 (25.5%)	9 (14.5%)

(2) Patients with mutated Kras.
Characteristic	BSC (N = 79)	Cetuximab Grade 0 or 1 (N = 50)	Cetuximab Grade 2+ (N = 31)	p-value*
Age (year)				0.58
< 65	49 (62.0%)	28 (56.0%)	21 (67.7%)
≥ 65	30 (38.0%)	22 (44.0%)	10 (32.3%)
Gender				0.07
Female	27 (34.2%)	26 (52.0%)	9 (29.0%)
Male	52 (65.8%)	24 (48.0%)	22 (71.0%)
ECOG performance status				0.60
0 or 1	63 (79.7%)	37 (74.0%)	26 (83.9%)
2	16 (20.3%)	13 (26.0%)	5 (16.1%)
Site of primary cancer				0.20
Colon only	50 (63.3%)	38 (76.0%)	17 (54.8%)
Rectum only	18 (22.8%)	5 (10.0%)	9 (29.0%)
Both colon and rectum	11 (13.9%)	7 (14.0%)	5 (16.1%)
Number of organ sites				0.04
≤ 2	39 (49.4%)	15 (30.0%)	17 (54.8%)
> 2	40 (50.6%)	35 (70.0%)	14 (45.2%)
Presence of liver and lung metastases				0.68
Yes	63 (79.7%)	41 (82.0%)	23 (74.2%)
No	16 (20.3%)	9 (18.0%)	8 (25.8%)

Figure 2. (A) OS for patients with wild-type Kras. (B) PFS for patients with wild-type Kras.

Figure 3. (A) OS for patients with mutated Kras. (B) PFS for patients with mutated Kras.

Table II. Dose intensity, omissions and reductions of cetuximab by worst rash grade by day 28.

(1) Patients with Wild-type Kras.
	Cetuximab Grade 0 or 1 (N = 55)	Cetuximab Grade 2+ (N = 62)
Dose intensity (mg/m^2)
Median	249	238
Range	174–262	117–256
Proportion receiving ≥ 90% of planned dose	90%	62%
Proportion experiencing dose reduction due to rash	0%	8%
Proportion experiencing dose omission duo to rash	4%	32%

(2) Patients with mutated Kras.
	Cetuximab Grade 0 or 1 (N = 50)	Cetuximab Grade 2+ (N = 32)
Dose intensity (mg/m^2)
Median	249	236
Range	150–258	141–261
Proportion receiving ≥ 90% of planned dose	87%	68%
Proportion experiencing dose reduction due to rash	0%	6%
Proportion experiencing dose omission due to rash	2%	25%

Table III. Mean change scores from baseline for physical function and global health status with wild-type Kras.

	BSC		Cetuximab Grade 0 or 1		Cetuximab Grade 2+
	N	Mean (SD)	N	Mean (SD)	N	Mean (SD)
Week 8
Physical function	62	−7.3 (20.3)	40	0.5 (15.7)	50	−1.6 (11.7)
Global health	63	−7.7 (21.3)	37	4.7 (22.5)	51	2.1 (17.4)
Week 16
Physical function	36	−13.8 (21.5)	26	−2.3 (23.4)	43	−4.1 (13.9)
Global health	36	−18.1 (27.6)	26	1.9 (26.6)	44	−1.5 (17.5)

Table IV. Proportion of patients experiencing deterioration from baseline scores for physical function and global health status in patients with wild-type Kras.

	BSC		Cetuximab Grade 0 or 1		Cetuximab Grade 2+
	Total	Deteriorated (%)	Total	Deteriorated (%)	Total	Deteriorated (%)
Week 8
Physical function	62	16 (25.8)	40	7 (17.5)	50	9 (18.0)
Global health	63	23 (36.5)	37	7 (18.9)	51	7 (13.7)
Week 16
Physical function	36	17 (47.2)	26	5 (19.2)	43	10 (23.3)
Global health	36	21 (58.3)	26	7 (26.9)	44	13 (29.6)